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The test, developed by the firms in six weeks, is part of a viral respiratory panel and runs on Bosch's point-of-care Vivalytic system.
Under the guidance, only the laboratory that developed the test can perform it if the lab is CLIA-certified to perform high-complexity tests.
Color is opening a lab dedicated to SARS-CoV-2 testing and adapting its software infrastructure to enable physicians to order tests and return results.
Sysmex anticipates delivering the kit to Japanese medical institutions this month for diagnosis of the SARS-CoV-2 infection.
Biocartis will lead commercialization in Europe as the exclusive distributor of the SeptiCyte Rapid test, while Immunexpress will lead commercialization of the test in the US.
The company's in vitro diagnostic qRT-PCR test detects viral RNA and targets three genes of the SARS-CoV-2 virus: the N, Orf1ab, and E genes.
The Primerdesign COVID-19 Genesig Real-Time PCR assay qualitatively detects SARS-CoV-2 nucleic acid in oropharyngeal swabs from suspected COVID-19 patients.
Labrador Diagnostics, a firm controlled by an investment group that acquired Theranos' IP, alleged BioFire's FilmArray products infringe two patents.
The test, authorized March 13, runs on the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument and targets three regions of the SARS-CoV-2 genome.
PreCheck Health has an initial order of 30,000 tests and will register the product in Ecuador. The two firms have a similar distribution agreement covering Russia.