This @HHSGov memo posted by @politico gives the lab industry adminsitrative legal cover to deflect FDA premarket review. But once lab tests enter the market, the memo discusses a legal path @US_FDA can use to remove bad actors. politico.com/f/?id=00000174… @davidalim Look, even in its statement in August, @HHSGov said @US_FDA will not require premarket review of lab tests. It didn't say anything about all other levers the agency can use to rein in bad actors...including post-market actions. hhs.gov/coronavirus/te…

@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's the FAQ: hhs.gov/sites/default/… 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.

Wrong. @US_FDA has for more than 20 years asserted it has jurisdiction over lab-developed tests. Just last year, the FDA under the Trump Administration warned a lab doing genetic tests for drug response (Inova) and maintained it can regulate LDTs when there's a pub hlth concern

https://twitter.com/atrupar/status/1235247083411648513

And read FDA's actual statement from Saturday. The agency explains that while it is allowing labs to validate and perform coronavirus testing before they submit for an EUA, the EUA standards aren't changing. Labs still have to submit for EUA and notify FDA. Thus FDA has authority

How can @23andMe claim its tests are better b/c they are @US_FDA approved, when the FDA says some of these tests (i.e. limited BRCA test) must be confirmed by another test that most likely will not be FDA approved?

https://twitter.com/annewoj23/status/1228192697715834881

@US_FDA approval is a poor measure of @23andMe's test quality as long as regulations are inconsistent. And yes, a lot of people have speculated that the disagreement between the lab community and FDA over regulation would be resolved "any day" since...the 1990s.

@Color to Use $4.6M @NIH Grant to Build @AllofUsResearch Genetic Counseling Resource
genomeweb.com/research-fundi… @Color @NIH @AllofUsResearch Color will develop edu materials, work with a translation service to deliver telegenetic counseling in more than 200 languages, in addition to having English- and Spanish-speaking counselors, provide support from pharmacists, and connect participants to local healthcare services

Highlights from my latest @GenomeWeb piece on @US_FDA's stepped up actions on PGx testing genomeweb.com/regulatory-new… @US_FDA appears to be going down a list of PGx labs, sending them letters that reference an earlier warning letter to @INova and asking labs to interpret what that means for them from a regulatory standpoint, but provides no guidance as to what specific actions they must take.

I wrote about why pharmacogenetics and legal experts feel the @FDAcdrhIndustry's rationale for warning @InovaHealth over its tests is problematic: genomeweb.com/clinical-lab-m… In the letter, @FDAcdrhIndustry suggests that the agency considers drug/gene relationships to be "established" only when they are described in FDA-approved drug labeling.

Whenever I get the chance, I ask @FDAcdrhIndustry what, if anything, they plan do about the lack of oversight of third party genetic data interpretation companies. Every year, I get the same non-answer. Hope the agency is paying attention to your story, @MyGeneCounsel.

https://twitter.com/MyGeneCounsel/status/1095443568972496897

genomeweb.com/molecular-diag…

At the #PMConf this week, there was an informal audience survey of how many had gotten WGS. More than usual in that audience at Harvard Med School raised their hands. But those who didn't were asked what price point was acceptable to them. Again, in an audience of life sciences experts, a lot of people seemed comfortable with a $500 or lower than $1,000 price tag.

An important @nytimes OpEd about the no man's land consumers can fall into with DTC genetic testing. The OpEd dubs this market a "regulatory Wild West." It is for consumers but news outlets can help by describing the regulatory landscape accurately. nytimes.com/2018/09/15/opi… If we remember the history of FDA regulation against the DTC genetic testing industry, recall that the agency didn't just stop Pathway and 23andMe, but for a number of years shut down the entire segment of health related DTC genetic testing.

Joe Kernen of CNBC: This (Health Nucleus) is going to be bigger than @theranos
(audience shocked laughter)
@JCVenter: Well I am not as good looking but our data is real. #HealthyReturns Venter shared anecdotes of patients who benefitted from Health Nucleus at CNBC #HealthyReturns. But that's not the same as data from a study comparing those going thru Health Nucleus vs those receiving standard care. But @JoeSquawk was a bit starstruck and didn't get into that.

Nevada health project moves to exome sequencing 40K participants via @my_helix after pilot phase, in which 10K enrolled in 48 hrs and submitted DNA for genotyping @23andMe in 60 working days. genomeweb.com/genetic-resear… Under the latest arrangement, participants get a free app from @my_helix marketplace, and a Helix account with which they can buy more apps, opening up the chance for Helix to garner 40K paying customers. Helix declined to share current customer numbers.