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As I race around at a frantic pace, trying to "make it" in the academic world, I wonder what I could say to all of you that would be worth you taking time from your frantic schedules to read. Much of the news you need to know is distributed throughout this newsletter, so I will simply point to the highlights of what AMP is doing.

The annual meeting is coming down the home stretch, with a series of excellent talks and discussions. Pre-meeting workshops are planned and many molecular companies are registered as exhibitors.

The AMP Award for Excellence, sponsored by Visible Genetics, will be awarded to Henry Ehrlich this year. I am pleased to announce that Bert Vogelstein will be the recipient of this award in 2001.

Trainee members of AMP will be pleased to learn that Clinical Micro Sensors of Pasadena, California (Ed. Note: CMS is now wholly owned by Motorola; see note below) is sponsoring three awards for the best trainee abstracts and posters at the AMP meeting this year, as well as for 2001 and 2002. The award is $1250 per trainee winner. Winners will be selected by the Training and Education Committee and announced at the business meeting in Denver on November 11^th. Best of luck to all trainees, and may three of you go home a little richer! All AMP meeting attendees are invited to attend a reception sponsored by CMS immediately following the Business Meeting to honor the awardees.

On the regulatory front, AMP is playing a major role in the new efforts to bring greater oversight to genetic testing, through SACGT, the CDC Forum and the FDA. Karl Voelkerding, AMP President-elect has played a major role in assuring that AMP has a voice in the discussions. The outcome of these discussions will have tremendous impact on genetic testing labs in the future. AMP is working with FDA to hold the second Professional Society Round Table in October to brainstorm about mechanisms for FDA oversight of genetic testing, which has been proposed by SACGT.

AMP provided comments on the proposed training requirements for board certification in Molecular Genetic Pathology by the American Board of Pathology and the American Board of Medical Genetics. Thanks to Tony Killeen and the Training and Education Committee members.

The Clinical Practice Committee is working to survey AMP membership about the proposal to have the AMP Test Directory combined with the GeneTests web site. Please complete your surveys and come to the Subdivision luncheon meetings at the annual meetings for further discussion.

The official AMP journal, The Journal of Molecular Diagnostics continues to thrive. I encourage you to submit your manuscripts JMD for publication to reach the molecular diagnostics community. JMD will be undergoing review by the National Library of Medicine in October.

Many thanks to all of you I have served with this year as President of AMP. I look forward to working with our incoming President, Karl, during the coming year. It is you as members of this organization that make AMP so wonderful and useful professionally. I hope we can continue the spirit of volunteering and working together to shape the practice of molecular pathology for years to come.

-Debra G. B. Leonard, MD, PhD, AMP President

e-mail: debraleo@mail.med.upenn.edu

This year’s AMP Program Committee has worked very hard to put together a program of plenary sessions and workshops that we hope will lead to an exciting and informative Annual Meeting. When you attend this year’s meeting at the Hyatt Regency Hotel in Denver, we on the Program Committee want you to come away feeling invigorated by the speakers, workshops and discussions you attend, knowing that you have heard the latest scientific, clinical, technological and political developments in molecular pathology. We hope you will have a chance to renew friendships with colleagues you have met at earlier meetings and have an opportunity to make new acquaintances.

To that end, the Program Committee has assembled plenary sessions, workshops, and abstract sessions which will update you about the latest scientific and technological developments relevant to our field, provide you with new insights and information about quality control issues affecting your laboratory, give some new ideas about novel, more efficient or easier ways to set up a familiar molecular test or lead you to a new molecular target you had not previously considered including in your laboratory’s test menu. In short, we want to provide you with those experiences that we as a committee value most about AMP meetings, that is, exposure to excellent scientific presentations, a chance to share our clinical experiences informally with colleagues or more formally in workshops, an opportunity to learn about technological and methodological advances which will affect our laboratories and an opportunity to hear about and discuss political developments on the national level which impact the practice of molecular diagnostics.

As an introduction, let me describe for you how the meeting has been structured so you will see how the Program has been designed to try to meet these goals:

AMP Award for Excellence: The formal AMP program will start Friday morning, November 10, with a our third annual AMP Award for Excellence in Molecular Diagnostics lecture, an award which has been sponsored each year by Visible Genetics, Inc. We are very honored and pleased to have Henry Erlich as this year’s Award recipient. Dr. Erlich is truly one of the fathers of molecular diagnostics. He was one of the pioneers of PCR technology. His early papers about methods to use PCR for genotyping or mutation detection, for DNA sequencing and for amplification of DNA from single hairs, single sperm and single cells have all had major impacts on clinical and forensic molecular testing.

Plenary Lectures: In organizing plenary lectures this year, the Program Committee has featured topics that overlap the content areas of the traditional AMP subdivisions of hematopathology, genetics, infectious disease and solid tumors. We hope that with this format, the plenary sessions will provide valuable information to you no matter what your specific interests, area of specialization or specific laboratory focus. As you will see, a hematopathology lecture will overlap with infectious disease, the infectious disease lecture will overlap with genetics and a solid tumor lecture will overlap with technologic advances.

The hematopathology plenary lectures will follow our AMP Award for Excellence lecture and have been organized by Dan Arber and Adam Bagg. Lawrence Weiss from the City of Hope National Medical Center will speak on the role of Epstein Barr virus in malignancies. He will be followed by James Downing from St. Jude Hospital who will speak on core binding factors in leukemias.

On Saturday morning, we will have a combined Genetics and Infectious Disease plenary session organized by Tony Shrimpton, Rick Press, Angie Caliendo and Steve Dumler followed by the Solid Tumors plenary session organized by Carlos Cordon-Cardo and Bill Bennett. At the joint Genetics and Infectious Disease Plenary Session, we will hear from Rudy Leibl of Columbia University on the genetics of obesity and from Emile Skamene from McGill University on the genetics of mycobacterial infection.

The Solid Tumors speakers include Dennis Slamon from UCLA and Tobin Orntoff from Aarhus University Hospital in Denmark. Dr. Slamon was responsible for discovering the prognostic importance of HER-2/neu gene amplification in breast cancer and then developed the monoclonal antibody to HER-2/neu, heregulin, which has been shown in clinical trials to be a very promising agent for treatment of recurrent breast cancer. Dr. Orntoff will discuss microarray technology and the use of that technology to develop a molecular classification schema for bladder cancer based on differences in patterns of gene expression.

