WEDNESDAY, NOVEMBER 12th

8 am-5 pm: Corporate Sponsored Workshops
Evening: AMP Committee Meetings

THURSDAY, NOVEMBER 13th

7-8:30 am Registration/Continental Breakfast
7:55 am Introductory Remarks, Rita M Braziel, MD, Oregon Health Sciences University

8-10 am SOLID TUMORS PLENARY SESSION

Moderator-Sandra Wolman, MD Uniformed Services University, Bethesda, MD

• DNA Methylation Changes & Cancer. Peter Jones, MD, USC/Norris Cancer Center, Los Angeles, CA
• Effects of DNA Methylation on Formation of DNA Adducts. Gerd Pfeifer, PhD, City of Hope Medical Center, Duarte, CA
• Two-Dimensional Genome Scanning of Human Gliomas. Joseph F Costello, PhD Ludwig Institute for Cancer Research La Jolla, CA
• Mismatch Repair Deficiency: A Clue to Hypermethylation in Cancer? Jean-Pierre Issa, PhD Johns Hopkins Oncology Center Baltimore, MD

9-11 am Review Course for Medical Technologists' National Certification Agency Exam in Clinical Molecular Biology

Moderator-Daniel Farkas, PhD, HCLD

Presenters: Richard DiCarlo, MT (ASCP) Ann Drevon, MT, (ASCP) William Beaumont Hospital Royal Oak, MI

10-11 am Break/Visit Posters/Exhibits (Posters Attended)

11 am-12 noon ABSTRACT PLENARY SESSION
Platform Presentation of Best Meeting Abstracts
Moderators - Rita M Braziel, MD Margaret Gulley, MD University of Texas at San Antonio

12-1 pm Lunch

12:10-1 pm Hematopathology Section Luncheon Meeting

1-3 pm GENETICS PLENARY SESSION

Moderator-Ronald McGlennen, MD University of Minnesota, Minneapolis, MN

• Molecular Genetics of Craniosynostosis Maximillian Muenke, MD Children's Hospital of Philadelphia Philadelphia, PA
• Hemochromatosis: Clinical and Laboratory Aspects Richard Press, MD, PhD Oregon Health Sciences University Portland, OR

3-4 pm Break/Visit Posters/Exhibits (Posters Attended)

4-6 pm WORKSHOPS-SESSION A

INFECTIOUS DISEASES WORKSHOP I
Topic: Infectious Diseases Proficiency Testing Programs-Progress & Lessons Learned
Moderator-Roberta Madej, MT,MS, MBA Chiron Corporation, Emeryville, CA

• CAP-Dave Persing, MD, PhD Mayo Clinic, Rochester, MN
• HCV (Eurohep)/M. tb (Netherlands Public Health Laboratory) Rick Nolte, PhD Emory University, Atlanta, GA
• HSV - Danny Wiedbrauk, PhD William Beaumont Hospital Royal Oak, MI

SOLID TUMORS WORKSHOP I
Topic: New and Emerging Tests
Moderator-Thomas Frank, MD Myriad Genetics, Salt Lake City, UT

• Non-invasive Cancer Diagnosis by Detection of Anomalous CD44 Gene Expression David Tarin, MD Director, University California-San Diego Cancer Center
• Microdissection as a Tool for Molecular Diagnosis. Michael Emmert-Buck MD PhD, NIH, Bethesda, MD
• BRCA1 in Breast Cancer. Thomas Frank, MD
• Are all p53 Mutations Detected in Fixed Tissue Real? Mehrdad Nadji MD University of Miami, Miami, FL

6-7:30 pm Welcoming Reception

FRIDAY, NOVEMBER 14th

7:30 am Continental Breakfast

8-10 am HEMATOPATHOLOGY PLENARY SESSION

Emerging Technologies: Future Clinical Applications in Hematopathology Molecular Diagnostics.

Moderator-Rita M. Braziel, MD

• Use of cDNA Micro array Technology for Assessment of Gene Expression Patterns in Normal & Neoplastic Cells Douglas Ors, MD, PhD. Walter V & Dun Berry Fellow Stanford University, Stanford, CA
• Automated Spectral Karyotyping in Leukemias and Lymphomas Thomas Ried, MD. NIH, National Center for Genome Resources, Bethesda, MD

10-11 am Break/Visit Posters/Exhibits

11-NOON AMP Membership Business Meeting

NOON-1 pm Lunch

12:10-1 pm Genetics & Infectious Diseases Sections Luncheon Meetings

1-3 pm WORKSHOPS-SESSION B

GENETICS-WORKSHOP I
Topic: Practicum in Sequence Based Mutational Analysis for Clinical Testing
Moderator-Ronald McGlennen, MD, Univ of Minnesota, Minneapolis, MN. Speakers To Be Announced

