AMP ANNUAL MEETING November 14-17, 1996 Omni Inner Harbor Hotel 101 West Fayette Street Baltimore, MD 21201 (410) 752-1100/FAX (410) 752-0832 PRESIDENT'S MESSAGE Messages from the President are tough to write. If you're doing your job (other than keeping things generally on track and strong-arming people to become members), a significant activity is summarizing and promoting the work, efforts and ideas of others within the organization. For a newsletter, you can't hit specifics too hard and steal the thunder of these others, yet you have to say something. Those specifics on much of what AMP is up to you'll hear from Committee chairs and others elsewhere in these pages. The significant growth in AMP and its activities this year has been a real endorsement of what we're about (even allowing for a minor amount of strong-arming!). Membership is nearing 400; we have a modest group of international members and a request from Central America to help support a regional group with similar interests, and there has been an excellent response from the membership in standing for elected office. With more focus and time for planning (along with a lot of hard work), the annual meeting looks better than ever, and attracting exhibitors has been extremely successful. The meeting has the flavor of a large Gordon conference with a clear primary focus on clinical applications of molecular biology; virtually all attendees share that interest which facilitates talking within sessions as well as to individuals. The larger 'cattle-drive' meetings like ASH, ASHG, ASM, ASCO, etc. serve a different purpose. We've also begun to explore possible journal sponsorship to further promote molecular pathology and AMP. Perhaps most significantly, we've had the real opportunity to participate in and influence decision-making on issues that affect our everyday practice on clinical, regulatory, and ethical fronts. I hope the continuing increase in numbers and interest in molecular pathology can be translated into an active interchange of problems, thoughts and ideas among the general membership between meetings to maintain the energy which develops each mid-November. To facilitate this, AMP launched the CHAMP bulletin board last May. It is functioning reasonably smoothly, and I am working with our informatics group at Pitt to iron out bugs; if you've paid your dues and have an e-mail address but are not receiving these postings, let me know. CHAMP has been particularly useful to quickly inform members about issues, as well as to provide reminders and field an occasional query - my thanks to all who have posted items and to those who have provided feedback to me. It is my hope over the next year that we can develop a more active exchange of relevant chatter within and among individual subsections. I know everyone faces multiple other responsibilities, but feel free to put your toe in the water any time. If anyone has any ideas for the Internet equivalent of a pitcher of beer and a basket of wings to grease the skids, let me know - a pitcher of margaritas would be even better! I've really enjoyed my activities with AMP this year, and I appreciate the opportunity and the honor to serve as your President. I look forward to the next 4 months and another year on Council helping promote what has been a good beginning. And also to seeing you all in Baltimore (Bal-mer in the local lexicon) this November. Contributed by Jeffrey A. Kant MD, PhD Division of Molecular Diagnostics Department of Pathology 7 Scaife, 3550 Terrace Street Pittsburgh, PA 15261 ( (412) 648-8519/FAX (412) 383-9594 kant@np.awing.up0mc.edu. MESSAGE FROM THE EDITOR (I moved my comments to pg. 2. I got my kicks on pg. 1 of the last newsletter. Now I guess it’s time to give the Pres. top billing.) AMP Annual Meeting TIME IS SET ASIDE (7-11PM) ON NOVEMBER 14 FOR AMP COMMITTEE MEETINGS AT THE ANNUAL MEETING. COMMITTEE CHAIRPERSONS SHOULD CONSIDER HAVING THE STANDING COMMITTEE MEMBERS AS WELL AS THE MEMBERS ELECTED TO SERVE IN 1997 MEET JOINTLY DURING THIS TIME TO PROVIDE CONTINUITY FOR THE WORK OF THE COMMITTEE. Molecular Diagnostics Laboratory Personnel Certification At the American Association for Clinical Chemistry meeting in Chicago this past July, a meeting of the directors of the American Board of Clinical Chemistry (ABCC) occurred. At the meeting, ABCC stopped arguing about whether it should offer a subspecialty certification examination for molecular pathology laboratory directors and began the discussion of how such an exam should be implemented and what the content should be. An ad hoc subcommittee was appointed to explore different possibilities. It is possible that an ABCC sponsored examination will be available in 1997. The American Board of Bioanalysis (ABB) is located at 917 Locust Street, Suite 1100, St. Louis, MO 63101-1413; ( (314) 241-1445; FAX (314) 241-1449. ABB administers certification examinations in several disciplines and recently “Clinical Molecular Biology” was added to this list. Requirements to apply for sitting for the examination include holding “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 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.” Application, which requires undergraduate and graduate