The two Sunday morning plenary sessions will be devoted to panel discussions of two of the most important political developments affecting the practice of molecular diagnostics: the implications of the recommendations made by the Secretary’s Advisory Committee on Genetic Testing (SACGT) and the CLIAC committee and the current status of gene patenting regulations. These sessions have been organized by Linda Wasserman and Richard Scheuermann. We believe that these topics have vital importance to us as an organization and as a profession. Our hope in organizing these sessions has been to provide speakers who represent the diversity of opinions and expertise relating to these topics and to structure the sessions so that the audience will have sufficient time to raise questions and discuss these issues with the panelists. Each panelist has been requested to prepare a 15 to 20 minute presentation so there will sufficient time for meeting attendees to respond with questions and comments.

Panelists on the SACGT/CLIAC panel include Ed McCabe, the chairman of SACGT and AMP members Brad Popovich and Pat Charache. The definitions of genetic testing developed during the course of the Committee’s work and their recommendations regarding implementation of these recommendations have important implications for the practice of molecular diagnostics. Dr. McCabe will describe the purpose of SACGT and the outcome of the Committee’s deliberations. Drs. Popovich and Charache have been asked to outline their views about the Committee’s work and how it may impact our laboratories.

The panelists for the plenary session on Gene Patenting include John Doll, Director of the Technology Center of the United States Patent and Trademark Office, David Korn, Vice President of the Department of Biomedical and Health Science Research, American Association of Medical Colleges (AAMC) and Lila Feisee, Director of Federal Government Relations and Intellectual Property, Biotechnology Industry Organization. In putting together the session panel, we attempted to identify representatives from industry, academic medicine and the government to provide a cross-section of perspectives concerning this complicated issue. The topic of gene patenting has important implications for AMP. Because of our diverse backgrounds, it was felt that we could all benefit from an open discussion of the issues surrounding gene patenting and the current evaluation criteria being used by the Patent and Trademark Office.

Workshops: In selecting workshop topics, the Program Committee has emphasized clinical topics. Several workshops have been organized around technological advances, including quantitative, real-time PCR technology, the use of microarrays, practical tips about the use of NIH web-based resources and methods for HCV and HIV genotyping. In addition, issues relating to proficiency testing and to methods of quality control and test validation are the topics of several workshops.

Workshops begin Thursday night, November 9, with a very timely comparison of methods for quantitative real-time PCR. This workshop has been organized by Barb Griffith and Kent Williams, our medical technology representatives, and will include a presentation by Elaine Lyon from ARUP Laboratories on her experiences with the Roche LightCycler and a presentation by Anami Patel from St. Jude Children’s Research Hospital on his experiences with the ABI TaqMan system. Further discussion of clinical applications of quantitative real time PCR, as applied to minimal residual disease detection, will be the focus of the Friday afternoon Hematopathology workshop and the Saturday afternoon Solid Tumor workshop. Speakers in these workshops will describe their experiences with this methodology in detecting circulating tumor cells and in evaluating micrometastases. Clinical applications of microarray technology will be the focus of the Friday afternoon Solid Tumor workshop.

The general areas of proficiency testing and methods of quality control and test validation will be addressed in several workshops. A Medical Technologists workshop Friday afternoon will present the results of the recent AMP member survey on quality control and test validation methods used by our laboratories. Survey results will be posted as well on the AMP web site. Results of the two sample exchanges sent to participating AMP laboratories this summer will be discussed on Friday afternoon in the Hematopathology workshop. Issues relating to proficiency testing will be the topics of the Friday afternoon Infectious Disease workshop on the NCCLS guidelines for quantitative testing of infectious disease and the Saturday afternoon Genetics workshop on CAP proficiency testing for Fragile X and Cystic Fibrosis.

Abstracts: Posters sessions will be held on both Friday and Saturday of the meeting. Over 100 abstracts were submitted, representing each of the four AMP subdivisions. Due to this excellent response, about half of the posters will be on display each day; two AMP subdivisions represented each day. Although the posters will be up all day for review, the authors will be present at their posters from 3:30-4:30 on Friday and from 2:30-3:30 on Saturday. Several posters are being prepared by trainees in molecular pathology. These will be segregated during the poster sessions and will be eligible for recognition. Clinical Micro Sensors, a wholly owned division of Motorola, has established a Young Investigator Award, which will be presented to three trainee award recipients at the Saturday afternoon business meeting. These awards are described in more detail in the report from the Training and Education Committee below. Be sure and stop by the posters to see the excellent research projects being pursued by our members and plan to attend the CMS sponsored reception after the Business Meeting to honor the Young Investigator awardees.

As you can see, we expect to provide two and a half very full days of meetings and workshops. We look forward to seeing you all in Denver

-Linda Wasserman, MD, PhD, Program Chair

e-mail: lwasserman@ucsd.edu

5:30-7:00 Medical technology selected technical topics: "Comparison of Methods for Real Time PCR". Moderators: Barbara Griffith, MS, U. New Mexico & W. Kent Williams, MT, CLSp(MB), St. Jude Children’s Research Hosp.

Using LightCycler Technology for Quantitative PCR and Mutation Detection. Elaine Lyon, PhD, ARUP Laboratories

Clinical Application and Validation of Real-Time RT-PCR-(TAQ-man) in the Diagnosis of Cancer. Anami Patel, PhD, St. Jude.

9:00-10:30 AMP Committee Meetings

7:50-8:00 Opening Remarks. Linda Wasserman, MD, PhD, University of California, San Diego

8:00-9:30 AMP AWARD FOR EXCELLENCE IN MOLECULAR DIAGNOSTICS LECTURE sponsored by Visible Genetics. Henry Ehrlich, PhD, Roche.

9:30-10:00 Break

10:00-11:45 PLENARY SESSION I: HEMEPATH

Moderators: Daniel Arber, MD, City of Hope & Adam Bagg, MD, University of Pennsylvania

10:00-10:45 EBV in Malignancies. Lawrence M. Weiss, MD, City of Hope National Medical Center

11:00-11:45 Core Binding Factor Leukemias. James Downing, MD, St. Jude Children’s Research Hospital

12:00-1:00 Lunch/Visit Posters and Exhibits

Hemepath Subdivision Business Mtg/Lunch

Inf. Dis. Subdivision Business Mtg/Lunch

1:00-2:30 WORKSHOPS SESSION A

Moderators: Angela M. Caliendo, MD, PhD, Emory University Hospital & Roberta Madej, MS, MBA, Roche Molecular Systems

Review and Discussion of NCCLS guidelines for methods for quantitative testing of infectious disease. Roberta Madej, Roche.

HEMATOPATHOLOGY WORKSHOP 1

Moderator: A. Bagg, MD, U. of Pennsylvania

Current Practice of Q-PCR & Minimal Residual Disease Testing Survey Results. Janina Longtine, MD, Brigham & Women’s Hospital

Experience with TaqMan RT-PCR quantification in leukemias. Sheila A. Shurtleff, PhD, St. Jude Children’s Research Hospital

Real-time PCR quantitation of Cyclin D1 in non-Hodgkin’s lymphomas and leukemias. Kojo Elenitoba-Johnson, MD, ARUP Laboratories Inc., Salt Lake City, UT.

