Discoveries in Health Policy

Ideas for or from an evolving healthcare system

 

AI History You Can Use: Relive Amazing 2007-2010 Debates about FDA, LDT, CDX
2026-03-12 20:21 UTC by Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.com

In the past couple years, we've lived through FDA regulation of LDTs, court cases, and expanding capabilities of genomic diagnostics, many of them LDTs. However, it's worth while to recall a period 2007-2010, when a PGx test to predict rituximab responders led to pushback from Genentech against LDTs, a Citizen's Petition to FDA, and a National Academies review in 2010. The PGX FCGR

      

 

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