Washington, DC – June 12, 2009 – In public comments given today before the Secretary of Health and Human Services Advisory Committee on Genetics, Health and Society (SACGHS), the Association for Molecular Pathology (AMP) addressed three areas: Comparative Effectiveness Research (CER), evidence for coverage of genetic and genomic tests, and gene patents.

AMP first summarized the organization's recent extensive comment letter to the Federal Coordinating Council on Comparative Effectiveness Research:

• AMP encourages the development of a comprehensive infrastructure for CER and laboratory tests, which should include a panel of expert stakeholders with molecular diagnostics experience.

• AMP urges that funding for large, carefully designed comparative effectiveness trials for molecular tests be coupled with funding for comparative effectiveness studies that complement randomized controlled trials by including patients who do not necessarily meet the inclusion criteria for prospective trials.
• AMP calls for funding to develop new reference materials and innovative testing methods to advance laboratory quality measures.

AMP next addressed the closely related issue of reimbursement, summarizing the organization's comments to the CMS MEDCAC. AMP maintains that the evidence required for coverage of most genetic and genomic tests should not differ from the requirements for other diagnostic tests.

Last, AMP referred to their extensive comments to the SACGHS draft report on gene patents and licensing practices. AMP believes that while the Draft Report raises many key questions, it misses an opportunity to more definitively explore the negative impact on public health that derives from exclusive and restrictive licensing practices, such as with the case of the genes associated with SMA and the Connexin-26, and Connexin-30 genes. AMP encouraged the Secretary's Advisory Committee to consider additional case studies that demonstrate this point.