HEMATOPATHOLOGY WORKSHOP I
Topic: How Not to Reinvent or Spin Wheels: Practice Guidelines for Test Protocols, Quality Assurance, and Reporting (I)
Moderators-Tim O'Leary, MD, PhD Armed Forces Institute of Pathology Washington, DC Adam Bagg, MD Georgetown Univ., Washington, DC

3-4 pm Break/Visit Posters/Exhibits (Posters Attended)

4-6 pm WORKSHOPS-SESSION C

GENETICS-WORKSHOP II
Topic: A Minisymposium in Cardiovascular Genetics
Moderator-Ronald McGlennen, MD

• Interface with Genetic Counseling
• Sifting Through the Mountain of Chemical and Genetic Test Data
• Working Towards Testing Algorithms for Hyperlipidemias, Predisposition to Cardiomyopathy, Familial Hypertension, and Thrombosis

INFECTIOUS DISEASES-WORKSHOP II
Topic: HIV-Beyond Viral Load Testing
Moderator - Rick Nolte, PhD Emory University, Atlanta, GA

• Antiviral Resistance. Scott Eastman, PhD, Chiron Corporation, Emeryville, CA
• Prognostic Indicators. Debra Leonard, MD, PhD, Univ of Pennsylvania, Philadelphia, PA
• Tests of Cure. Angela Caliendo, MD, PhD, Massachusetts Gen. Hospital, Boston

7-10 pm AMP Council Dinner Meeting (Current and Incoming Council Members)

SATURDAY, NOVEMBER 15th

7:30 am Continental Breakfast

8-10 am INFECTIOUS DISEASES PLENARY SESSION

Moderator Rick Nolte, PhD

• Microbial Pathogen Discovery: Who's Out There? David Relman, MD, VA Palo Alto Health Care System, CA
• Nucleic Acid Sequencing Studies of Microbial Pathogens. Jim Musser, MD, PhD Baylor College of Medicine, Houston

10-11:30 am Break/Visit Posters/Exhibits (Posters Attended 10-11)

11:30-12:30 pm Lunch

11:40-12:30 pm Solid Tumor Section Luncheon Meeting

12:30- 2:30 pm SPECIAL TOPICS PLENARY SESSION

Moderator-Cheryl Willman, MD University of New Mexico

• How to Maximize Reimbursement for Molecular Testing. Jeffrey Kant, MD, PhD, University of Pittsburgh
• Ethical Issues in Clinical & Research Studies Using Human Samples Mark Sobel, MD, PhD, Laboratory of Pathology, NCI, Bethesda

2:30-3 pm Break-Visit Posters/Exhibits

3-5 pm WORKSHOPS - SESSION D

SOLID TUMORS-WORKSHOP II
Topic: Presentation of Selected Abstracts
Moderator-Linda Wasserman, MD, University of California at SD

HEMATOPATHOLOGY. WORKSHOP II
Topic: How Not to Reinvent or Spin Wheels: Practice Guidelines for Test Protocols, Quality Assurance, and Reporting (II)
Moderators - Tim O'Leary, MD, PhD, and Adam Bagg, MD

5:30-7 pm AMP Farewell Reception

CHAMP HAS A NEW E-MAIL ADDRESS (champ@www2.pathology.pitt.edu)

CHAMP, AMP's electronic bulletin board for information, queries, messages & member interaction has migrated to new hardware & e-mail platforms. Some minor problems should be resolved soon, even if I have to learn Unix to deal with the server directly. A number of members are not currently on CHAMP. If you are not receiving CHAMP messages, we've either had technical problems with the old hardware/software platform, have an incorrect e-mail address for you (has it changed?), or you're not subscribed. PLEASE SUBSCRIBE NOW. I could add you administratively in Pittsburgh, but an advantage of subscribing yourself is that you will receive back a welcoming message with additional instructions on how to use CHAMP.

HERE'S HOW TO SUBSCRIBE TO CHAMP: Send an e-mail message to: listserv@www2.pathology.pitt.edu with a blank message title. The body of the message should say: subscribe champ your name. Your subscription request will be forwarded for approval (1-7 days). Members in good standing (dues paid) will be approved. This now includes 1996 members; Council will decide shortly when member benefits (including CHAMP) end this year for non-renewers. HOW TO POST A MESSAGE ON CHAMP: e-mail to: champ@www2.pathology.pitt.edu. A descriptive title is encouraged to help members decide whether to read the e-mail. GENERAL INFORMATION ABOUT CHAMP: There are currently ~350 eligible e-mail addresses, making ~75% of AMP membership potentially reachable this way. CHAMP is 'moderated'; approval is required for listing, and messages are not accepted from non-member addresses, thus no annoying commercial stuff as on some other lists.

