Deadline to FDA Panel Accepting Comments on DTC Testing - May 2nd

The FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is accepting additional comments on issues concerning direct-to-consumer (DTC) tests that make medical claims. The panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics and makes appropriate recommendations to the FDA.

The NSGC is submitting comments on behalf of the Society, supporting the panel's recognition of genetic counselor involvement in the proper communication and interpretation of test results. The comments also address the panel's concern that there may be an inadequate number of genetic counselors available to provide services should it become required that the results of DTC tests that make medical claims be routed through a licensed genetics professional.

The NSGC currently has a task force working to develop an updated position statement on direct-to-consumer genetic testing. A draft of the statement will be circulated among the membership for comment in the coming weeks.

The NSGC encourages members to submit individual comments to the FDA advisory panel. Public comments due by Monday, May 2 and can be submitted online at:

http://www.federalregister.gov/articles/2011/04/01/2011-7708/molecular-and-clinical-genetics-panel-of-the-medical-devices-advisory-committee-notice-of-meeting#h-8

To read a summary of the Molecular and Clinical Genetics Panel meeting held on March 8-9, 2011, click here:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGenetics Panel/UCM246907.pdf

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