FDA raises regulatory issues: validity testing indefinitely delays OvaCheck release.(News)

Expanded validity testing has delayed the release of OvaCheck, a new ovarian cancer screening test, and a government inquiry may complicate the test's journey to market.

The blood test, which identifies a specific pattern of metabolites associated with even early-stage ovarian cancers, was slated for release at the end of last month. But the release date is now impossible to predict, said Peter Levine, CEO of Correlogic Systems Inc., the company developing OvaCheck.

"We are validating the test with a large number of samples, and that is a process that takes time," Mr. Levine said in an interview. "I can't speculate on how long that could take."

Correlogic has licensed the test to both LabCorp and Quest Diagnostics; both labs are running internal validation studies on more than 1,000 blinded samples--a number that has doubled since the beginning of the year.

Complicating OvaCheck's development is a Feb. 18 letter from Dr. Steven Gutman, director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety. The letter, addressed to Mr. Levine, states that FDA has reviewed reports that Correlogic is contemplating the commercial distribution of a test intended for use in detecting ovarian cancer. Under federal law, such tests are considered diagnostic devices and fall under FDA regulation.

The letter asks Mr. Levine to meet with FDA officials "to discuss the nature and appropriate regulatory status of [the test] and the least burdensome ways that Correlogic Systems may fulfill any premarket review requirements that may apply."

Correlogic has characterized the test as a screen for women at high risk of ovarian cancer, not a diagnostic device.