Contributed by Jeff Kant, MD, PhD. (kant@np.awing.upmc.edu)

CALL FOR NOMINATIONS

The Nominating Committee is accepting nominations for the following Council level positions: President-elect, Secretary-Treasurer, Training and Education Chair, and Program Chair-elect.

Pending changes in the by-laws, a call for nominations for committee representatives from each Subdivision will be made in June, so start thinking about this. BUT YOU DON'T HAVE TO WAIT. Send your nominations with candidate's name and contact information, nominated office (Council Level OR Committee Representative), and relevant qualifications. DONT BE SHY ABOUT NOMINATING YOURSELF. Send this to the AMP office or to Cheryl Willman by JUNE 16 (See membership directory for contact information).

REPORT ON THE USE OF HUMAN TISSUE CONTROVERSY

Both the Executive and Legislative branches of the Federal Government are considering the ethics of the use of human tissue in research studies and clinical practice. By Executive Order of President Clinton, the National Bioethics Advisory Commission (NBAC) was formed late in 1996, and has been deliberating on the rights of human subjects and on the use of human tissue for research, and the need for informed consent. The AMP has been following the deliberations of the NBAC very closely and we have had an opportunity to provide information to the Commission for their deliberations.

In addition, legislation has been introduced in the Congress that would impact on the use of human tissue in research and clinical practice. In March, a bill (S.422) was introduced in the Senate by Senator Domenici (R-NM), cosponsored by Senator Jeffords (R-VT), chair of the Senate Labor and Human Resources Committee, to which the bill has been referred. The Genetic Confidentiality and Nondiscrimination Act would require written informed consent for any research use of genetic information. The CAP Molecular Pathology Resource Committee as well as the CAP Committee on Human Tissue are preparing written critiques of S.422. The AMP is well represented on both committees.

Updates on the progress of NBAC and legislative initiatives, with a discussion of their potential impact on the practice of molecular pathology will be highlighted at the Annual Meeting in November.

Contributed by: Mark Sobel, MD, PhD, Secretary-Treasurer and Chair, Publications Committee, Laboratory of Pathology National Cancer Institute. (molpath@helix.nih.gov).

REPORT FROM THE SECRETARY-TREASURER ON GOVERNANCE

We are now in the middle of our second year as an official organization, operating under the Bylaws that were approved by the membership in 1995. During this year, we have had many successes, including the productive work of our committees through which the four scientific Subdivisions that are the underpinnings of the AMP interact. The Council has noted, however, that some oversights in the original Bylaws have led to a lack of continuity in committee membership. For example, in 1996, the membership elected an entirely new Clinical Practice Committee, and the Chairmanship of the committee changed hands as well. The Council has therefore recommended to the membership that an amendment to the Bylaws be passed that would change the terms of office of the representatives from each scientific Subdivision to the Nominating Committee, the Training and Education Committee, and the Clinical Practice Committee. Ballots were mailed to all regular members on April 18 and are due back in the AMP office, either by mail or fax, no later than June 6. If you have not yet received your ballot, please contact the AMP office immediately to get a replacement ballot. We depend on your input and hope that you will carefully consider the proposed amendment. If you have any questions, please feel free to contact me for any clarifications.

Mark Sobel

JOURNAL AFFILIATION COMMITTEE

AMP is exploring journal affiliation for the purposes of publishing the abstracts from our annual meeting, offering a journal subscription as a benefit of AMP membership, and providing a forum for publication of articles of interest to our members. We are currently reviewing responses from six different journals regarding the services that could be provided to our members. Anyone wishing to express their preference is welcome to contact a member of the Committee.

AMP Journal Affiliation Committee: Peggy Gulley (chair), R Braziel, A Killeen, T Williams

Contributed by Peggy Gulley, MD.

CLINICAL PRACTICE COMMITTEE

Your AMP Clinical Practice (CP) committee (Rick Press, Adam Bagg, Rick Nolte, Syd Finkelstein, Rob Wilson, and Debra Leonard) has lately been devoting its efforts to the following major concerns:

1) Response to the "Proposed Recommendations of the ELSI Task Force on Genetic Testing" This federally-mandated (under ELSI) task force chaired by Neil Holtzman (Johns Hopkins) was charged with making "recommendations to ensure the development of safe and effective genetic tests, their delivery in laboratories of assured quality, and their appropriate use by health care providers and consumers." The preliminary task force recommendations, published in the Jan 30, 1997 federal register, were open for public comment prior to the final task force meeting in March. Through the CP committee, AMP both devised its own response to these initial task force recommendations and issued an official letter in support of the CAP response to the same document. In summary, the task force proposed creating a complex, cumbersome, as-yet-ill-defined bureaucracy to regulate a relatively small area of laboratory testing which, we believe, could easily be accommodated by existing CLIA-mandated regulatory mechanisms, and enhanced by expanded proficiency testing, consensus development, or other guidelines. Some major recommendations to which AMP specifically objected concerned:

A. The recommendation that protocols for the clinical validation of genetic tests must receive the approval of an IRB. B. The recommendation that federal reimbursement for certain genetic tests be tied to documentation that i) "the test has been clinically validated", and ii) the laboratory is "qualified to provide such tests".

