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The test measures the level of antibodies to the spike protein of the virus and can be used to establish immunity and vaccine efficacy.
The assay is Guardant Health’s first commercially available product for clinical management of early-stage tumors and is initially focused on colorectal cancer.
The company is planning to commercialize its cancer early detection technology initially in lung cancer and is working with NYU researchers to explore future expansions.
The 30-minute test can be used on samples from males and females in settings operating under a CLIA certificate of waiver.
The tests are expected to become widely available to consumers through supermarket chains, drug stores, pharmacies, and online sales starting March 6.
R-Pharm, Illumina's strategic partner in Russia and the Commonwealth of Independent States (CIS), led the registration process with the Russian regulatory agency.
Based on full approval from the FDA based on the Phase III CROWN trial, Pfizer can now market the drug as a front-line option for ALK-positive NSCLC patients.
The company's cartridge for pneumonia for the Unyvero system is under review and pending approval by Chinese regulators.
The rapid, chromatographic immunoassay qualitatively detects the nucleocapsid protein of SARS-CoV-2 from nasal swabs and is CE marked.
Adaptive Cofounder and Chief Scientific Officer Harlan Robins compared the launch of the test to the unveiling of the Tesla Roadster electric sports car.