Mind to Market

Tuesday, December 16, 2008

Genentech Seeks to Tame Molecular Diagnostics

Genentech has filed a Citizen Petition with the FDA in an effort to encourage the agency into tighter regulation of molecular diagnostic tests according to a recent article in GenomeWeb Daily News. A number of companies currently manufacturer these tests some of which test for the overexpression of the HER2 protein in breast cancer tissues, an indication that the patient would benefit from the application of Genentech’s cancer drug Herceptin.

Since the prescription of Herceptin requires that patients be tested for their HER2 expression it is understandable that Genentech be concerned about the accuracy and quality of these tests. Although some diagnostic companies, such as the Danish firm Dako have voluntarily submitted to FDA approval process, it is not yet a requirement since the tests are considered a laboratory-developed test (LDT) and therefore outside of FDA regulation. Several other manufacturers, such as Clinical Data and Genomic Health, currently market tests that have not been approved by the FDA. These manufacturers do claim to be in compliance with CLIA regulations.

Clinical Data has already replied to the Citizen Petition, opposing it and stating that the FDA approval process would impose “excessive or inappropriate regulation” which would be “a powerful disincentive to the development of innovative healthcare products.”

New molecular diagnostics companies are on the rise, riding the wave of the coming age of personalized medicine. Ultimately it is the decision of the treating physician to determine which diagnostic test to prescribe. Equally important to the adoption of the tests is the rate at which insurance companies will reimburse for the tests.

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