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Avapritinib is sold by Blueprint Medicines as Ayvakit for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation.
The lateral flow immunoassay is designed to rapidly detect and differentiate immunoglobulin M and G antibodies against SARS-CoV-2 in human serum and plasma.
Both of the RT-PCR-based tests use healthcare provider-collected samples and may be used by any lab CLIA-certified to perform high-complexity tests.
The second EUA for a test that targets the ORF1a and N genes is for an automated version of a manual test that had been granted EUA in August.
Promega will develop its microsatellite instability assay as a companion diagnostic for Incyte's anti-PD-1 drug candidate retifanlimab in endometrial cancer.
Visby's test is a fully integrated PCR device that detects SARS-CoV-2 RNA, while SNIBE's test comprises assays for two different antibodies against the virus.
The company received Emergency Use Authorization from the US Food and Drug Administration last month for a SARS-CoV-2 total antibody test.
The partnership will provide new point-of-care lipid testing devices to remote sites in Latin America, the Caribbean, and Asia-Pacific.
Healthcare providers need multiplexed tests that can differentiate the flu from the coronavirus so they can treat patients quickly and appropriately.
BillionToOne's test is based on the company's proprietary Sanger sequencing approach, while Sugentech's test detects antibodies against SARS-CoV-2.