The US Department of Health and Human Services (HHS) said that it would use Fluidigm's saliva-based molecular SARS-CoV-2 test as part of a federal surge testing program.
Federal mandates requiring frequent SARS-CoV-2 testing for nursing home employees and significant purchases of rapid antigen tests from HHS have raised concerns about capacity.
The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.
While it is possible FDA could try to exert authority over such devices, observers suggest that past inconsistency and the recent HHS move make that unlikely.
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
