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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.
The firm will deploy 6 million of its rapid point-of-care molecular tests by March 2021, using the money to increase production capacity.
Reimbursement and liability issues will be impacted by FDA's decision, while LDT users could find it difficult to assess the quality of the new tests.
The awards will support clinical validation, manufacturing, and scale up for SARS-CoV-2 viral antigen and molecular detection.
The option was exercised under a multiyear contract between T2 Bio and BARDA valued at a total of $69 million if all options are exercised.
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.
Some lab experts say that Abbott's test is open to multiple variables, which could lead to improper use and incorrect test results.
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.