By Karen P. Mann, MD, PhD
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 (ie 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.
The impending NIH molecular test registry is another issue that has the potential to greatly affect our membership. Many of our members who direct or work in clinical laboratories are concerned with the impact on our already short-staffed laboratories. Other members see it as an improvement in patient care. From my viewpoint, the important thing is that AMP is also actively engaged in the issue. We are working with the NIH to determine how our test directory will (or won't) fit into the scheme and will maintain our involvement in this area. Our members are engaged with NIH information technology staff to help facilitate possible sharing of data between the AMP Test Directory and the NIH registry.
I mention these two initiatives as they will affect us all to greater or lesser degrees. There are numerous other completed and ongoing initiatives that are equally important that I cannot highlight here. What I do want to discuss is AMP's future. Over the last few years, there has been a dedicated effort to increase AMP's visibility so as to become the "go to" organization when questions of molecular diagnostics arise. We seem to have substantially accomplished this (once again, just ask our volunteers and office staff). The next question is where are we going from here? If you read this Newsletter and come to the business meeting at the Annual Meeting in San Jose, you will see how busy our Committees are. We are adding new Committees and Subcommittees (e.g. Budget and Finance, Economic Affairs, Membership and Professional Relations) and are taxing our main office staff and our volunteers. There are additional initiatives, that have been proposed by the Strategic Planning Committee as well as by other AMP members that we currently do not have the necessary resources to accomplish. Historically our solution has been to recruit more volunteers and expand office staff as necessary. At this point, it is time to move to a more proactive process.
We are in the initial stages of a formal Strategic Planning process. Our goal is to develop a roadmap for the future that will help guide the organization in allocation of resources and allow us to accomplish the many things we wish to accomplish. This will give us a yardstick to judge initiatives as we move into 2011. Currently, we have sent out an RFP (Request for Proposal) to identify consultants to help facilitate the Strategic Planning Process. The AMP Council hopes to spend a considerable amount of time at the Annual Meeting discussing our long-term goals and objectives. This is a good time to start thinking about what you deem is important and to share with AMP leadership.
This is an exciting time for AMP and for Molecular Diagnostics. I am looking forward to what the future brings. See you in California.