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FDA Sends Pathway Genomics Untitled Letter Over Liquid Biopsy Test

NEW YORK (GenomeWeb) – Pathway Genomics has received a letter (see PDF below) from the US Food and Drug Administration saying that it has concerns about a new liquid biopsy test for cancer offered by the company, as well as the way Pathway is marketing the test. 

Specifically, the agency has questions about CancerIntercept Detect, a test launched by Pathway earlier this month that detects tumor DNA in high-risk but otherwise healthy patients, according to a press release from the company. The liquid biopsy test analyzes the presence of 96 frequently occurring DNA mutations in nine cancer genes — though the FDA letter said that Pathway claims it can identify DNA mutations in 10 genes — and is priced as low as $299. 

Simultaneous to the launch of CancerIntercept Detect, Pathway made available CancerIntercept Monitor for monitoring patients with active or previously diagnosed cancer. However, the FDA letter does not mention that test. 

Among the concerns raised by the FDA is that it believes Pathway is using a "direct-to-consumer type model" to market the test. "Under this model, you ship blood collection tubes, a medical device, for use" with the test, the agency said, adding that it has no record of having approved, cleared, or listed the test. 

"We also have examined published literature and have not found any published evidence that this test or any similar test has been clinically validated as a screening tool for early detection of cancer in high-risk individuals," FDA said in its letter. 

Pathway has a white paper posted on its website, but, the FDA said, "It is unclear how the literature that you cited, addressing the presence of circulating tumor DNA (ctDNA) in already-diagnosed patients, is adequate to support the expansive claims of screening for early cancer detection using ctDNA in undiagnosed patients for up to 10 different cancers with the CancerIntercept Detect." 

The test, the agency said, has yet to be adequately clinically validated and "may harm the public health." 

It wants to meet with Pathway to discuss the test and the strategies used by the firm to validate the technology. The agency has given Pathway 15 days from receipt of the letter, which was sent Sept. 21, to reply to the agency and propose a timeframe for a meeting. 

In a letter posted on Pathway's website, the company said that it is "carefully considering the concerns of the FDA … and will be responding to [the] letter."

 The company added that physicians are involved "in the ordering, review, and follow-up of CancerIntercept testing," and believes that CancerIntercept Detect is a laboratory-developed test. As a "CLIA- and CAP-certified clinical laboratory, we are offering it as such," Pathway said. 

Pathway Chief Commercial Officer Ardy Arianpour told GenomeWeb two weeks ago when the CancerIntercept tests were launched that while patients can submit themselves as candidates for testing without first consulting their own doctors, the tests were not following a DTC model.

"The patient needs to provide a physician contact who will be contacted in the event of a positive result," he explained. Any positive results are then released to the chosen physician. Negative results get released directly to the patient and to the primary care physician.

It is not the first time Pathway has attracted the wrong kind of attention from the FDA. In May 2010, following a deal between Pathway and the drug store chain Walgreens to market Pathway's genetic test kits, the FDA sent a letter to Pathway saying that the kit requires marketing clearance from the agency. Eventually, Pathway abandoned the DTC model for the kits. 

In the fall of 2011, Pathway said that the FDA had "classified and registered" the kits as a Class I device, exempting the firm from having to meet more stringent requirements under 510(k) classification requirement. However, an FDA spokesperson told GenomeWeb at the time that registration is not the same as classification and the kits could, nonetheless, still need 510(k) clearance in order for the firm to market them.


An earlier headline inaccurately said Pathway received a Warning Letter from the FDA. The headline has been corrected to note that the firm received an untitled letter.

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