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FDA Questions Whether Genomic Health s Oncotype Dx Should Have Obtained Pre-Market Approval

NEW YORK, Jan. 30 (GenomeWeb News) - The US Food and Drug Administration has asked to meet with Genomic Health CEO Randy Scott to discuss the company's Oncotype diagnostic for breast cancer, according to an FDA letter.

In the letter, dated Jan. 23, the agency's Office of In Vitro Diagnostic Device Evaluation and Safety stated that the FDA has no record of a pre-market review of the test. It asked that Genomic Health set up a meeting with OIVD at its "earliest convenience to discuss the nature and appropriate regulatory status of your technology, and the least burdensome ways that Genomic Health may fulfill any premarket review requirements that may apply."

Genomic Health said on Friday it intended to comply with the letters request for a meeting "in the near future."

 

OIVD "has reviewed reports indicating that Genomic Health is marketing the Oncotype DX ... [as one that predicts] distant disease recurrence ... [and asseses] ... a patient's benefit from certain types of chemotherapy. Under section 201(h) the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. § 321(h)), any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis of disease or other conditions is a device.

 

"We have no record that such a test has been the subject of premarket review by FDA," according to the letter. "We invite you to meet with us at your earliest convenience to discuss the nature and appropriate regulatory status of your technology, and the least burdensome ways that Genomic Health may fulfill any premarket review requirements that may apply."

Letter can be found 

here.
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