transcripts and fees, may be made to a board which rules on eligibility to sit for the exam. The exam includes some questions on administrative knowledge. A content outline is available. Those who pass the exam are certified as High-complexity Clinical Laboratory Directors (HCLD). An exam was offered in November in Boston and will next be offered in May 1997, in Houston. Contact ABB for an application and further information. The National Certification Agency is involved in these certification issues too. See Cathie Leiendecker-Foster’s note on this below. CPT Codes Earlier this year, Drs. Wayne Grody and Michael Watson made a presentation to the American Medical Association Current Procedural Terminology (CPT) Panel in support of an expanded list of molecular CPT codes that seemed to go well and be well received (see Molecular Diagnosis, 1996, 1(1): 75-77. Unexpectedly, the panel suspended its consideration of expanding the number of molecular CPT codes; the earliest these additional codes may go into effect is now January 1998. Contributed by Dan Farkas, PhD Editor, AMP Newsletter Molecular Probe Laboratory William Beaumont Hospital Royal Oak, Michigan (810) 551-5077 FAX (810) 551-3694 dfarkas@beaumont.edu 1996 AMP MEETING We are fortunate to have a very impressive list of speakers this year to deliver plenary session and workshop talks at the 1996 Annual Meeting. The full list of speakers and titles has been mailed to all members and is available on the AMP home page, http://www.pds.med.umich.edu/users/amp. There will be plenary sessions and workshops in Genetics, Hematopathology, Infectious Diseases, and Solid Tumors. Sixty-six abstracts have been accepted for presentation at the Meeting. These cover the wide range of interests of AMP members. Twenty-four abstracts will be presented as platform presentations. In addition to the academic activities, the Annual Meeting is a wonderful opportunity to socialize with colleagues from other institutions, network, and make new friends. Please join us in Baltimore, MD, November 15-17. Remember, time is set aside on the evening of November 14 for committee meetings. Contributed by: Anthony A. Killeen, MD, PhD 1996 Program Chair Director, Clin. Chem./Molecular Diagnostics University of Michigan, Ann Arbor ( (313) 936-1873/FAX (313) 936-2756 akilleen@umich.edu NOMINATING COMMITTEE REPORT: ELECTION OF OFFICERS The Nominating Committee developed an outstanding slate of nominees for elected office in AMP. Ballots were distributed in September to all regular members of AMP, and election results will be announced over the CHAMP listserv and at the upcoming annual meeting. Thank you to all of the members of the Nominating Committee for your work in developing an excellent slate of candidates. For those members who have not previously held a leadership position in AMP, there will be plenty of opportunities in the coming year, and we encourage you to join your colleagues in participating actively in the organization. JOURNAL AFFILIATION COMMITTEE REPORT AMP is considering affiliating with a journal for the purposes of (1) publishing our meeting abstracts and announcements, (2) possibly offering a journal subscription as a benefit of membership in AMP, and (3) providing a forum for publication of articles of interest to our members. To aid in our evaluation of possible journals for affiliation, an ad hoc Committee of the AMP Council was appointed; members of this committee have no potential conflict of interest, i.e., they do not hold major office in another society or sit on the editorial boards of potential journals. The Committee developed a list of specifications, and requested proposals from several publications each of which responded favorably to our inquiry. The choice of a journal for AMP affiliation involves a number of considerations. These include relatively easily quantifiable data such as the number of subscribers and the costs to AMP of abstract publication and subscriptions. Other important issues are more difficult to evaluate precisely. The relative quality of well established journals and the degree of promise of recently launched publications are difficult but important judgments. The comparative value of affiliating with a general pathology journal versus one focusing on molecular pathology is a critical issue. The Journal Affiliation Committee developed a poll on this topic that was distributed in Sept. to all regular AMP members. This poll assesses whether to proceed with affiliation, whether a journal subscription is expected as a membership benefit, and which journals should be considered and are preferred. Results of this poll will be reported at the annual meeting at which time the Journal Affiliation Committee will make a recommendation. In the interim period until a final decision is made on journal affiliation, the Committee selected the American Journal of Pathology to publish 1996 AMP annual meeting abstracts. Only those abstracts designated as “original submissions” will appear in the journal’s November issue. Abstracts submitted for the annual meeting that are not original will still be included in the meeting proceedings. If you have comments regarding journal affiliation, please contact a