2:30-3:00 Break

Moderators: B. Griffith, MS, U. NM & W. Kent Williams, MT, CLSp MB, St. Jude.

Roberta Madej, MS, MBA, Roche; Lars Mouritsen BS, CLSp(MB), ARUP; James H. Bowden BA, CLSp(MB), UVa; Qi Wei BS, CLSp(MB), Children’s Hospital, Denver

4:00-4:30 Break

4:30-6:00 WORKSHOPS SESSIONS B

Moderator: Richard Press, MD, PhD, Oregon Health Sciences University

Moderator: Carlos Cordon-Cardo, MD., PhD

Memorial Sloan-Kettering

Use of Microarrays. Tobin Orntoff, MD, DMSci, Aarhus University Hospital

6:00-7:00 WELCOMING RECEPTION

7:00-10:00 AMP Council Meeting

7:00-7:55 Breakfast. Put up posters/exhibits

7:00-8:00 JMD Editorial Board Meeting

Moderators: Antony Shrimpton, PhD, SUNY Syracuse & AM Caliendo, MD, PhD, Emory.

8:00-8:45 Genetics of Obesity. Rudi Leibl, PhD, Columbia University

9:00-9:45 Genetics of Mycobacterial Infection. Emile Skamene, MD, FRCP (C) FACP, FRSC, McGill Univ., & Montreal General Hospital

9:45-10:15 Break

10:15- 11:45 PLENARY SESSION III:

Moderators: C. Cordon-Cardo, MD, PhD, MSKCC & William P. Bennett, MD, City of Hope National Medical Center

10:15-11:00 Use of the anti HER-2/neu antibody Herceptin in the treatment of human breast cancer: Biologic rationale and clinical results. Dennis J. Slamon, MD, UCLA

11:15-11:45 Molecular Classification of Bladder Cancer Using Microarrays. Tobin Orntoff MD, DMSci, Aarhus University Hospital

12:00-1:00 Lunch/Visit Posters and Exhibits

1:00-2:30 WORKSHOPS SESSION C

Moderator: W. Bennet, MD City of Hope

Detection of circulating tumor cells and micrometastases. Ronald Ghoshein, MD, MSKCC & Richard Cote, MD, USC

Moderator: A. Shrimpton, PhD, SUNY, Syr.

CAP Proficiency Testing for Fragile X and CF. Timothy Stenzel, MD, PhD, Duke Univ. Med. Ctr.; W. Grody, MD, PhD, UCLA; Walter Noll, MD, Dartmouth-Hitchcock Med. Ctr.; Brad Popovich, PhD, Ore. Health Sci. Univ.; Karen Snow, PhD, Mayo Clinic

2:30-3:00 Visit Exhibits, Posters

3:00-4:30 WORKSHOPS SESSION D

Moderators: D. Arber, MD, City of Hope & Rita Braziel, MD, Ore. Health Sci. Univ.

Moderators: Angela M. Caliendo, MD, PhD

Emory Univ. Hosp. & J. Stephen Dumler, MD, Johns Hopkins Medical Institutions

HCV genotyping. Frederick S. Nolte, PhD, Emory University Hospital

HIV genotyping and phenotyping. Timothy M. Alcorn, PhD, LabCorp

4:30-5:00 Break

5:00-6:00 AMP BUSINESS MEETING

6:00-7:30 Reception for AMP Young Investigator Award winners sponsored by CMS (all are welcome)

6:30-8:00 Canadian Pathologists Meeting

7:00-7:50 Continental Breakfast

Moderators: Linda Wasserman, MD, PhD, UCSD & Richard Scheuermann, PhD, Univ. of Texas Southwestern Medical Center

DISCUSSION. Edward McCabe, MD, UCLA; Patricia Charache, MD, Johns Hopkins Medical Institution; Bradley Popovich, PhD; Oregon Health Sciences University

9:30-10:00 Break

Moderators: L. Wasserman, MD, PhD, UCSD & R. Scheuermann, PhD, UTSMC

Discussion. John Doll, Director, Technology Center , US Patent & Trademark Office & David Korn, MD, Dept. Biomedical & Health Science Research, American Association of Medical Colleges, Washington DC

11:45 Adjourn

Fourteen workshops will be presented by various companies during the morning and afternoon of Thursday, November 9. Brief descriptions of the workshops are included below.

10:00 AM-Noon

• Ambion
• BD Biosciences: Molecular Diagnostics
• Gentra Systems

11:00 AM-1:00 PM

• Bio-Rad
• Intergen
• Promega
• Vysis

2:00 PM-3:00 PM

• Nanogen

2:00 PM-3:30 PM

• Roche

2:00 PM-4:00 PM

• Third Wave Technologies

3:00 PM-4:00 PM

• Visible Genetics

3:00 PM-5:00 PM

• Qiagen
• Stratagene
• InVivo Scribe

AMBION RNA DIAGNOSTICS - Solutions for Molecular Diagnostics

This workshop will focus on solutions for problems that are commonly encountered within a molecular diagnostic laboratory. These include 1) robust controls (external and internal) for infectious disease testing, 2) genetic disease mutation detection scanning and 3) RNA stability in clinical specimens. Armored RNA controls and standards address the common lack of robust, homogeneous controls for RNA-based clinical assays. Additionally, a rapid, cost-effective method of mutation scanning (NIRCA) will be discussed and reduced to clinical practice for p53 screening. Lastly, solid tumor and tissue preservation for quality RNA or DNA isolation from recent or archived specimens will be described using RNAlater.

BD BIOSCIENCES - Molecular Diagnostics for the Future: Strand Displacement Amplification, the BDProbeTec ET System and Homebrew Applications

Nucleic acid amplification in the clinical laboratory recently came of age with the launch of the BDProbeTec ET system. This instrument is based upon BD's proprietary strand displacement amplification (SDA) technology and permits real-time detection of SDA products in sealed microwells, thereby reducing concern over amplicon contamination. This workshop will focus on technical aspects of SDA and homogeneous detection together with the workflow benefits associated with the BDProbeTec ET system. Plans will also be revealed to extend the utility of the instrument beyond the current menu of tests for Chlamydia trachomatis and Neisseria gonorrhoeae. Homebrew applications employing manufacturer-qualified Analyte Specific and General Purpose Reagents will be discussed together with a novel universal probe detection format.