C. The recommendation that the FDA require that "stringent scrutiny" tests (as defined by a new federal bureaucracy called the National Genetics Board) be regulated under the Medical Device Amendments.

D. The recommendation that CAP/ACMG publicly "publish a list of laboratories performing genetic tests satisfactorily".

E. The recommendation that would "limit the offering of certain predictive genetic tests to genetics health care professionals with demonstrated competence in dealing with genetics issues".

The full text of both the task force recommendations and our official reply letter is available to interested parties - contact Rick Press (pressr@ohsu.edu) for details. The task force met on March 17-18 to consider our comments and those of other pathology and genetics professional societies - an official (presumably final) document has been promised to be released "soon". The regulatory "teeth" of such a controversial document remains to be seen. Stay tuned for future details.

2) The generation of "practice guidelines" for our most "popular" tests. We have chosen a test from each subsection that will be the subject of a "practice guideline" document designed to summarize key issues (and recommendations) concerning the clinical and laboratory utility of these tests. The initial AMP-sponsored practice guidelines will address factor V R506Q (Leiden) genotyping (genetics, Rob Wilson), p53 genotyping (solid tumors, Syd Finkelstein), HIV viral load assays (ID, Rick Nolte), and IgH PCR (hematopathology, Adam Bagg). In order to make these guidelines a true consensus statement, it is imperative that each of our members have appropriate input into these documents. I therefore strongly urge anyone with particular expertise, interest, and/or energy in any of these particular topics to contact either the subsection clinical practice committee representative or me, who will be spear-heading each guideline topic. In addition, we would greatly appreciate the opinions of those outside AMP who might be considered "experts" in these fields. Your assistance in identifying those "experts" willing to provide intellectual input into these practice guidelines would be much appreciated. Only with your help will these guidelines be a true consensus. Alternatively, do you really want these guidelines to reflect only the limited (and probably somewhat biased) opinions of just my esteemed committee colleagues and me?

3) Proposed new CPT codes For reasons not yet explained to me, the AMA CPT panel has recently turned down the request for new molecular CPT codes (including codes for such procedures as blotting, mutation identification, non-isotopic detection, etc.). the AMA Committee in charge of approving new CPT code swill reconsider the issue in Spring '98. The clinical practice committee is now fact-finding regarding this issue, and will soon attempt to come up with an appropriate response and action strategy.

As always, I welcome your ideas and contributions toward these and other pressing issues that face all of us in these rapidly-evolving times. I look forward to hearing from you.

Contributed by: Rick Press MD, PhD, Chair, Clinical Practice Committee and Director of Molecular Pathology, Oregon Health Sciences University. (pressr@ohsu.edu>)

TRAINING AND EDUCATION COMMITTEE

The Committee is in the midst of analyzing data from its recent survey of molecular pathology education in residency programs. We have received about 80 responses to date. Many AMP members completed survey forms for their institutions and we appreciate their efforts. A clear desire of the respondents is more guidance from AMP concerning necessary elements of basic molecular pathology education in pathology residency programs. The Committee is preparing guidelines to address this issue for discussion with AMP members and publication in a general interest pathology journal.

Below, we present a compilation of existing and proposed certification routes in molecular pathology for technologists and individuals with master's and doctoral degrees. Of interest are fellowships in molecular genetic pathology jointly proposed by the American Board of Pathology and the American Board of Medical Genetics. These fellowships would lead to certification for physicians who provide molecular diagnostic laboratory services. This potential means of certification will be discussed at the American Board of Medical Specialties meetings in the Fall. The Committee is preparing comments regarding the fellowships for the American Board of Pathology. Look for a posting of the details of the proposed molecular genetic pathology fellowships on CHAMP and the AMP home page:

http://www.pds.med.umich.edu/users/amp/

We would appreciate your comments, either posted on CHAMP or sent directly to our Committee through Tom_Williams@somasf.unm.eduCHAMP: champ@www2.pathology.pitt.edu

Certification Pathways in Molecular Pathology

AMP members may be interested in learning more about routes to certification in molecular pathology. Certification is relevant for technologists, master's level, and doctoral level AMP members. The Education and Training Committee has compiled the information below as a guide to various certification pathways. Portions of this information have appeared in past AMP newsletters; however, we felt a more comprehensive listing would be of use to members. Molecular pathology is a developing discipline and the certification routes which exist are often very new with few certified individuals. Some routes are still in the planning stages. Even so, we think that this information will be of use to you. Please note that we present this as a helpful, but unofficial, guide to certification. Contact the relevant boards for definitive information.

