Throwing yet another wrench into plans to release a mass spec pattern-based ovarian cancer test for home brew use, the FDA sent twin letters last week to Quest Diagnostics and Laboratory Corporation of America. The letters warned that the test these two companies licensed from Correlogic Systems for possible home brew use may be subject to premarket review.
This time, the letter came both from the Office of In Vitro Diagnostic Devices, and from the Centers for Medicare and Medicaid Services, which regulate reference laboratories that conduct home brew tests under the Clinical Laboratories Improvement Amendments of 1988, or CLIA. “[W]e are uncertain if your ovarian cancer offering will be subject to regulation only by CMS, under [CLIA], or whether it may also require premarket review by the FDA under the Federal Food, Drug, and Cosmetic Act,” read the letter, dated March 2. The letter was signed by both Steven Gutman, director of the OIVD, and Judy Yost, director of CMS. A similar letter, sent to Correlogic Systems on Feb. 18 (see PM 2-27-04, 3-5-04), was signed only by Gutman.
Correlogic, of Bethesda, Md., developed a pattern recognition algorithm for the analysis of SELDI-produced mass spectra to detect patterns in serum indicative of ovarian cancer, and published the results in the Lancet in February 2002. The platform was developed in collaboration with Emanuel Petricoin and Lance Liotta of the NCI-FDA clinical proteomics program, who are now working on a different version of a pattern test. Correlogic signed an agreement in November 2002 with Quest and LabCorp for the development of a homebrew ovarian cancer test based on the algorithm.
Diagnostic tests qualify as home brews if they are conducted in their entirety only at CLIA-approved reference laboratories. Both Quest and LabCorp are CLIA-approved, and both already offer traditional ovarian cancer screening based on the detection of CA125. This status would normally clear the way for them to administer a new home brew test for ovarian cancer without having to worry about the OIVD. In order for that to be the case, however, a test has to first qualify as a home brew, which Correlogic’s might not (see PM 2-27-04).
But even if the test were determined not to qualify for home brew status, Quest and LabCorp would not ordinarily be held liable for this mistake, according to several FDA regulation consultants. The creator, they said, rather than the end-user of such tests normally bears the brunt of the responsibility for making sure that a device is approved. This, they said, was probably why the letter was first sent to Correlogic, and not to Quest and LabCorp.
But the bottom line is that it is impossible to predict what the FDA will decide to do in a novel situation like this one, these consultants said. “Could the FDA come into [see] Quest and LabCorp? That’s always possible,” Timothy Alcorn of the regulatory consulting firm Biotech Consultant told ProteoMonitor before the newest letters were publicly released. “That’s not normally done, but that’s always possible. And since that is possible, I would imagine [Quest and LabCorp] would be concerned in that regard.”
Pam Sherry, a senior vice president for LabCorp, told ProteoMonitor two weeks ago that current plans were to put out a test based on Correlogic’s technology “on or around April 1.” With the FDA now on LabCorp’s tail as well, the company would be hard-pressed to make that deadline.