BIO-RAD LABORATORIES - Linked Linear Amplification (LLA): A New Method for the Amplification of DNA

Linked Linear Amplification (LLA) is a new nucleic acid amplification method that uses multiple cycles of primer extension reactions. The use of primers that contain non-replicable elements render primer extension products unusable as templates for further amplification and results in linear accumulation of products. Through the use of nested primers, linear reactions can be "linked" resulting in total amplification yields comparable to those obtained by PCR. The unique composition of LLA products results in carry-over amplification efficiency that is lower by several orders of magnitude compared to PCR.

GENTRA SYSTEMS - Automated Nucleic Acid Purification for Large Sample Volumes

Continued advancements in the field of molecular pathology have resulted in a major increase in the demand for high quality nucleic acid purification. This increased demand has resulted in a sample preparation bottleneck and an emphasis on the development of new technologies to automate the purification process. Large samples are especially problematic in this regard as there are relatively few suitable methods available. Gentra has addressed this problem by developing the AUTOPURE LS, an instrument capable of high-throughput sample purification from large samples up to 10 mL in size. In a workshop format, Gentra will describe sample processing on the instrument and present data obtained from clinically relevant samples.

INTERGEN - A New Molecular Detection Technology for Gene Amplification

The workshop will provide an understanding of a new, patented technology from Intergen Company, Amplifluor molecular detection. Amplifluor is a closed-tube fluorometric detection format applicable to quantitative PCR and other primer-based nucleic acid amplification systems. This technology allows rapid, reproducible high throughput quantitation of nucleic acids without post-amplification manipulation, e.g., gels. Amplifluor eliminates the need to purify the amplified product before detection or quantification. The technology is applicable to real-time and endpoint instrumentation, as well as the exciting potential for multiplexing for simultaneous determinations. The workshop will provide the audience with: a brief description of this novel molecular detection technology; an appreciation for how it compares to currently used detection probe methods; the improvements it offers when applied to infectious disease testing in the laboratory; and applications to contemporary genetic analysis, SNPs and pharmacogenomics.

InVivoSCRIBE TECHNOLOGIES - Standardized Commercial Assays for Hematopathology Testing

This Hematopathology workshop will provide an overview and step by step instructions for our standardized commercial PCR assays (NOTE: our assays require purchase of Taq polymerase and the license to practice PCR from third parties). All of our assays use the same basic protocol and thermocycler program. These standardized assays have been thoroughly validated and are currently being used for hematopathology testing to identify leukemias, lymphomas and clonal cell populations by leading university medical centers and molecular diagnostic and reference laboratories. Assays covered in this workshop will include: B cell, T cell and B & T cell clonality assays; bcl-2 and nested bcl-2 assays, bcr/abl and APL RT-PCR Assays. The workshop will cover the performance characteristics, as well as controls and safeguards built into these standardized assay testing kits. We will discuss the three basic testing formats as well as strategies for increasing throughput and eliminating subjective visual analysis of agarose and polyacrylamide gels.

NANOGEN - Nanogen's NanoChip Molecular Biology Workstation Workshop

This workshop will include a description and demonstration of the NanoChip system. Nanogen has developed a microelectronic chip-based assay system for single nucleotide polymorphism (SNP), short tandem repeat (STR) and other nucleic acid mutation analyses. The 99-test chips are customized (home-brewed) in the user's lab with the NanoChip Loader. Patient samples are then processed on the NanoChip Reader. Data from multiple external users will be presented showing the system to be 100% accurate, correcting 6% to 11% of results from DNA sequencing and RFLP. High precision gene expression will be available in the near future and preliminary data will be shown.

PROMEGA CORPORATION – READIT - A Novel Technology for SNP Genotyping

The READIT technology is capable of detecting a wide variety of sequence variations including SNPs, insertions, deletions and chromosomal translocations. The READIT technology is also capable of multiplexed PCR and RT-PCR product detection in a high-throughput, arrayed plate format.

QIAGEN - Sample Stabilization and Processing for Molecular Diagnostics, Biochip Arrays and SNP Analysis

QIAGEN is pleased to offer a new technical workshop on tools and techniques to improve molecular diagnostic assays. We will review current and emerging applications such as SNP analysis, Biochip arrays, PCR, RT-PCR and sequencing. Sample stabilization and transport processes with a focus on RNA will be presented.

ROCHE MOLECULAR BIOCHEMICALS - The LightCycler System for Molceular Pathology

Roche Molecular Biochemicals has developed an integrated system which performs nucleic acid isolation, PCR, and both qualitative and quantitative sample analysis. The MagNA Pure LC instrument performs totally automated isolation of DNA, total RNA, and mRNA from a variety of sample types. Additionally, the MagNA Pure LC can be programmed to automatically assemble the purified samples into biochemical reactions, e.g., PCR, restriction enzyme digests. The LightCycler instrument is a very rapid thermocycler which utilizes real-time analysis of the PCR kinetics within each sample. The LightCycler System is currently used in pathology labs in the U.S., Europe, and Japan for genotyping, analysis of neoplastic tissue, and identification of pathogens. This workshop provides an overview of the MagNA Pure LC and LightCycler Systems.

STRATAGENE - Introduction to Real-Time PCR Analysis and Allelic Discriminaton Using Molecular Beacons.

Participants will be introduced to the concept of real-time PCR analysis. This will be compared and contrasted to end-point detection of PCR products. A review of current instrumentation platforms (real-time and end-point detection) will be described and a demonstration of one platform will be given. The workshop will include a description of molecular beacon detection assays for allelic discrimination of human polymorphisms, such as MTHFR and Factor V_Leiden. A molecular beacon format will be shown for the detection of infectious disease agents, such as herpes simplex types 1 and 2. Assay development considerations such as throughput, specificity and sensitivity will be described.

Educational goals:

• participants will understand fluorescent detection using molecular beacon probes
• assay development considerations using molecular beacons will be reviewed
• potential applications of the detection technology in the clinical research laboratory will be reviewed

THIRD WAVE TECHNOLOGIES, INC. - Invader Technology- Endpoint and Real-Time Applications for Hemostasis, Viral & Genetic Disease Analysis

This technical workshop seminar will cover the following information:

• The Invader technology, our novel platform for quantitative and qualitative analysis of specific DNA or RNA species in complex mixtures, without prior target amplification.
• Examples of both real time and end point analysis using a homogeneous detection method based on fluorescence resonance energy transfer (FRET).
• Specific applications include hemostasis (Factor V_Leiden, Factor II, MTHFR, HR2), ApoE (non-AD), virology (HBV, CMV) and other SNP applications.

Participants will be given a foundation for the practical understanding of this technology platform and its many applications in research and in the clinical molecular laboratory.

VISIBLE GENETICS - HIV Resistance Testing

The science and technology behind HIV resistance testing will be discussed as well as the various methods available to perform this testing. Clinical relevance will be presented together with appropriate case histories. Information and data will also be provided on the TRUGENE HIV-1 Genotyping kit, the OpenGene automated DNA Sequencing System, TRUGENE software and the Vigilance II study.

