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While it is possible FDA could try to exert authority over such devices, observers suggest that past inconsistency and the recent HHS move make that unlikely.
Thermo Fisher said the assay is the first and, so far, only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC.
The company's contract with the NIH offered $12 million total and after initial test verification, Fluidigm will receive approximately $11 million.
The test is for use with the company's Liaison MDx instrument and can be used alone or with the Simplexa COVID-19 Direct kit.
BillionToOne's test is based on the company's proprietary Sanger sequencing approach, while Sugentech's test detects antibodies against SARS-CoV-2.
The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.
The RT-PCR test runs on Roche's automated Cobas 6800/8800 systems and is also available in countries accepting the CE mark.
The PCR-based test is designed to detect SARS-CoV-2 nucleic acid in a range of specimens including nasal swabs and bronchoalveolar lavage specimens.
Color Genomics' kit is designed for the unmonitored self-collection of nasal swab specimens for SARS-CoV-2 testing.
Created by BloodPAC members, the resource may serve as a set of generic analytical protocols to help define industry standards for developing liquid biopsy tests.