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@HHSGov recently added an #LDT FAQ to the statement on its website that @US_FDA cannot require premarket review of LDTs w/out notice-and-comment rulemaking. Here& #39;s the FAQ: https://www.hhs.gov/sites/default/files/laboratory-developed-tests-faqs.pdf">https://www.hhs.gov/sites/def...
In the FAQ, @HHSGov states that "although FDA has asserted the authority to [mandate premarket review of LDTs], this requirement has in fact almost never been enforced. It was only being enforced during public health emergencies." This, in fact, is false and misleading.
![In the FAQ, @HHSGov states that "although FDA has asserted the authority to [mandate premarket review of LDTs], this requirement has in fact almost never been enforced. It was only being enforced during public health emergencies." This, in fact, is false and misleading.](https://pbs.twimg.com/media/Eg2wSigWoAMKvPI.jpg "In the FAQ, @HHSGov states that \"although FDA has asserted the authority to [mandate premarket review of LDTs], this requirement has in fact almost never been enforced. It was only being enforced during public health emergencies.\" This, in fact, is false and misleading.")
As I recently wrote in @GenomeWeb, FDA under multiple presidents — George W. Bush, Barack Obama, & Donald Trump — has maintained that it has legal authority to regulate all diagnostics: IVDs performed at many labs and LDTs developed & performed in 1 lab. https://www.genomeweb.com/molecular-diagnostics/stakeholders-scramble-predict-impact-hhs-move-limiting-fda-ability-regulate#.X06ftshKg2w">https://www.genomeweb.com/molecular...
There& #39;s a lot of nuance missing in the HHS FAQ. To understand this issue, it& #39;s important to start off with a definition of LDTs. The FDA has defined LDTs as tests developed, validated, and performed in a single lab.
However, the industry& #39;s definition of an LDT has not always aligned with the agency& #39;s definition. And this tension has resulted in a lot of FDA regulatory activity.
In Oct. 2008 (under George W. Bush admin) FDA sent a warning letter to LabCorp for marketing an ovarian cancer test developed at Yale. That, the agency said wasn& #39;t an LDT, b/c not developed and performed in the same lab; many in the lab industry disagreed https://www.genomeweb.com/archive/fda-warns-labcorp-about-misbranded-ovasure-test#.X06i1shKg2x">https://www.genomeweb.com/archive/f...
In 2010 (Obama admin), FDA started regulating direct-to-consumer genetic testing companies saying these aren& #39;t LDTs. But, companies had launched these tests w/out seeking FDA premarket review precisely b/c they assumed what they were providing were LDTs https://www.genomeweb.com/diagnostics/fda-warns-dtc-genomics-firms-genetic-tests-are-not-ldts-may-need-clearance-or-approval#.X06m1chKg2w">https://www.genomeweb.com/diagnosti...
HHS states in the FAQ that DTC tests aren& #39;t LDTs. Those in the lab and pathology community historically against FDA regulation of LDTs tend to agree that DTC genetic tests aren& #39;t LDTs.
But then again, new consumer facing labs have tried to distance themselves from DTC label by employing 3rd party physician networks to approve customer test orders. Many feel there& #39;s not much practical difference btw a person ordering online & a doc they never met ordering
Are LDTs sold to consumers online not "distributed" tests simply b/c test orders are cleared through 3rd party doc networks a/c to HHS? (Common argument: when a doc orders a test, even if not pts own doc, its out of FDA jurisdiction b/c FDA can& #39;t regulate practice of medicine)
The FDA has, since at least 2011 (under Obama), consistently regulated companion diagnostics (LDTs & IVDs) which are tests used to determine whether a patient should or should not receive a specific drug. Final guidance: 2014 https://www.fda.gov/media/81309/download">https://www.fda.gov/media/813...
Finally, the agency spent much of 2019 (under Trump admin), going after labs performing pharmacogenetic LDTs without the agency& #39;s approval/clearance. https://www.genomeweb.com/regulatory-news-fda-approvals/fda-stepping-actions-against-pgx-testing-forcing-some-labs-stop#.X06nbMhKg2y">https://www.genomeweb.com/regulator...
HHS action limiting FDA authority on LDTs has raised a lot of questions about what precisely is an LDT. Worth noting that FDA & industry have clashed over the line defining LDTs in the past, and HHS hasn& #39;t clearly delineated the line now. This FAQ raises even more questions.