VYSIS - FISH: A New Mainstream Molecular Pathology Tool for Analysis of Breast, Bladder, Prostate and Hematological Cancers.

DNA probe technology using Fluorescence in situ Hybridization (FISH) has evolved into a mainstream tool for the Pathologist and Cytopathologist. FISH is used to detect chromosome, gene and locus copy changes in paraffin-embedded and cytological preparations from a variety of solid tumor and hematological samples. Using Vysis modular automation systems FISH tests are easily adapted into the routine workflow of the pathology and cytology laboratory. Reimbursement is also readily available for these tests. This symposium will discuss FISH technology, its integration into the Pathology laboratory and application of specific tests - PathVysion HER-2 and UroVysion Multi-color Probe Mixture to detect gene and chromosomal changes associated with cancer and cancer therapies.

AMP would like to acknowledge the following exhibitors at the Sixth Annual Meeting:

• Abbott Laboratories
• Ambion, Inc
• Baylor College of Medicine/Medical Genetic Laboratories
• Becton Dickinson
• Bio-Rad Laboratories
• Chemicon International, Inc
• Dako Corporation
• GeneTests: Genetic Testing Resource
• Genetic Information Management Systems, Inc
• GenoVision Inc
• Gentra Systems, Inc
• Innogenetics
• Intergen Company
• NCCLS
• Nanogen, Inc
• Organon Teknika
• PE Biosystems
• PreAnalytix
• Promega Corporation
• QIAGEN, Inc
• Roche Lab Systems
• Roche Molecular Biochemicals
• Roche Molecular Systems
• Stratagene
• Third Wave Technologies, Inc
• Visible Genetics, Inc
• Vysis, Inc

The AMP is delighted to announce that Clinical Micro Sensors (Pasadena, CA), a wholly owned division of Motorola, has generously offered to sponsor awards for the 3 best abstracts submitted by trainees at the Annual Meeting this year, as well as in 2001 and 2002. The awards include a cash prize of $1250 and a commemorative trophy for each winner. AMP gratefully acknowledges this generous award from CMS.

There are 16 eligible abstracts submitted this year. The award will be presented to the winners at the Business Meeting on Saturday. CMS will sponsor a reception for the winners after the business meeting and all AMP meeting attendees are welcome to attend.

To be eligible, an abstract must be submitted for presentation at the annual meeting by an Associate Member who must be the primary author of the work. All eligible abstracts will be reviewed by members of the Training and Education Committee which will select the best 3 abstracts. Abstracts will be judged without regard to category of content, i.e., basic vs. applied or subdivision.

-Anthony E. Killeen, MD, PhD

Chair, Training and Education Committee

e-mail: akilleen@umich.edu

The Clinical Practice Committee (CPC) has continued to work on the same constellation of issues listed in the May 2000 Newsletter. For some the developed positions were adopted by Council and official AMP responses submitted to the relevant agencies, while other initiatives are still ongoing.

HHS Secretary's Advisory Committee on Genetic Testing. Despite close similarity to the College of American Pathologists position statement and our frequent communication with CAP's Government and Professional Affairs office, it was ultimately decided that AMP furnish its own independent response to the Preliminary Recommendations of this government-appointed committee charged with examining needs for increased oversight of genetic testing. Our position expressed concern over SACGT's broad definition of genetic tests, the proposed uniform requirement for specific informed consent for all predictive genetic tests (and eventually other types as well) with the laboratory serving as gatekeeper, and the enhanced role for FDA in oversight of in-house ("home brew") test procedures. We also made reference to our endorsement of the CAP position.

Centers for Disease Control/CLIAC Notice of Intent. The CPC and Council also worked hard to develop an AMP response during the public comment period concerning proposed changes to CLIA regulations in the area of genetic testing put forth by the CLIA Advisory Committee. Some of our concerns were similar to those for SACGT, though CLIAC defines genetic tests even more broadly, to include molecular tests for somatic mutations as well. Another concern unique to the CLIAC NOI was over proposed restrictions on re-use of clinical samples for quality control purposes. The AMP response this time did not specifically endorse the CAP response, even though the positions were again quite similar. In addition, the CPC had opportunity to examine the official responses of a number of other clinical laboratory organizations, including ACLPS, AABB and AACC; although developed entirely independently of ours and CAP's, all the position papers were remarkably similar in their points of concern and the overall tenor of the language addressed to CDC/CLIAC.

CDC Genetic Testing Laboratory Forum. The CPC continues to monitor and provide input to this government-professional consortium that meets every few months, and consulted with President-Elect Karl Voelkerding who has been representing AMP at these meetings. The group is currently attempting to develop a hierarchical classification of genetic tests which would aid SACGT and FDA in deciding which ones might require increased regulatory oversight.

AMP Test Directory. The previous Newsletter provided background on a proposal the CPC is exploring to incorporate the AMP Test Directory into the federally-funded online database of genetic testing laboratories, GeneTests. Over the summer Fran Pitlick, Rick Press and I visited GeneTests' headquarters in Seattle to learn more about the logistics and desirability of merging the two databases. The GeneTests group was very enthusiastic about having our members' laboratories listed, though there are a number of tricky practicalities that would need to be worked out. Genetic tests in the AMP Directory could be incorporated immediately and at no cost to AMP, while other categories would require additional work on database management and possibly some external funding. As we have stated before, AMP members would be able to opt out of this joint listing if they so choose, though we anticipate many would welcome the enhanced international exposure it would provide for their services. In order to get a better handle on the members' wishes and the format of searches they would prefer in such a directory, a survey has been sent out via CHAMP. We encourage the members to provide input to the CPC in this way so that any decision we make will be in the best interests of the organization. We also plan some informal briefings on this subject for the various subdivisions at the Denver meeting.

CDC Request for Proposals. Both the AMP CPC and some individuals within CAP had considered responding to an RFP recently issued by CDC which was aimed at collecting epidemiologic data on the effectiveness and appropriate use of genetic tests and genotype-phenotype correlations for model genetic diseases. However, neither group felt it had the resources to coordinate such a multi-center effort within the short timeframe required. Instead, an application sponsored jointly by the Association of American Medical Colleges and the American College of Medical Genetics was submitted with consultation from a number of AMP members and an official letter of collaboration from AMP stating our willingness for members to serve on the disease-specific working groups that will be set up. More information on this project will be forthcoming in the event it is funded.