American Board of Bioanalysis The American Board of Bioanalysis (ABB) offers certification for directors, consultants, supervisors, and managers of clinical laboratories. ABB was established in 1968 in response to the 1966 Medicare regulations and the CLIA '67 Act, which defined the qualifications for laboratory directors. Over time, the ABB certification program was expanded: certification for supervisors, managers and consultants was included in 1972, 1982 and 1993, respectively. Medicare regulations for independent laboratories recognized ABB as a certifying agency in 1974, under Section 405.1312(b)(2) and (4). The regulations implementing CLIA '88 also recognize ABB as a certifying agency for laboratory directors and consultants. Many state laboratory programs also recognize the ABB director certification.

The current levels of ABB certification are: Bioanalyst Clinical Laboratory Director (BCLD), High-Complexity Clinical Laboratory Director(HCLD) and Moderate-Complexity Clinical Laboratory Director (MCLD). Two levels of consultant certification-Technical Consultant (TC) and Clinical Consultant (CC)-and two levels of supervisor, Technical Supervisor (TS) and General Supervisor (GS) are also available. Certification as Bioanalyst Laboratory Manager (BLM) is also offered.

PhD Laboratory Directors: The category most relevant for Molecular Pathology Laboratory Directors is HCLD. According to the ABB Certification Standards: To be eligible for certification as HCLD, an applicant must be qualified as a laboratory director of a laboratory performing high-complexity testing under CLIA '88 regulations, Subpart M, Section 493.1443, or fulfill the following requirements:

1. Hold an earned doctoral degree from an accredited institution with a chemical, physical, biological, or clinical laboratory science as the major subject and have successfully completed 32 semester hours (minimum) in chemistry or the biological sciences acceptable to the Board; AND

2. Have a minimum of four years of clinical laboratory training or experience, or both, including at least two years of experience directing or supervising high complexity testing; (For the specialty of Embryology, experience must include 60 personally performed, completed assisted reproductive procedures in humans.) AND

3. Pass an examination acceptable to the Board.

The ABB examination tests general laboratory knowledge and expertise in at least one of 14 specialized laboratory disciplines such as bacteriology, routine chemistry, and hematology. AMP members would likely want to sit for the general laboratory and at least the "Clinical Molecular Biology" specialized portion of this examination. The Board rules on eligibility for admission to the exam and provides content outlines [ED. NOTE: these outlines are not particularly useful-DHF]. Exams are offered twice annually. More detailed information and applications are available from the ABB. AMP member Dan Farkas, PhD, HCLD, CC, is an ABB diplomate and an additional source of information about this certification route. [ED. NOTE-I am willing to tell you about my experience but please direct your questions about logistics (dates, routes, reading list, etc.) of the exam to the ABB office; see contact information below-DHF]

Certification as Clinical Consultant (CC) may also be of interest for PhD AMP members. To be eligible for certification as a CC, an applicant must fulfill the following requirement: Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified as a High-complexity Clinical Laboratory Director by the American Board of Medical Microbiology, American Board of Clinical Chemistry, the American Board of Bioanalysis, the American Board of Medical Laboratory Immunology, the American Board of Pathology, the American Osteopathic Board of Pathology, or other board deemed comparable by HHS. AMP Members with Master's Degrees: Applicants with an MS degree in the chemical, physical, biological or clinical laboratory sciences may be ABB certified as Moderate-Complexity Clinical Laboratory Directors, Technical Consultants, Technical Supervisors, or General Supervisors. Applicants with an MBA qualify for Bioanalyst Laboratory Manager certification. The training and experience requirements and examinations given vary. Those interested may obtain the ABB Certification Standards brochure by contacting ABB.

To ensure that they meet eligibility requirements, applicants should contact the ABB to be certain that their training and experience has been in "an accredited institution" and/or "an acceptable clinical laboratory." Applicants holding degrees from educational institutions outside the US, must be evaluated by an ABB approved agency such as the International Education Research Foundation, Inc.

National Certification Agency: Medical Technologists Medical technologists may be certified as "Clinical Laboratory Specialists in Molecular Biology: CLSp (MB)" by the National Certification Agency (NCA) for Medical Laboratory Personnel. The first exam will be offered July 26, 1997 at several sites nationwide. [ED. NOTE-by the time this Newsletter goes out, it is not likely that NCA will accept late applications. Contact them or plan on taking the January 1998 exam-DHF]. Information about eligibility requirements, content outlines, exam locations, application packages and fees are available from NCA.

Briefly, the eligibility requirements for this new examination are: Route 1. Complete the equivalent of a minimum of one year experience in a full-service molecular biology laboratory.

