The Food and Drug Administration has sent Pathway Genomics a warning letter that expresses concern over its new liquid biopsy test for cancer, and that it’s being marketed with a direct-to-consumer bent. Indeed, the FDA has called the diagnostic “a high risk test that has not received adequate clinical validation and may harm the public health.”
The FDA said it has reviewed its records and hasn’t found any approvals or clearances for the diagnostic, which made waves earlier this month when Pathway touted it was the first liquid biopsy test to hit the market.
Its CancerIntercept Detect test, which identifies circulating tumor cells in high-risk patients, is of primary concern to the FDA. It’s being marketed with a clever subscription model – for about $299 per test, users can take the test four times a year to regularly check for cancer.
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Pathway has posted a white paper on its site that details the rationale for why its liquid biopsy test is sufficiently validated. But the FDA writes:
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.
As GenomeWeb writes, this isn’t the first time that Pathway’s marketing tactics have fallen in FDA crosshairs:
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.
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KevinMD just posted a skeptical article on the ultra-rapid release of Pathway’s liquid biopsy testing, writing:
Simply stated, our technology and rush to get new tests to market — even before we have a basic understanding of how to use those tests to improve the health of consumers — has outstripped our scientific understanding, and we ignore the implications at our own peril.
The piece examines why it’s unrealistic that Pathway has accomplished what it claims it has – which strengthens the FDA’s claim that it may indeed be too soon to market such a test directly to patients.
There are two reasons, according to the KevinMD piece. Firstly, though it’s possible to detect circulating tumor DNA, it’s still too early in the game to accurately pinpoint which kind of cancer this genetic material is linked with.
Secondly, our bodies are constantly creating cells that could become cancerous – but our immune system typically takes care of them before they become malignant. But if a test picks up on these cancerous non-cancers, they could very well create false positives.
Notably, this is the very reason that Pathway Genomics was marketing its cancer screening test to high-risk patients exclusively, Glenn Braunstein, the company’s chief medical officer, said in an interview earlier this month.
The KevinMD piece brings up a third point:
Another question is what we do if we found DNA fragments in someone who had no clinical evidence of cancer? What if we do additional scans and blood tests and don’t find a cancer? Depending on the findings, DNA mutations in cancer aren’t necessarily specific to one organ or tissue. Or if it is relatively specific, what if we do a test such as a colonoscopy on suspicion of colon cancer and don’t find anything? How many scans, how many colonoscopies, how often do we follow-up? Who knows? I certainly don’t, and neither does anyone else. And in the process, aside from doing all these studies, what if we cause an adverse event and cause harm?
[IMAGE: Flickr user Rosemary]