- Wayne W. Grody, MD, PhD

Chair, Clinical Practice Committee

e-mail: wgrody@mednet.ucla.edu

The Infectious Diseases Workshop I will be an interactive discussion of the NCCLS document "Quantitative Molecular Methods for Infectious Disease." The overall goal of the workshop is to obtain input from the end users of the document. We are interested in obtaining feedback to avoid overinterpretation or misinterpretation of the guideline. Many members of the committee including the Chairperson, Roberta Madej, will be present as participants on the panel. The plan is to discuss specific topics from the document that will be of particular interest to the group. The goal is to obtain feedback that can be incorporated into the document. We are providing a list of topics for discussion, and request that members review these topics prior to the meeting, so we can have a productive exchange of ideas. The topics for discussion are listed here:

1. Use of independent controls: With what types of tests should independent controls (in addition to kit controls provided by the manufacturer) be used? FDA cleared/approved commercial assays, commercial assay used as "research use only", and/or in-house developed assay?

If independent controls are used, what is appropriate control material; vendor supplied, e.g., WHO HCV calibrator, synthetic (cloned) material, spiking normal plasma with clinical specimen or plasmid, use of previously run clinical specimen?

How many and how often should the controls be run? Should one or multiple (low and high) controls be used? Should independent control(s) be run on each shipment, each lot, each week, each run, each month?

If independent controls are used, how should the concentration (viral load) determined? Based on information provided by the manufacturer, running replicates (2, 4, 8, or 20?) and determining the mean? What is the acceptable range of values +/- 2 or 3 SD?

If manufacturer control is out of range and the independent control is in range, is the run valid?

2. Proficiency testing: The CLIA regulations of HCFA-certified proficiency are stated at 3 events per year with 5 challenges per event. Currently, this is available for HIV viral load testing only. What is an appropriate alternative for other analytes? How often, how many samples, what to use as material?

3. Clinical verification: How should individual laboratories do a clinical verification for quantitative testing? How many specimens should be included in clinical verification? Does this needs to be done for each indication of testing (i.e.-monitoring response to therapy, assessing prognosis)? Can the individual lab be responsible for this process? For example HCV quantitation, are labs required to perform a clinical verification?

4. Results reporting: Quantitative tests for infectious diseases report values that span several logs. Values will not be normally distributed, which are the first criteria for statistical calculations. Data should be log-transformed before QC calculations and for reporting of patient’s results. Do laboratories routinely do this?

Quantitative assays have both a limit of quantitation and a limit of detection. How do you report values below the limit of quantitation but above the limit of detection?

How do labs report values for assays that have been standardized against a "standard?" Is the standard referenced in the report?

5. Real time PCR: Real time PCR offers the ability to quantitate nucleic acid without the use of an internal calibrator or external standard curve. The assay is verified with an internal calibrator or standard curve. Subsequent runs can be done without a standard curve or internal calibrator provided that the amplification efficiency of the geometric phase of amplification approaches 100%. Is this appropriate or should calibrators or standard curves continued to be required?

Do the guidelines address concerns about quantitative methods using "real-time" PCR methods?

-Angela M. Caliendo, MD, PhD, Subdivision Chair

e-mail: acalien@emory.edu

One to three percent of the world’s population is affected by epilepsy at some point in their life, making it the commonest of the neurological disorders. Epilepsy, which can be thought of as the result in an imbalance between the excitatory and inhibitory stimulation of the nervous system is characterized by recurrent seizures which represent a disturbance of neuronal synchrony. Epilepsy can be symptomatic (acquired) i.e., of known cause or idiopathic, i.e., of unknown origin. Epilepsy can be further divided into partial when the lesion has limited localization or generalized when more widespread.

Only about one percent of epilepsy has a straight forward Mendelian mode of inheritance, though this includes more than 200 Mendelian disorders. For example 25% of Fragile X syndrome and more than 90% of Angelman syndrome patients have epilepsy. Tuberous sclerosis and neurofibromatosis also have epilepsy as part of their phenotype, whilst 10% of Alzheimer’s disease patients develop seizures. All modes of inheritance including chromosoma, e.g., 5-10% of Down syndrome patients and mitochondrial, e.g., MEERF, MELAS, have been observed, but by far the commonest mode of inheritance is complex.

Between 40 and 50% of epilepsies are idiopathic generalized epilepsies (IGE) which are a group of disorders with a genetic basis defined by their age-related onset, clinical and electroencephalographic characteristics. A major challenge is the identification of the susceptibility genes for these common familial epilepsies. Whilst most epilepsies are thought to have a complex inheritance, the genes involved in some of the rarer forms are beginning to be identified. Most of these genes are turning out to be ion-channel subunit genes, for example Benign familial neonatal convulsions (BFNC) can result from mutations in KCNQ2 a voltage-gated delayed rectifying K+ channel on 20q13.2 or KCNQ3 on 8q24. Autosomal dominant nocturnal frontal lobe epilepsy (ADNFLE) can result from mutations in CHRNA4 the alpha 4 subunit of the nicotine acetylcholine receptor gene also at 20q13.2. Interestingly KCNQ2 and CHRNA4 are only 30 kb apart. Similarly, a mutation in SC1B, a voltage-gated sodium channel beta 1 gene results in febrile seizures and generalized epilepsies (GEFS).

An interesting exception to the finding that human epilepsies being "channelopathies" was the finding in Progressive myoclonus epilepsy of Unverricht-Lundborg type which is due to mutations in the Cystatin B gene, a cysteine protease inhibitor. Most interestingly the common pathogenic alleles were expansion of a dodecamer minisatellite in the five prime promoter region. Another mechanism is exemplified by Lafora body disease, this myoclonus epilepsy progresses to ataxia and dementia. Lafora disease, which is characterized by PAS-positive cytoplasmic inclusion bodies in brain, muscle, iver and skin, is due to mutations in laforin, an intracellular protein tyrosine phosphatase.

As the molecular etiologies of epilepsy are elucidated it should be possible to design better anti-epileptic drugs. Similarly as the genetics of epilepsy becomes clearer no doubt we will see the development of an "epilepsy-genechip" leading to improved diagnosis and treatment.

References.

• Gardiner RM. Genetic basis of the human epilepsies. Epilepsy Research 36: 91-95, 1999.
• Prasad AN et al. Recent advances in the genetics of epilepsy: insights from human and animal studies. Epilepsia 40(10):1329-1352, 1999.
• Gardiner RM Impact of our understanding of the aetiology of epilepsy. Neurol. 247:327-334, 2000.

-Antony E. Shrimpton, PhD, Subdivision Chair

e-mail: shrimpta@mailbox.hscsyr.edu

Recent advances in the Human Genome Project, laboratory automation and bioinformatics have opened many new territories to scientific investigation. For example, some investigators are trying to use the new tools to understand the genetic origins of cancer. But the tsunami of information and avalanche of opportunity can be dizzying, and a little bit of history may provide some helpful guidance in this brave new world.

