Coronavirus company news summary - Harvard and MIT researchers develop saliva-based test - Qiagen’s portable antigen test gets FDA EUA - Verdict Medical Devices
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Coronavirus company news summary – Harvard and MIT researchers develop saliva-based test – Qiagen’s portable antigen test gets FDA EUA

09 Aug 2021

BD and CerTest Biotec have received the European CE mark for a molecular test designed to identify Alpha (B.1.1.7), Beta (B.1.351) and Gamma (P.1) SARS-CoV-2 variants. The VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit can be used with VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit or as a reflex test for variant detection from a positive sample.

A team of researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University, the Massachusetts Institute of Technology (MIT) and multiple hospitals in the Boston region have developed a saliva-based self-test for the SARS-CoV-2 virus and its variants. The CRISPR-based test is said to be cost-effective and meant for at-home use. Named miSHERLOCK, the diagnostic device offers results that are read and validated using a related smartphone app in one hour.

Qiagen has obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the use of its portable QIAreach SARS CoV-2 Antigen Test. QIAreach can identify SARS-CoV-2 antigens in two to 15 minutes in individuals with active infections. The test is capable of processing approximately 30 swab samples an hour and delivers digital results.