Oncology News Updates

FDA Questions LabCorp in its Ovarian Cancer Test Service

The Pink Sheet Daily
Aug 19, 2008

FDA sent a letter charging clinical laboratory giant Laboratory Corporation of America with marketing a test for ovarian cancer without proper clinical validation. The communication, dated Aug. 7, is a rare instance of FDA getting involved in a clinical laboratory's efforts to offer a new diagnostics service, but appears to reflect previously signaled but controversial plans by the agency to begin regulating lab-developed tests in certain cases.

The letter was posted on the Web site of the Office of In Vitro Diagnostic Device Evaluation and Safety on Aug. 15, but was removed from the site yesterday afternoon. OIVD Director Steve Gutman denied a request by Health News Daily for a comment on the letter.

"Based on our review of your promotional materials and the research publication cited above, we believe you are offering a high risk test that has not received adequate clinical validation, and may harm the public health," writes Gutman to LabCorp CEO David P. King. "We would like to discuss with you your offer of this test, and any validation strategies you have undertaken...."

The letter addresses the OvaSure ovarian cancer screening test, developed by researchers at Yale University and launched as a test service by LabCorp in June. OvaSure simultaneously tests for six proteins associated with ovarian cancer to detect early-stage disease in high-risk women, according to LabCorp.

LabCorp says the test discriminates between disease-free women and stage I-IV ovarian cancer patients with a specificity of 99.4% and a sensitivity of 95.3%. But FDA suggests in the letter that those numbers are based solely on a study published by Yale researchers in February that compared results from women recently diagnosed with ovarian cancer to a control group of healthy women.

The data results from "two populations that are strongly clinically biased for being healthy and normal, and for having already experienced ovarian cancer," Gutman writes. "Based on the available information, we do not believe the scientific community would consider the reported study sufficient to establish performance characteristics of a test in 'high-risk women who might have ovarian cancer,' i.e., in a clinical setting, as claimed in your intended use and promotional materials."

In a description of the letter that appeared on its Web site, FDA says LabCorp is marketing OvaSure "without approval or clearance from FDA, in violation of the law."

Sign Of New IVDMIA Policy In Action?

Clinical laboratories, such as LabCorp labs, that are certified by CMS as "high complexity" have traditionally not been subject to FDA pre-market or post-market requirements for so-called home brew tests, which are developed by the laboratory for in-house use as a test service.

FDA says it has simply been exercising enforcement discretion for lab-developed home-brew tests, but since 2006 it has proposed plans to end that policy for a certain class of products - called in vitro diagnostic multivariate index assays (IVDMIA) - that use complex data analysis to translate measurements of multiple analytes (such as genes or proteins) into a diagnostic or prognostic score.

Under a draft guidance issued in 2007, lab-developed IVDMIAs would in many cases need 510(k) clearance or PMA approval, and would have to comply with device post-market manufacturing and reporting requirements.

Laboratories and smaller diagnostic companies, which often view home brews as an important stepping stone for getting products on the market, strongly oppose the policy shift (Health News Daily, Aug. 29, 2007). More established diagnostics manufacturers, however, are more supportive of the new approach because of its potential to level the market barriers between home brews and packaged test kits.

If the IVDMIA policy is finalized in the form issued last September, labs would be given up to 18 months of additional freedom from device regulation enforcement for home brews.

The letter to LabCorp does not explicitly require the firm to seek a 510(k) or PMA, but invites the company to discuss "validation strategies."

LabCorp did not answer a request for comment.

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