Classical epidemiology has excelled at detecting environmental carcinogens including tobacco, asbestos, vinyl chloride, aniline dyes, radium and many others. Most are potent mutagens, and the study designs centered on collecting exposure and outcome data, but genetic features were neither available nor needed. For example, the early studies of lung cancer in the 1950's considered several environmental causes, but excess cases occurred consistently among smokers, and a dose-response was later demonstrated. Now that most powerful carcinogens have been removed from public spaces, and other improvements have extended lifespans, new problems have emerged.

Today's challenges include the origins of cancers of the breast, prostate and colon, and progress has been slow, despite the best efforts of dedicated investigators. One reason for the impasse is that the relevant environmental factors seem to be subtle and complex matters of diet and lifestyle that have been hard to measure. For example, an hypothesis linking dietary fat intake to breast cancer has been debated for decades, yet two major studies clashed over it again last year. Misclassification error is a likely explanation for the continued controversy since exposure assessment is problematic. Meanwhile, modern genetics and laboratory technology have been hailed as saviors, and substantial resources have been allotted to investigations of gene-environment interactions in cancers of the colon, breast and prostate.

In many ways, lung cancer is an over-looked scientific opportunity. Fifty years of epidemiologic investigations have quantified lung cancer risks according to tobacco consumption, gender and ethnicity. In 1999, lung cancer produced an estimated 158,900 American deaths, and it was the leading cause of cancer mortality for women and men in developed nations. Unlike most other western malignancies, the major cause of lung cancer is known: exposure to tobacco smoke produces about 90% of cases. It is tragic that mass-production and marketing of cigarettes produced the largest human carcinogenesis experiment in recorded history. And it is ironic that only one or two in ten persistent smokers ever develops lung cancer despite daily doses of potent carcinogens. This fact suggests that smoking is more a "stress test" for cancer susceptibility than an inevitable carcinogen. The implications are that genetic susceptibility determines much of a smoker’s risk of lung cancer, and that genetic resistance may protect half of smokers from their mortal habit.

Genetic markers identifying susceptible individuals will be valuable intellectual property useful for genetic testing and discovery of drugs for cancer prevention. But little of the lung cancer risk conferred by smoking can be explained by known polymorphic variants. However, recent data indicate that isoforms of Phase I and II detoxification enzymes modulate risks among individuals exposed to low levels of tobacco smoke. For example, a study of non-smokers showed that passive smoking and homozygous deletion of glutathione S-transferase M1 (GSTM1), a detoxification enzyme, conferred a significant excess risk of lung cancer. In addition, a few reports indicate that common variants of cytochrome p450 1A1 (CYP1A1) and GSTM1 affect risks for "light" but not "heavy" smokers.

These and other observations suggest the hypothesis that non-smokers and "light" smokers who develop lung cancer are genetically predisposed. If this is true, then strategies for discovering cancer susceptibility alleles can be made more efficient by comparing genetically prone individuals to those who are constitutionally impervious. In addition to metabolic enzymes that activate and detoxify carcinogens in tobacco smoke, it is likely that variants of DNA repair enzymes, DNA damage response proteins and cell cycle regulators modulate cancer risks. Furthermore, polymorphisms conferring susceptibility to lung cancer have been relevant to cancers of the colon, breast and prostate tumors whose environmental causes are largely unknown. Additionally, dietary habits, chronic inflammation, family history, radiation and occupational exposures substantially modulate lung cancer risks among smokers. This suggests that allelic variants which cooperate with dietary fat intake to enhance lung cancer risks could be tested for similar effects in breast cancer patients. Similarly, variants which interact with dietary heterocyclic amines in lung cancer patients could be examined for relevance to prostate cancer. In addition, the complexity of tobacco smoke scores of chemical carcinogens, reactive oxygen and nitrogen species plus a radioactive element is an advantage since this complex mixture may reveal many forms of genetic susceptibility. Finally, the Human Genome Project has discovered thousands of new variants that await testing for relevance to cancer susceptibility. Lung cancer is an attractive model for screening the new genetic data for useful markers because the major environmental exposure is readily quantified, and genetic susceptibility or resistance eventually becomes evident among persistent smokers.

-William P. Bennett, MD, Subdivision Chair-elect

Annual Meeting Plenary Speakers

The annual meeting is now just around the corner. I am looking forward to hearing the two excellent speakers now scheduled for the Hematopathology Plenary Session. As mentioned in the previous newsletters, Lawrence M. Weiss, MD, Chair of the Division of Pathology, City of Hope National Medical Center will speak on the Role of the Epstein Barr Virus in Malignancies. Unfortunately, the other originally scheduled Hematopathology Plenary session speaker, Dr. Pandolfi, will not be able to attend the Denver meeting. We are very fortunate, however, to have James Downing, MD, Chair of the Department of Pathology and Laboratory Medicine, St. Jude Children’s Research Hospital as a Plenary speaker. Dr. Downing is a recognized international expert in the molecular biology of leukemias and will speak on the Core Binding Factor Leukemias. Both Dr. Weiss and Dr. Downing are long-time AMP members, and the fact that we can recruit such excellent speakers from our own ranks speaks highly of our society.

Workshop Update

All hematopathology subdivision members should have received (and hopefully returned) the survey distributed by Dr. Janina Longtine, Brigham and Women’s Hospital, entitled Current Practice of Q-PCR and Minimal Residual Disease Testing. The results of this survey will be reviewed as part of the Hematopathology Workshop moderated by Adam Bagg, MD, Hospital of the University of Pennsylvania. This workshop will address many of the questions that are in all of our minds regarding the implementation of this type of testing in our laboratories.

The sample exchange workshop will focus on J_H/bcl-2 and bcr-abl testing. Both sets of samples are now distributed, and the results of J_H/bcl-2 are now due. Rita Braziel, MD, Oregon Health Sciences University, has organized this exchange and will accept any results right up to the beginning of the meeting. However, the earlier you return your results, the more information we will have to present in the workshop.

It is shaping up to be a great meeting and I look forward to seeing you all in Denver.

-Daniel A. Arber, MD, Subdivision Chair

e-mail: darber@coh.org

We want to thank all of the AMP members who participated in the Quality Control Survey for the AMP 2000 meeting. 41 groups completed the survey and the results will be presented at the Technical Topics Panel discussion, Friday, November 10, 2000 at the AMP meeting. Conference participants are urged to join the panel in a discussion of controls, contamination control, test validation, proficiency testing, specimen acceptability, and IRB policies. The survey summary will be provided at the panel discussion. We hope the panel will provide a helpful forum for the comparison of quality control issues of interest to the various molecular laboratories represented in AMP and members of the conference.

