The Association for Molecular Pathology and pathologist Michael Laposata, M.D., Ph.D., announced a favorable ruling in their lawsuit against the U.S. Food and Drug Administration over the regulation of laboratory-developed test procedures.
The Centers for Medicare & Medicaid Services (CMS) has updated chapter 6 of the State Operations Manual (SOM), and certain guidance memos are now expired.
Siemens Healthineers announced its Innovance Antithrombin assay has achieved FDA clearance for a new claim allowing it to be used as a companion diagnostic test for people receiving treatment with Qfitlia (fitusiran), a Sanofi hemophilia therapy.