member of the AMP Journal Affiliation Committee, or share your thoughts publicly via the CHAMP listserv. Committee members are: · Peggy Gulley, Chair, University Texas San Antonio · Rita Braziel, Oregon Health Sciences University · Tony Killeen, University Michigan · Tom Williams, University New Mexico Contributed by Peggy Gulley, MD AMP President-elect Department of Pathology University of Texas Health Sciences Center San Antonio, TX 78284-7750 gulleym@uthscsa.edu CLINICAL PRACTICE COMMITTEE The Clinical Practice (CP) Committee formulated the response of the Association for Molecular Pathology to the FDA proposal for regulation of analyte specific reagents, and submitted it before the June 12 deadline. AMP expressed the opinion that the regulations currently in place through HCFA under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88), and the College of American Pathologists are sufficient to insure high standards for in-house developed assays. Therefore, the AMP opposed the formalization of the proposed FDA regulation. Twenty-nine responses were received by the FDA. A new draft of the regulations has been written, which includes the comments submitted to the FDA and the FDA response to those comments. This new draft is currently being reviewed by the FDA, and will be available soon. The CP Committee will receive a copy of the new draft of the proposal at that time, and will forward the information to the AMP membership either through sessions at the November meeting or through CHAMP. A copy of the proposal will also be available on the FDA homepage. Work continues on collecting and compiling test information for a directory of tests performed by laboratories of AMP members. Many laboratories have submitted test information already. The deadline for submission was moved to late September. A hard copy and a disk containing the test information for your lab should be sent to the AMP office if you have not done so already. The directory will be available to AMP members at the AMP meeting in Baltimore. Those members unable to attend the meeting will receive a copy of the directory by mail after the meeting. Dr. Michael Whittaker has completed a first draft of the guidelines for the in-house development of molecular pathology assays, and has received comments from the rest of the CP Committee members. The Committee plans to have the guidelines finalized by the AMP meeting in November. Contributed by Debra GB. Leonard, MD, PhD Chair, Clinical Practice Committee Department of Pathology/Lab Medicine Hospital-University of Pennsylvania debra_leonard@path1a.med.upenn.edu PUBLICATIONS COMMITTEE Dr. Tom Frank, Dr. Cheryl Willman, and Dr. Sandra Wolman were named to the Publications Committee. Dr. Dan Farkas, AMP Newsletter editor, is an ad hoc member. These members bring to the committee their broad experience in various aspects of molecular pathology and have research interests including hematopathology, solid tumors, infectious disease, and genetics. Dr. Frank has been responsible for the AMP Home Page on the World Wide Web. Dr. Willman is one of the founders of AMP, and sits on several editorial boards. Dr. Wolman, in addition to having experience on the editorial boards of several journals, has been a member of the Publications Committee of the ASIP, and is now Chair of that committee. Her expertise will be extremely useful as the AMP Publications Committee begins to implement the decisions of our society concerning future journal affiliations. UPDATED AMP MEMBERSHIP DIRECTORY The AMP membership directory is a useful tool for AMP members to stay in contact. Please report any address corrections by e-mail to AMP@pathol.faseb.org Karen Kaul, MD, PhD is chief of molecular diagnostics at Evanston Hospital and is an active AMP member on the Clinical Practice committee. She may now be reached through e-mail: k-kaul@nwu.edu David Cooper, PhD, MD is Past-President of AMP. His correct e-mail address is: cooped@a1.isd.upmc.edu Thomas Frank, MD, an active AMP member has moved from the University of Michigan; he is now the medical director of Myriad Genetics in Salt Lake City. He may be reached at tfrank@myriad.com UPDATE ON PATHOLOGY'S RESPONSE TO THE ELSI WORKING GROUP In January, 1996, an ad hoc committee was organized by the College of American Pathologists to draft a consensus statement to represent the views of pathologists on the use of stored tissue in research. In the last newsletter, we reported that the ad hoc committee met during the USCAP meeting in March with representatives of interested pathology and science organizations. Based on the extensive discussions at the March meeting, the ad hoc committee sent a revised draft statement to interested societies in May 1996. AMP members Wayne Grody, Victor Weedn and Mark Sobel participated in the drafting of the statement. The majority of the societies approved the draft in concept, and made several editorial suggestions which were put into effect during the summer of 1996. The Board of Governors of the CAP approved the statement in August. The AMP is a cosigner of the statement. This statement is available to all AMP members, and copies will be provided at the Annual Meeting in November. The ELSI (Ethical, Legal, and