Association for Molecular Pathology

Newsletter

October 2011, Volume 17, Number 3

 

AMP Pharmacogenetics Interest Group (PGX IG)

By: Barbara Zehnbauer (e-mail: bzehnbauer@cdc.gov) and
Steve Schichman (e-mail: schichmanstevena@uams.edu)

Welcome to the AMP Pharmacogenetics Interest Group! Members of this PGX IG have indicated an interest or involvement in PGX testing for diagnostic, clinical trials, or research applications. Through the AMP Newsletter and the AMP PGX listserve, we will bring attention to key issues related to PGX laboratory testing practices. The PGX IG leaders will help identify priorities and develop strategies to address areas of concern such as model reporting of PGX lab results; identification of PGX reference materials and proficiency testing; effective coordination with other medical professionals; and understanding requirements for regulatory compliance.

To better understand the views and needs of PGX IG members, we enlisted the expertise of AMP's Kathleen Carmody to develop and distribute a brief survey earlier this year to ascertain the types of PGX testing performed by AMP members. There were 93 responses, with more than 85% from individuals who were actively performing PGX testing. Other principal findings were:

  • >70% were performing clinical diagnostic PGX testing.
  • Nearly 25% were planning future PGX testing.
  • 80% of respondents supported addressing model PGX test reports by the PGX Interest Group.
  • An equal number of respondents (68%) indicated testing for somatic and inherited PGX signatures.
  • More than 35 different genes were listed as PGX testing targets; 16 were heritable variations involved in drug metabolism and 21 were mutated in tumors. The need for appropriate reference materials was indicated.
  • Several survey responses also reported microbial drug resistance as PGX testing.
  • Almost two-thirds of respondents participated in PGX proficiency testing or alternative quality assessment.
  • Most respondents used both commercial testing kits and laboratory developed tests for PGX testing.

These results will form the priorities for future projects of PGX Interest Group members. Model test reports and proficiency testing were top items of interest and value to members. Integration of PGX test findings into clinical decision-making will be essential to the understanding and effective use of these genetic signatures as complementary to other diagnostic testing and therapeutic drug monitoring. Some of the areas of concern identified by survey responses will also be included in a new CLSI guidance document in development focusing on Molecular Diagnostic Methods for Non-hematologic Cancers with the contributions of many AMP members. The PGX Interest Group leaders will keep AMP membership informed about the very active areas of regulatory, technological, and clinical PGX developments.

This has been a very active period of time for pharmacogenetics including increased recognition of gene targeted therapeutics, FDA approval of companion diagnostics, and research demonstrating the utilization of gene expression data to reposition existing drugs. The clinical laboratory's role in pharmacogenetic testing and personalized medicine delivery is assured despite the considerable regulatory, legislative, and reimbursement obstacles to be overcome.

If you would like to join the AMP PGX IG, the PGX listserve, or have other suggestions to contribute about PGX IG, please contact Steve, me or the AMP staff at amp@amp.org. We have also arranged a brief meeting of PGX IG members on Wednesday, November 16, 2011 at 5:00PM at the end of the Corporate Workshop Day at the AMP 2011 Annual Meeting. Hope to see you in Grapevine, TX!