Route 2. Successfully complete a post-baccalaureate certificate molecular biology education program sponsored by a college or university accredited by an agency approved by the US Department of Education, which includes the equivalent of six months experience in a full-service molecular biology laboratory. Definition: "A full-service molecular biology laboratory is defined as one capable of providing individuals with knowledge and practical experience in all aspects of molecular analysis including, but not limited to, recombinant DNA technologies, polymerase chain reaction, and hybridization techniques."

Biannual examinations are planned in January and July with application deadlines on October 1 and April 1, respectively. Beginning with the July 2000 examination, eligibility requirements will expand to 5 routes(defined in the current candidate handbook from NCA).

Proposed Fellowships: Mole. Genetic Pathology This joint pathway has been proposed by the American Board of Pathology(ABP) and the American Board of Medical Genetics (ABM) and is currently under consideration by the American Board of Medical Specialties(ABMS). It is not clear whether this route will be accepted by the ABMS or, if accepted, how the proposed guidelines will be modified. The ABP and ABMG proposal includes several important features: 1. One year fellowships are established leading to eligibility for an examination for certification in molecular genetic pathology.

2. This pathway will be available to physicians from pathology residencies or medical genetics fellowships. Because the responsible organization is the ABMS, certification will not be available to those with a PhD degree.

3. Approved fellowships will require experiences in broad areas of molecular pathology including infectious disease, hematopathology, histocompatibility, solid tumor genetics, and human genetics.

4. Experiences in anatomic pathology will be required for those with medical genetics backgrounds and experiences in clinical genetics for those with pathology residency backgrounds. A log book of cases will be required.

5. Examinations will be developed at a future date by a joint ABP/ABMG committee.

American Board of Medical Genetics The American Board of Medical Genetics, Inc. (ABMG) certifies individuals who provide service in medical genetics and provides accreditation of medical genetics training programs. The ABMG is an ABMS member. ABMG certification may be obtained in (1) Clinical Genetics, (2) PhD Medical Genetics, (3) Clinical Cytogenetics, (4)Clinical Biochemical Genetics, and (5) Clinical Molecular Genetics. Certification requires an appropriate training program and success on a general examination and relevant specialty examination(s).

The certification examination for Clinical Molecular Genetics is probably most relevant to AMP PhD and physician members. The examination is available to an individual holding a doctoral degree who is competent to perform and interpret molecular analyses relevant to the diagnosis and management of human genetic diseases, and who acts as a consultant regarding laboratory diagnosis of a broad range of disorders.

Applicants seeking certification as clinical molecular geneticists must submit verification of satisfactory completion of at least 2 years in an ABMG-accredited molecular genetics training program. At least half the training period should be spent in benchwork in molecular genetics and molecular diagnostics and involve the handling of clinical material for a broad range of cases with a broad range of techniques. A logbook of 150 clinical molecular cases must be submitted. No more than 25% of the cases may be in any one disease category.

The Board rules on eligibility. Requirements are subject to change for the next examination cycle (1999) with revisions expected to be available summer, 1997. Certificates are time limited for 10 years. Definitive information is available from ABMG.

Master's level trained genetic counselors are certified through the American Board of Genetic Counseling (ABGC). Specific information is available through the ABGC/ABMG.

Note: A possible avenue of certification for PhDs in the future may be through the American Board of Clinical Chemistry (ABCC), which has offered certification examinations for clinical chemists for many years. More information about possible subspecialty certification for Molecular Pathology laboratory directors may become available after the July 1997, annual meeting of the American Association of Clinical Chemistry, during which time an ABCC task force is scheduled to issue its report on this subject. Contact Herbert Milks, PhD(herbert.malkus@yale.edu) for more information.

CONTACT INFORMATION American Board of Bioanalysis 917 Locust Street, Suite #1100, St. Louis, MO 63101-1413' (314) 241-1445/7 (314) 241-1449

The American Board of Medical Genetics, Inc. ABMG Administrative Office 9650 Rockville Pike Bethesda, MD 20814-3998' (301) 571-1825/7 (301) 571-1895e-mail: "Sharon Robinson" srobinson@faseb.org

American Board of Pathology 5401 West Kennedy Boulevard, PO Box 25915, Tampa, FL 33622' (813) 879-4864

International Education Research Foundation, Inc., PO Box 66940 Los Angeles, CA 90066

National Certification Agency PO Box 15945-289, Lenexa, KS 66285' (913) 438-5110/7 (913) 541-0156

Compiled & contributed by Training and Education Committee members: Thomas M. Williams, MD, Chair. INFECTIOUS DISEASES SUBSECTION

The 1997 annual meeting is shaping up to be one of best ever. But then again, most of you probably don't need much of an excuse to go to San Diego in November! Roberta Madej and I took into consideration the many suggestions offered by the membership at last year's meeting when putting together this year's program. We hope you find the program both informative and stimulating.

