Asia/Oceania

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.

BillionToOne's test is based on the company's proprietary Sanger sequencing approach, while Sugentech's test detects antibodies against SARS-CoV-2.