MedCity News eNewsletter, Diagnostics

Other diagnostic companies utilize regulatory loopholes, not just Theranos

Several diagnostic companies use the "laboratory developed test" loophole to avoid regulation and market tests without FDA approval, for better or worse.

Theranos has received plenty of media attention and a fair amount of heat concerning it’s unapproved finger-prick blood test and its pending FDA approval. Most of that very directed focus has been as a result of Elizabeth Holmes’ presence as a prominent public figure. But other diagnostic companies have operated the exact same way – namely utilizing the “laboratory developed test” (LDT) loophole.

Some other diagnostic companies providing cancer tests using the LDT loophole include Pathway Genomics, Admera Health and Strand Life Sciences. The Verge‘s Arielle Duhaime-Ross outlined how these particular companies used the same route, essentially avoiding pre-market verification by doing their own on-site testing, and how it was technically legitimate, despite the fact that the FDA has been looking to regulate LDTs, especially with potentially deadly diseases like cancer.

Basically, as far as these companies are concerned, if their laboratories pass inspections by federal regulators, they can keep launching new unapproved tests.

One benefit of the LDT loophole is the opportunity to keep methods secret – there’s no reason companies would need to publish data.

“Their intellectual property is know-how and that’s something that they want to keep as trade secrets,” Michael Murphy, president of Conatus Consulting, a medical device regulatory consulting firm, told Duhaime-Ross. “They wouldn’t want to publish the formula for their tests, because then their competitors would see it.”

Strand Life Sciences has marketed its StrandAdvantage test that is designed to detect genetic mutations that drive cancer growth in just a few days. Duhaime-Ross reported that there were no apparent studies published in peer-reviewed journals that indicate the efficacy of these tests. And a Strand Life Sciences press contact simply said they plan to do clinical studies.

Pathway Genomics, which has released a blood test said to detect cancer cell DNA and has not sought FDA approval, is another example of this approach. Duhaime-Ross wrote:

But when The Verge got in touch with Pathway Genomics, the company couldn’t provide any data to support the validity of the $699 test. And the reason it couldn’t provide the data isn’t because the company wanted to protect some trade secrets. Pathway Genomics had actually decided to start selling their test without making sure it worked, first. We know this because we asked Glenn Braunstein, chief medical officer at Pathway Genomics, about it. He told us that the company has yet to complete a trial that could show that people who test positive for markers of cancer in their blood actually do develop cancer.

And there is Admera Health, which has developed the genetic test called OncoGXOne that according to a press release detects “potentially actionable cancer-driving [genetic] mutations, which can be targeted by specific therapies.”

But, much like Theranos, Admera hasn’t bothered to publish studies that support their claims in peer-reviewed journals. So, if a patient wants to verify that this test really can detect “64 genomic alterations critical to cancer” in just 10 days, she has no resources to fall back on; she has to take Admera’s word for it.

Admera collaborates with Rosetta Genomics to sell and market this test, which still falls into the LDT rules.

How this LDT loophole really affects patients down the road is questionable without clinical trials and the opportunity for peer-review. It seems that making sure companies don’t get the media scrutiny that Theranos has might be the ticket for under-the-radar profits to some degree. The challenge now is finding a solution between the FDA and these companies who (hopefully) just want to further development and really make a difference for patients.

Photo: Flickr user rosemary

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