By Karen P. Mann, MD, PhD
Emory University
e-mail: kmann@emory.edu
The year is flying by and I am looking forward to seeing all of you in San Jose. This will be our first meeting at a stand-alone convention center, a landmark in our continued growth. During my stint as President, I am continually impressed at how hard-working our committee members and people in the home office have been and I encourage you to read all the articles in this Newsletter, so you will be up-to-date on what they are doing. The old saw reads "if you want something done, ask a busy person." The truth of that expression is proven many times over by our committee members, main office staff, and volunteers.
Two national items that have kept many of us busy are: the FDA's move to exercise oversight of laboratory-developed tests (LDTs); and, the move of the NIH to develop a national registry of non-FDA cleared molecular tests (i.e., molecular LDTs). There are a spectrum of opinions about the necessity and benefit of each of these, but practically speaking, both are becoming a reality. As usual, "the devil is in the details." FDA has always claimed regulatory authority over LDTs, but until recently did not exercise this authority (i.e., FDA exercised regulatory discretion). AMP is highly engaged in working on this issue. I was an invited panelist at the recent FDA LDT workshop and Elaine Lyon (Chair of Professional Relations Committee) presented the AMP public comments at the same Workshop. AMP is trying to ensure that FDA is aware that laboratory developed tests are found in all areas of the laboratory, not just in molecular laboratories, and are integral to medical care. In addition, AMP is working to ensure that any additional oversight is judiciously and carefully implemented with thorough awareness of current regulatory oversight so as to avoid redundancy and over burdensome regulation. We are working with the College of American Pathologists (CAP), American Clinical Laboratory Association (ACLA), American Society for Clinical Pathology (ASCP) and other laboratory organizations so as to be heard as a single voice. This is an ongoing effort. >>Read the article
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2010 Recipient of
AMP Leadership
Award
The members of the
Nominating Committee and AMP Council are pleased to announce Andrea Ferreira-Gonzalez, PhD as the recipient of the 2010 AMP Leadership Award. Dr. Ferreira-Gonzalez is Professor and Chair of the Division of Molecular Diagnostics in the Department of Pathology at the Virginia Commonwealth University. She pursued her graduate education the National University of Cordoba, Argentina, and received her doctorate in Microbiology/Immunology from George Washington University, Washington, DC. She joined the faculty of Virginia Commonwealth University as an Assistant Professor in 1994 and achieved her rank in 2005. >>Read the article |
 2010 Recipient of the AMP Award for Excellence in Molecular Diagnostics
Patrick O. Brown, MD, PhD is this year's recipient of AMP's Award for Excellence in Molecular Diagnostics. He is being honored for his pioneering work in
studying patterns of gene expression in development and disease, as well as the development of DNA microarrays, a technical and philosophical advance that has transformed our understanding of cellular regulatory processes. >>Read the article
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