Our first workshop, on Thursday afternoon, titled "Infectious Disease Proficiency Testing-Progress and Lessons Learned" will review the experience with several different proficiency testing programs. David Persing (Mayo Clinic) will discuss CAPÕs Molecular Infectious Disease program. Danny Wiedbrauk (William Beaumont Hospital, Royal Oak, MI)will share the results of a survey he and Rick Hodinka organized for the detection of HSV DNA in CSF. I will discuss the results of two recent European efforts, the Eurohep HCV, and the Netherlands Public Health Laboratory Mycobacterium tuberculosis surveys. The program will be moderated by Roberta Madej, the Infectious Diseases Subsection Chair-elect.

Our second workshop, on Friday afternoon, titled "HIV-Beyond Viral Load Testing" will focus on molecular tests to define specific antiviral resistance mutations, that may serve as prognostic indicators of disease progression, and that could be used as potential tests of cure. Scott Eastman, Chiron Corp., Debra Leonard, University of Pennsylvania, and Angela Caliendo, Massachusetts General Hospital, will serve as faculty for the workshop. I will moderate the session. Audience participation at both workshops will be encouraged, if not required.

Finally, our plenary session, on Saturday morning, will feature David Relman of Stanford who will speak on molecular methods for "new" pathogen discovery, and Jim Musser of Baylor who will speak on nucleic acid sequencing studies of pathogens. We are fortunate to have two such knowledgeable speakers for our program and trust that these topics will appeal to the entire AMP membership.

Rick Nolte, PhD, Chair, Infectious Diseases Subsection, Department of Pathol. & Laboratory Medicine Emory University School of Medicine. (fnolte@emory.edu).

SOLID TUMOR SUBSECTION

The Solid Tumor section will open the November meeting with a plenary session on DNA methylation. The primary speaker is Peter Jones, Director of the USC Cancer Center. He will review the theoretical and technical advances in this field, commenting on topics including new detection techniques, the relation of methylation to silencing of tumor suppressor genes, a causal role for methylation in mutation, and the relation of altered methylation to gross chromosomal instability. His title is "DNA methylation changes and cancer". He will be followed by 3 short presentations: 1. Gerd Pfeifer (Dept. Biology-City of Hope): "Effects of DNA methylation on formation of DNA adducts". 2. Joseph Costello (Ludwig Institute for Cancer Research-Web Cavenee's group): "2-dimensional genome scanning: human gliomas". 3. Jean-Pierre Issa (B Vogelstein's lab) is interested in the role of methylation in mismatch repair and chromosome stability: "Mismatch repair deficiency: a clue to hypermethylation in cancer?"

A workshop, "New and Emerging Tests", will be led by David Tarin, the new director of the USD cancer center, with short presentations by 3 AMP members. I would like to fill the second workshop with selected platform presentations from the submitted abstracts. Please consider this a call for abstracts: early submission is urged. If there is a major focus of interest we might be able to build a session around it.

THE OTHER TOPIC WHICH IS IN NEED OF PUBLICITY IS A CALL FOR AREAS OF INTEREST WITHIN THE SOLID TUMOR GROUP TO FORM THE CENTERS FOR LUNCHEON GROUPS AT THE MEETING, POSSIBLY BASED ON SPECIFIC TUMOR TYPES. I WOULD LIKE TO IDENTIFY (VOLUNTEER) SUBSECTION ORGANIZERS.

Contributed by: Sandra Wolman, MD, Uniformed Services University, Bethesda, MD. .