Medical Technology Selected Technical Topics will also present a "Comparison of Methods for Real Time PCR". The talks will be on Thursday afternoon of the AMP meeting and will be presented by Anami Patel, PhD and Elaine Lyon, PhD.

-Barbara Griffith and Kent Williams

Technical Topics Program Committee

An interesting thing about revolutions is that they are sometimes not obvious until they are over. I’ve been through two that have changed the face of our profession and laboratory testing. The first was the decision by NIH to cease funding research focused toward developing analytical methodology for clinical diagnostics. This granting mechanism paid for my graduate education; I made it though just as the door was closing. This bygone era is commemorated by the AACC’s "Oak Ridge Conference" reflecting the days when the NIH funded program at Oak Ridge National Laboratory was spearheading the development new instrumentation for clinical diagnostics. Today, such research is the exclusive domain of industry.

A second revolution was the introduction of the Diagnostic Related Group (DRG) as the model for reimbursement under Medicare. Prior to the mid-1980’s, clinical laboratories acted as profit centers or helped to offset revenue negative departments within not-for-profit medical centers. Laboratories adopted what they believed was the best technology and passed on the cost to the consumer. The DRG system set in motion a process that changed the way laboratory services were provided, ultimately leading to the consolidation and growth of larger commercial and not-for-profit laboratories. It changed my career along with many others.

One of the possible outcomes of the CLIAC and Secretary of HEW Committees’ deliberations on genetic testing is a requirement for FDA approval of home-brew genetic tests. The proposed process has been compared to the 510k-approval process for Class II diagnostic devices. Should this come to pass, I predict the outcome will be nothing short of a revolution that will change the practice of molecular pathology. It will be the first breach of the barrier that has kept FDA regulators focused on industry and clinical practice in the hands of medical professionals. The FDA has long held that laboratories that produce home-brew assays are medical device manufacturers; but have been held at the gate by fierce opposition from the medical community. We now appear to be opening the doors and inviting the FDA in. Do you know what is required to submit a 510k? Talk to colleagues in industry and find out how many people, how much money and how much time it takes to submit a 510k or PMA application for a new genetic test. Think carefully about who will have the resources to make such applications and where genetic testing will be performed. Think about where you and your lab will fit into this new world. Make your feelings known before the revolution is over and the die is cast.

-Richard S. Schifreen, PhD, Business Unit Leader

Molecular Diagnostics, Promega Corporation

In a letter dated August 8^th, OSI Pharmaceuticals stated the following: In December 1999, OSI Pharmaceuticals, Inc. sold the diagnostic product business to the Bayer Corporation. As a result, OSI no longer has a manufacturing and sales business. Our attempts to find a company to take over the TransProbe-1 product have not been successful. OSI Pharmaceuticals is planning to discontinue the sale of our TransProbe-1 product as or January 2001. The lot that we are currently selling expires in February 2001. It is our belief that alternative methods and/or products can substitute for this product (cytogenetics, PCR analysis, FISH). If you need assistance in identifying alternatives or have the need for additional information, we would appreciate you contacting us by September 15^th so that we can provide you this information in a timely manner. OSI Pharmaceuticals would like to thank [its customers]. We remain committed to providing customer support for as long as we sell the TransProbe-1 kit.

The letter gives OSI contact information as 106 Charles Lindbergh Blvd., Uniondale, NY 11553-3649. 516.222.0023 (phone); 516.222.0114 (Fax).

Ed. Note: Thanks to AMP member, Ray Tubbs, for supplying this information for the Newsletter.

Clinical Micro Sensors (Pasadena, CA), a DNA chip company founded by AMP member, Jon Faiz Kayyem, PhD, based on technology he developed during his postdoctoral work in the laboratory of Dr. Tom Meade at the California Institute of Technology, was acquired on June 23, 2000 by Motorola, a Fortune 100 company headquartered in Schaumburg, IL.

Clinical Micro Sensors is a leader in the field of mass applied genomics -- the widespread application of genetic knowledge to medicine and industry. CMS is developing DNA detection units and disposable biochip cartridges, combining universal platform design and advanced bioelectronic technology. CMS eSensor™ technology is poised to set new standards for rapid, cost-effective DNA analysis in healthcare, agriculture, food safety, animal health and breeding, and environmental monitoring.

Motorola and CMS first entered into a technology alliance in April of 1999, which included an initial equity investment by Motorola. The two companies have been working closely since that time on product development. In acquiring CMS, Motorola exercised an option to buy CMS that was part of the earlier alliance. Both CMS and Motorola are excited about the acquisition, as it will accelerate delivery of advanced CMS products to the marketplace. The product lines for CMS and Motorola's BioChip Systems business are complementary and both companies bring important patents and alliances to the relationship. Together CMS and Motorola plan to offer a complete range of customer solutions. CMS will operate as a division of Motorola’s Future Business organization and will continue to be managed by its current executive team.

-Daniel H. Farkas, PhD, HCLD, FACB

Director of Clinical Diagnostics

Motorola’s Clinical Micro Sensors Division

e-mail: dan.farkas@motorola.com

Daniel H. Farkas, PhD, HCLD, Director of Clinical Diagnostics at the Clinical Micro Sensors Division of Motorola was recently selected by the FDA’s Center for Devices and Radiological Health to be the sole industry representative on the recently established Molecular and Clinical Genetics Panel of FDA’s Medical Devices Advisory Committee.

This is the first FDA panel created for molecular genetic diagnostics and the panel is charged with advising the FDA Commissioner on molecular and clinical applications for new DNA-based genetic testing devices. The members will provide advice on the appropriate scientific criteria to use in approving diagnostic tests for human genes and also will recommend classification of tests for human genes.

"As the Molecular and Clinical Genetics Panel becomes involved in evaluating devices from the rapidly developing area of molecular diagnostics and genetic tests, Dr. Farkas’ scientific expertise combined with his understanding of the molecular diagnostics industry will be an invaluable asset to the Panel," said Peter E. Maxim, PhD, the Executive Secretary of the Panel.

Dr. Farkas was nominated by both the AMP and the American Association for Clinical Chemistry (AACC) and was selected from among fifteen nominees to be the industry representative to this panel, joining several other AMP members on the panel, including Drs. Walter Noll and Gregory Tsongalis. Before joining CMS in 1998, Dr. Farkas was co-director of the Molecular Probe Laboratory in the Department of Clinical Pathology at William Beaumont Hospital (Royal Oak, MI) and Section Chief of Diagnostic Molecular Pathology in the Department of Pathology at St. Barnabas Medical Center (Livingston, NJ). Dr. Farkas has served AMP on its Clinical Practice Committee, as Secretary-Treasurer and as the AMP Newsletter Editor for the last five years.