Social Implications) Working Group has named a subcommittee to draft an official position on the use of stored human tissue. The CAP ad hoc committee provided a draft of the pathology statement to the ELSI subcommittee so that its members can consider pathology's position. This issue will be addressed in depth at the Annual Meeting in November on Saturday morning, when Dr. Elizabeth Thomson of the ELSI branch at the National Center for Human Genome Research and Dr. Mark Sobel of the AMP will present their positions. During the summer, there were several legislative actions at the federal level that may have an impact on the use of stored tissue. A major impetus for concern about the misuse of genetic information has been the danger of losing health care coverage for so-called "pre-existing" illnesses, including inheritance of susceptibility genes. Some good news was the passage and signing of a bill that will protect health care coverage for individuals who change jobs and who have a genetic susceptibility. However, this bill does not cover individuals who are not already carrying health insurance. In 1995 and 1996, several Congressional legislators introduced legislation relating to genetic privacy. Many in the pathology and genetic communities have expressed concern about the language used in the proposed Acts, since broadly worded concepts may be interpreted to prevent the use of specimens that were obtained during the course of usual medical practice in diagnostic assays as well as in research studies. The most recent proposed legislation was introduced by Senator Pete Domenici (R-NM). "The Genetic Confidentiality and Nondiscrimination Act of 1996", S.1898, would make it illegal for third parties to collect, store, analyze or disclose an individual's genetic information. Third parties would have to obtain specific informed and written consent, and substantial financial penalties would be imposed for noncompliance. It is unlikely that this proposed bill or any other will make any significant headway during the current Congressional session. New bills will have to be introduced after the new Congress is convened in January 1997. The CAP and other interested societies and organizations are in the process of contacting legislative staffs to educate them about concerns with the use of some of the terminology in these bills. Contributed by: Mark E. Sobel, MD, PhD Chair, Publications Committee Laboratory of Pathology National Cancer Institute molpath@helix.nih.gov MORE ON CERTIFICATION As reported in the May newsletter, efforts are underway to provide a certification examination for molecular testing personnel by the National Certification Agency (NCA) for Medical Laboratory Personnel. The exam is expected to be offered in or around July 1997. Dr. Dan Farkas and I are members of this examination development committee. I will also be participating in a task force that will make recommendations to the NCA Board of Directors regarding the exact credential assigned and eligibility routes allowed. Although the examination will be designed for entry level molecular technologists, anyone meeting the eligibility requirements will be allowed to sit for the exam. In late August, a "job analysis" survey was mailed to personnel randomly selected from the molecular diagnostic testing community. Responses to this survey will be used to help establish the areas of practice to be tested. Anyone who has received one of these surveys is encouraged to complete and return it promptly. The more input there is, the better the exam! I will keep you informed about the progress of this exam. NCA may be reached at PO Box 15945-289, Lenexa, KS 66285; ( (913) 438-5110; FAX, (913) 541-0156. Contributed by: Cathie Leiendecker Foster, MS Dept. Pathology/Lab Med.-University of Minn. School of Medicine, Minneapolis foste011@maroon.tc.umn.edu HEMATOPATHOLOGY SUBSECTION The upcoming annual meeting of AMP promises to be both entertaining and educational for those interested in hematopathology. The sessions will cover a wide variety of topics, ranging from formal lectures to informal panel discussions. The theme of the plenary session could be considered to be lesions associated with a herpes-group virus. Dr. Ethel Cesarman will detail her work in the identification and characterization of the Kaposi's-associated Herpesvirus, which is found in a unique subset of AIDS-related lymphoma. Dr. Joe Locker, who has a long-term interest in EBV-driven post-transplant lymphoproliferative disease, will relay his experience with this group of problematic disorders. A wide variety of abstracts have been received, and will be presented in both platform and poster formats. The authors of these studies and newly-developed assay protocols will be available for questions and discussion during both sessions. In a late afternoon session, Drs. Fred Behm and Jim Downing, both from St. Jude’s Hospital, will give that institution's experience with molecular markers of prognostic significance in acute lymphoblastic leukemia. In particular, Dr. Behm will discuss his work with changes involving the MLL gene at 11q23, and Dr. Downing will update the group on his experience with the PCR detection of the relatively common, but