NEW YORK, Feb. 25 (GenomeWeb News) - Steve Gutman, the director of the US Food and Drug Administration's Office of In Vitro Diagnostic Device Evaluation and Safety, has asked Correlogic Systems to discuss the marketing of the company's test for predicting ovarian cancer, GenomeWeb News has learned.
In the letter to company president Peter Levine, which is dated Feb. 18, Gutman said the test is a device and may be subject to the agency's premarket review requirements.
The test, called OvaCheck, was developed by Correlogic and scientists at the National Cancer Institute and the FDA, and is licensed to clinical lab giants Quest Diagnostics and LabCorp.
Correlogic executives were unavailable for immediate comment, the company said.
Click here to view a copy of the letter, which is posted on the FDA website.