The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.
The test is for monitoring treatment response in chronic myeloid leukemia and uses a new Droplet Digital PCR instrument.
The assay's CE marking permits its use for the early diagnosis of HIV-1 in infants and for measuring viral load and disease progression using dried blood spot samples.
Proficiency testing providers told CMS last year that an update to the rule, which has not been changed since 1992, is long overdue.
The assay, which uses the Bioneer ExiStation molecular diagnostics instrument, was also recently registered for purchase by the Global Fund.
The federal government said GenomeDx billed Medicare for its Decipher Biopsy prostate cancer genome classifier on behalf of patients who didn't need the test.