GENETICS SUBSECTION

The Genetics Session of the upcoming AMP meeting promises to again be a great success. With the explosion of discovery in many areas of human genetics, it was challenging to identify the topics that are most exciting and relevant to the practicing molecular geneticists, but I believe that we will be successful. As with the other sessions, there will be 2 plenary presentations at the San Diego meeting. In both, renowned and distinguished speakers have accepted the invitation and have very provocative subjects about which to speak. Maximilian Muenke is a professor in Pediatrics and Genetics at the University of Pennsylvania, based at the Children's Hospital of Philadelphia. His internationally acclaimed experience in the genetics of developmental and skeletal disorders will be highlighted in his talk: "The Molecular Genetics of Craniosynostosis". Dr. Muenke's expertise in skeletal deformation syndromes, and in the genetics of normal and abnormal brain development are revered. The discovery in recent years of a variety of point mutations in the fibroblast growth factor receptor have led to the characterization of a number of clinical genetic syndromes that involve malformation of the skeleton, face and brain. Dr. Muenke has authored several papers in this area, among them Nature Genetics 14:174-76, 1996 and Trends in Genetics 11:308-313,1995. His presentation in scheduled for 1:00 pm Thursday. The second genetics plenary speaker is well known to most AMP members. Dr. Richard Press, Assistant Professor and Associate Director of the Molecular Diagnostics Laboratory at the Oregon Health Science University will speak on Clinical and Molecular Aspects of Hemochromatosis. The identification of the C282Y mutation in the hemochromatosis gene on Chromosome 6 is very important to clinical practice. First, because the frequency of the mutant allele is very high, and secondly, because recent evidence indicates that even those heterozygous for the mutation are at increased risk for cardiovascular and hepatic disease, whereas the clinical syndrome hemochromatosis, is a classical recessive disorder. Consequently, there are a number of significant clinical issues that may be addressed by direct genetic testing. Dr. Press will speak to many of these emerging clinical issues in addition to highlighting aspects of the laboratory testing. His presentation is scheduled for 2 pm Thursday. Two exciting workshops are being developed for the Genetics Session. In a slight departure from the past 2 meetings where workshops were directed to the refreshment of skills for the practicing geneticist, the organizers of the 1997 Genetics Session are hoping to focus on aspects of laboratory techniques with one workshop entitled "A Practicum in Sequence Based Genetic Testing". This workshop will bring together the experience of 3 practitioners from 3 laboratories to discuss aspects of molecular diagnostics testing for three different diseases by direct sequence analysis. The discussions will focus on providing this type of service on a routine, cost effective and clinically informative basis, with special attention to aspects of specimen collection, PCR and sequencing chemistry and formats for reporting the data. The second workshop will also emphasize the role that molecular genetic testing plays in the multidisciplinary approach to Risk Assessment for Cardiovascular Disease. Now, a great number of gene markers are being evaluated for their significance in prognosing risk of cardiovascular events such as myocardial failure, infarction, hypertension, stroke and thrombosis. This workshop will address concerns associated with meeting the needs of clinicians who are eager to utilize new molecular markers in the assessment of their patients, while simultaneously maintaining a level of control in the laboratory by offering only those tests with proven clinical utility. This session will include the insights of clinicians and laboratories from several areas, but particularly molecular diagnostics to explore a multidisciplinary approach to assessing cardiovascular risk.

Ronald C. McGlennen, MD, University of Minnesota Hospital and Clinic. (mcgle001@tc.umn.edu)

MOLECULAR PATHOLOGY in SOUTH AFRICA

Molecular Pathology in South Africa is a relatively new discipline, with only a handful of Pathology departments offering adequate routine services. The rather limited number of molecular pathology services offered should be seen in the broader context of the country's financial constraints. With South Africa only recently emerging from more than forty years of oppressive, apartheid rule, the country's resources now(rightfully) have to be distributed more equitably. The present government has translated this vision into more money being provided for primary health care services, and less for tertiary hospitals and services.

The laboratory I am based at (University of Cape Town) came into existence approximately 3 years ago. In context of difficulties alluded earlier, we have to be creative to "survive" in a rather "hostile" financial jungle. The strategy we use is fairly simple i.e., we direct part of our research endeavors to investigate problems surrounding a particular diagnostic assay. In this manner for example, we performed a comprehensive study on various kinds of B-cell lymphomas in order to determine appropriate primer selection strategies for the detection of monoclonality in different B-cell lymphoma subtypes. Two years hence, the following has been achieved from this study:

i) the lab now offers routine diagnostic service for B-cell monoclonality detection by PCR

ii) a research paper summarizing our results has been accepted for publication

iii) the study formed part of a student's BSc (Hons) degree

iv) 2 thermal cyclers have been purchased from research money and are used diagnostically.

It should also be realized that tertiary hospital cutbacks have led to the loss of qualified laboratory staff. In other words, we have to perform the same amount of work with less personnel [ED. NOTE: an international phenomenon-DHF]. This in particular has limited our progress, especially in terms of the number (and types) of tests we are able to perform.

Bearing such difficulties in mind, our laboratory have managed to set-up 3 molecular diagnostic assays during the last few years: PCR detection of B/T-cell monoclonality and detection of the t(14;18)translocation (in follicular lymphomas).

What about cost recovery? In order to become less dependent upon the state, we have embarked on a marketing strategy, where established assays are being offered to the private sector. In this manner we hope to be able to generate enough income to cover the cost of the laboratory's consumables.

Contributed by: Faadiel Essop, PhD, Molecular Pathology Section, University of Cape Town Medical School. .

FROM THE EDITORThis is a reminder to vote on the bylaws change recently distributed byAMP through Secretary-Treasurer, Mark Sobel. The bylaws change voteinvolves adjusting the length of certain terms of office to providegreater continuity in the operation of AMP Standing Committees. If youdid not receive this ballot, please contact the AMP office:Phone, (301) 571-1880 FAX, (301) 571-1879 e-mail: AMP@pathol.faseb.org

USE CHAMP & THE AMP LISTSERV & VISIT THE HOME PAGEchamp@www2.pathology.pitt.edumxdiag-l@health.state.ny.us (before the @ is the letter "l", not thenumber "1")AMP Home Page: http://www.pds.med.umich.edu/users/amp/