Very Brief Blog: Some New Resources on LDT/IVD Legal Reform

Much has been written in the past several years on potential changes in the ways FDA handles LDTs and IVDs.   Currently, one of the top-ranked articles at 360DX (a sister publication to Genomeweb) is Adam Bonislawski's interview with ARUP's Jonathan Genzen.  (Here.)    The interview is subscription access, but in this blog I note that Genzen has written several open-access articles that present his extensive policy research.

Genzen 2019
Regulation of Laboratory-Developed Tests: A Clinical Laboratory Perspective.
Am J Clin Pathol 152:122-131, August 2019.
See open access article here.

Genzen et al. 2017
Laboratory Developed-Tests: A Legislative and Regulatory Review.
Clin Chem 63:1575-1584.  July 2017.
See open access article here.

While Genzen 2017 is obviously not quite as timely as Genzen 2019, the 2017 article includes some additional length and background, so the 2019 paper rests on top of it.

Genzen also participated in a subscription-access 2019 paper, Mohlman et al. (2019) Reliability and validity of proposed risk-stratification methods for LDTs.  Lab Med 50:194-201.  Here.

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A couple other resources

This blog today is far from comprehensive but two other papers of interest:

Although not open access, an older article that preserves the CAP 2011 era perspective is here:
Vance (2011) CAP Proposal for Oversight of LDTs.  Arch Pathol Lab Med 135:1432-5.

See also:
Thompson BM et al. (2016) Understanding the FDA's jurisdiction over LDTs, Divisions between FDA- and CLIA-regulated activities.  Clin Lab Med 36:575-85.

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VALID Act (aka FDA Reform 2019)

The most recent Hill proposal is the VALID act which incorporated FDA proposals to the Hill in Summer 2018. 

See IDSA's position here, CAP's collated recent positions here, a January 2019 review from McDermott Will & Emery here, AACC's collated recent positions here.

Numerous organizations recommended Congress move forward with VALID in May 2019, e.g. here.  ACLA press release here.  

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HHS Comment on VALID vs FDA Comment on DAIA

In August 2018, HHS issued a 59 page PDF of comments on the then-current reform bill, DAIA.  See blog here, and 59 page document here.  The 59-page document got a lot of attention and was a big push on the journey between DAIA and VALID.

In April 2019, HHS issued an 18-page PDF of comments on VALID.   Here.   It updates the HHS viewpoint on legislative reform into 2019, and I think this 18 page document in 2019 got a lot less attention than the 59 page document in 2018.