The bill delays PAMA price cuts until Jan. 1, 2027 and updates the data collection period to be used to establish 2027 lab rates from 2019 to 2025.
NEW YORK – T2 Biosystems said on Tuesday that it will immediately wind down its operations and liquidate the company.
The agency said that impurities in the company's Safe-T-Fill EDTA tubes may be related to false positive lead testing results reported by users of Magellan Diagnostics' lead detection tests.
The 15-minute test runs on the Diasorin Liaison Nes system and obviates the need for molecular confirmation of negative rapid immunoassay results.
The coalition will invest the money in six collaborative research projects focused on pancreatic, ovarian, and esophageal cancers, as well as cancer predisposition syndromes.
The test integrates the measurements of five proteins to assess if patients have the brain pathology characteristic of Alzheimer's disease.
The newly formed coalition aims to increase access to noninvasive diagnostics for metabolic dysfunction-associated steatotic liver disease (MASLD).
Last week, readers were most interested in a story about whether labs who want FDA authorization of their LDTs can send the tests to the agency for review.
While labs overwhelmingly welcomed the ruling, it could make it more difficult for firms that want FDA's imprimatur for LDTs ...
The submission is focused on the test performance and safety results from more than 25,000 patients in the Pathfinder 2 study and from the first year of the NHS-Galleri study.
The investment bank said that the company's recent organic growth is sustainable and noted consumer momentum and traction with advanced tests.
The test can be used to detect HDV infection, a particularly dangerous coinfection that can occur with hepatitis B virus.
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