The team and its partner SpectraPass are creating an assay with the intent of obtaining Emergency Use Authorization from the US Food and Drug Administration.
FDA Clears Digital Pathology System From Leica Biosystems
The digital pathology system can be used for primary diagnosis as a result of the 510(k) clearance, which followed a multicenter study conducted at five clinical sites.
The company published data from a 1,102-patient trial that found that amino acid markers could be useful for diagnosing the condition in a subset of patients.
Study Describes Design, Validation of Foundation Medicine's Blood-Based TMB Test
Researchers showed, retrospectively, that using a cutoff of 16 circulating DNA mutations they could identify patients who were more likely to respond to immunotherapy.