cryptic, fusion of the Tel and AML-1 genes. In the final hematopathology session, a panel of discussants will attempt to engage the group in a practical exchange of ideas related to the reporting and control of molecular studies. Some examples of the report formats used at other institutions will be presented. The use of controls for some of the more common tests, as well as sources of possible control material, will also be discussed. Audience participation will be encouraged. Additionally, information on the molecular CAP survey will be presented and newly elected officers will be announced. As in the past, the atmosphere will be cordial, and time will be available at all sessions for discussions and questions. In fact, if a particularly problematic or useful aspect of molecular diagnosis can be illustrated by a case presentation, meeting participants are invited to share this with the group. Previous case-oriented discussions have been well received, and anyone interested in doing a brief presentation should contact Dr. Traweek. Contributed by: Thomas Traweek, MD Chair, Hematopathology Subsection Department of Pathology Duke University Medical Center trawe001@mc.duke.edu SOLID TUMORS SUBSECTION The Solid Tumor group is looking forward to an informative and stimulating set of speakers and discussions at the annual meeting in November. One issue of particular concern is anticipated legislation regarding use of stored tissue samples for research. This is an issue which will likely be discussed at length at the meeting and is an area of obvious concern to the Solid Tumor group. Development and validation of prognostic genetic and chromosomal markers for solid tumors absolutely depends on tissue samples, either archived or acquired prospectively. Mark Sobel in this issue is providing an update on the current legislative status of genetic testing and use of stored tissue for research and I refer you to his discussion. It behooves every member of the Solid Tumor group to stay informed about this issue. Contributed by: Linda Wasserman, MD, PhD Chair, Solid Tumors Subsection Departments of Medicine & Pathology University of California-San Diego INTERNET ADDRESSES: CHAMP (CHat AMP) exists to promote communication among AMP members. See instructions below on how to participate. AMP home page is http://www.pds.med.umich.edu/users/amp/ The Solid Tumor section’s home page may be accessed through the AMP Home page. At present the Solid Tumor working group is the first to have a home page, and we are encouraging other groups to add theirs as well. News in Bioscience and Medicine: http://www.informatik.uni-rostock.de/HUM-MOLGEN/NewsGen/ Information on various aspects of human genetics: http://www.faseb.org/genetics/ HUM-MOLGEN WWW: http://www.informatik.uni-rostock.de/HUM-MOLGEN/ European Directory of DNA Laboratories (EDDNAL) http://www.eddnal.com The European Directory of DNA Laboratories (EDDNAL) is mainly intended for clinical geneticists and molecular biologists. It provides contact names and addresses for 280 DNA laboratories and details services on 385 genetic diseases. The Task Force on Genetic Testing of the National Institutes of Health-Department of Energy Joint Working Group on the Ethical, Legal and Social Implications of Human Genome Research (ELSI Working Group) has developed Interim Principles primarily regarding scientific validation of new tests; laboratory quality; and education, counseling, and delivery. At a 9/24 meeting, the Task Force continued its consideration of recommendations to implement the Interim Principles, as well as revisions to the Interim Principles. The Interim Principles are available on the World Wide Web at: http://infonet.welch.jhu.edu/policy/genetics/ AMP continues to promote 2 uses of the Internet: (i) dissemination of information regarding AMP activities and (ii) to promote communication among members. One electronic forum is a special Listserv (or e-mail list) exclusively for AMP members. This Listserv, called "CHAMP" (for "CHat AMP"), is an e-mail address that sends messages simultaneously to all members with valid e-mail addresses. All current AMP members with e-mail addresses on file have been automatically subscribed to this Listserv. Although individuals will be able to remove themselves from this Listserv it is certainly hoped that none will want to! If you are a new member, have recently obtained or changed an e-mail address, or if you were tardy in renewing your membership you can still subscribe to CHAMP. Send an unadorned (no embedded text such as "STMP," for example) e-mail with a blank subject line, containing only the message SUBSCRIBE CHAMP [your e-mail address] to the following administrative address: majordomo@path.upmc.edu If you are an active member, you will receive a confirmation of your subscription, usually within 1-2 days with instructions on how the listserv operates. CHAMP is unmoderated, but only AMP members will be allowed to subscribe. AMP LOGO Here are the 5 submissions for the AMP logo. Please direct any comments to Dr. Mark Sobel at (301) 496-7999 or molpath@helix.nih.gov. There will be time set aside at the Annual Meeting for discussion of the logo. Thanks to those who made these submissions.