FDA officials said at ACLA's annual meeting that the agency's efforts to balance rapid test access with safety during the coronavirus crisis carries lessons for the oversight of all tests.
The company attributed its revenue shortfall to billing issues in the prenatal testing business and announced that CFO Bryan Riggsbee will be interim CEO.
The FDA has been prodding labs performing pharmacogenetic testing, and software firms providing reports from such testing, to undergo regulatory review.
The pharmacogenetic test, which runs on a platform from British company Genedrive, will be tested in two neonatal intensive care units in Manchester and Liverpool.
The owner is accused of falsely billing Medicare for cancer genomic testing and pharmacogenetic testing that regularly exceeded $12,000 per beneficiary.
Despite the step-up in FDA action against labs offering PGx tests, the success of these programs suggests that access to them isn't being stifled as some feared.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.
