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If the bill passes in its current form, PAMA reporting would be delayed until January 2022 and rate cuts scheduled for 2021 would be put off to 2022.
Two recent acquisitions have resulted in the swift launch of two assays, one for the clinic and another for research use, as the firm's original test finally nears validation.
The firms are developing a testing system that involves drawing fingertip blood and doing routine testing in Babson's CLIA-certified laboratory.
The firm is planning a prospective trial for the test after results in a small retrospective study showed good performance in identifying cancers and precancers.
The ID Now COVID-19 test is the second assay from the company to receive EUA from the FDA, following the same designation issued to the Abbott RealTime SARS CoV-2.
The company has issued a call for the 2,500 independent MDx labs across the US to join together in an effort to double SARS-CoV-2 testing capacity.