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FDA Sends Letter to Correlogic: Premarket Review May be Required for its Ovarian Test

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In a public move toward regulating the marketing of proteomics pattern-based diagnostic tests, the FDA last week sent a letter to Correlogic Systems, warning the company that premarket review requirements may apply to the planned commercialization of an ovarian cancer test based on its technology (Click here to view the letter).

“We have no record that such a test has been the subject of premarket review by FDA,” read the letter, dated Feb. 18 and signed by Steven Gutman, director of the Office of In Vitro Diagnostic Device Evaluation and Safety. “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 Correlogic Systems may fulfill any premarket review requirements that may apply.”

Gutman would not elaborate on what premarket review may be required, or on what actions Correlogic should have taken. “I can’t comment on ongoing compliance activity,” he told ProteoMonitor.

Correlogic, of Bethesda, Md., developed the pattern recognition algorithm for a ProteinChip/SELDI-based ovarian cancer detection platform developed in collaboration with Emanuel Petricoin and Lance Liotta of the NCI-FDA clinical proteomics program, and published the results in a February 2002 Lancet paper. Correlogic signed an agreement in November 2002 with Quest Diagnostics and Laboratory Corporation of America Holdings for the development of a homebrew ovarian cancer test based on the algorithm.

Peter Levine, president and CEO of Correlogic, in an e-mail described the nature of the agreement as a “three-way development and license agreement,” and said that what was licensed was “the hidden patterns process and related technologies for use in development of an ovarian cancer test.” Annette Fribourg, a Correlogic representative, told ProteoMonitor that Correlogic has “not had the meeting with the FDA yet, but we will meet and we are happy to do so.” She would not comment further on the letter.

Neither Quest nor LabCorp has yet made the test commercially available, but Pam Sherry, a senior vice president for LabCorp, told ProteoMonitor that current plans are to put out a test “on or around April 1.” Sherry declined to comment on the letter.

Petricoin, who is officially affiliated with the Center for Biologics Evaluation and Research at the FDA, declined to comment on the letter except to say “that I am not involved and was not involved in this at any level.” Petricoin and Liotta have said they are currently gearing up to conduct clinical trials on more recently obtained patterns and that they are working closely with the FDA, seeking eventual 510(k) approval for a test to launch outside of the homebrew classification (see 2-13-04).

It was not entirely clear why the FDA directed its letter only to Correlogic and not to LabCorp or Quest, but from the letter it appears that the actual licensing of the technology may be the point of concern for Gutman. “The [OIVD] has reviewed reports indicating that Correlogic Systems is contemplating or has begun the commercial distribution to two major commercial laboratories of a test intended for use in detecting ovarian cancer,” the letter read. It went on to point out that such a test classified as a device and therefore fell under the OIVD’s domain.

Alan Kusinitz, a managing partner at SoftwareCPR, an FDA software regulation consultancy, told ProteoMonitor’s sister publication, BioInform, that “software can be part of a medical device, and as such can be regulated.” He said that in this sort of case, the FDA regulates mainly the “manufacturer” of the diagnostic device, rather than the end user, which may be why the letter was sent to Correlogic.

Gary Samuels, spokesperson for Quest Diagnostics, said that no decision has yet been made about whether a homebrew ovarian cancer test based on Correlogic’s technology “will be available ever” at Quest. He said that each of the three involved companies — Correlogic, LabCorp, and Quest — were independently conducting validation tests now on a “large collection” of specimens, and that initial analysis has already been completed on 750 specimens from high risk women provided by the NCI-sponsored National Ovarian Cancer Early Detection program. Some of the women who provided the specimens went on to develop ovarian cancer and some did not. The test that Quest would offer, should the company commercialize it, would be done using mass spec at Quest’s laboratory on blood specimens sent there, Samuels said, but “this test doesn’t exist — we’re speculating about how a test might work if it’s ever offered.” Sherry also said that tests would be performed at LabCorp, but neither Sherry nor Samuels could confirm that analysis would happen entirely at the lab.

Homebrew tests do not require FDA approval so long as every part of the test is conducted only inside a licensed clinical reference laboratory. If any component of the test is done outside of the facility, the test may not qualify as a homebrew. In addition, the technology involved in the test must first qualify for the exemption.

In a blow to Roche Molecular Diagnostics last October, Gutman sent a letter to Roche saying that its AmpliChip, a diagnostic DNA microarray intended for detection of genetic polymorphisms with relevance to drug metabolism, did not qualify as an ASR, a type of homebrew technology (click here for the letter). In the letter, Gutman said that the chip’s intended use was “of substantial importance in preventing impairment of human health” and therefore was not exempt from premarket notification requirements according to FDA guidelines (see sister publications SNPTech Pharmacogenomics Reporter, 11-6-03 and BioArray News, 11-5-03 for details).

Kusinitz said that Correlogic’s algorithm could meet with the same problem, because its use in the context of a test could significantly affect human health. “Cancer detection, if it doesn’t work properly, has some indirect potential to harm a patient due to a delay in treatment,” he said.

He added that should it be determined that pre-market approval is required for the test, “the best case [for approval] is six months.”

— KAM

 

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