By Elaine Lyon, PhD Chair, Professional Relations Committee e-mail: lyone@aruplab.com

As we enter the New Year, we would like to thank last year’s Professional Relations Committee (PRC) Chair, Jean Amos Wilson, for her leadership.  Thankfully, Jean will remain on the Committee and help with my transition.  Our thanks also go to Debra Leonard, Angie Caliendo, Wayne Grody and Michele Schoonmaker who are rotating off the Committee.  We are very grateful for their time, effort and expertise, and know they remain strong supporters of AMP’s causes.  This left a few openings on the Committee.  AMP members responded to the call for volunteers and we welcomed new members at our last conference call.  Thanks to all who are willing to serve.  The qualifications of AMP members are truly impressive.    Members who continue to serve are Jean Amos Wilson, Roger Klein, Vicky Pratt, Jan Nowak, Tim O’Leary, Roberta Madej, Shelby Melton and Andrea Ferreira-Gonzalez. Welcome to the 2010 incoming PRC Committee members Steve Day, Dan Farkas, Dan Sabath, and Rajyasree Emmadi.

The Committee’s work continued throughout the Holidays with very little slow-down.  Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) requested comments regarding usefulness of pharmacogenetic tests for oncology, namely, Her2, bcr/abl, CYP2D6, K-Ras and UGT1A1.  We sent a message over CHAMP asking for members’ input.  Over a few days time, approximately 75 members responded to a survey.  The results will be the basis of AMP’s comments at MEDCAC’s meeting scheduled for January 27.  Thanks to Jan Nowak for developing the survey and presenting for AMP and to all of you who responded.  For those interested in the results, they will be posted on AMP’s website when they are presented to MEDCAC. 

A main focus of the PRC recently has been in developing a statement outlining the benefits of laboratory developed tests (LDTs).  They are a mainstay of clinical testing and their value should be recognized.  The statement will be taken to the FDA as talking points for our visit with them in January.  This document was written from the Committee’s animated discussion at the 2009 AMP Annual Meeting.  Thanks to Jennifer Leib from HealthFutures for organizing and writing this statement.  It will be posted on AMP’s website. 

PRC will also be responding to the FDA’s IVDMIA Final Guidance and to the SACGHS Gene Patent report.  We will emphasize points from our statements previously developed.  For the FDA IVDMIA guidance, AMP encourages following the rulemaking process and utilizing an external advisory committee to classify tests.  For the SACGHS report, we will re-iterate AMP’s position on gene patents and urge the SACGHS to retain the draft recommendations. 

Thus is my initiation as Chair of PRC.