FDA Grants EUAs for Wren Labs, P23 Coronavirus Tests, Binx Health At-Home Sample Collection Kit

26 October 2020

genomeweb

NEW YORK — The US Food and Drug Administration on Tuesday reissued Emergency Use Authorizations for SARS-CoV-2 tests developed by Wren Laboratories and P23 Labs to allow their use with new specimen types, and granted EUA to Binx Health's SARS-CoV-2 at-home nasal swab collection kit.

Wren's COVID-19 PCR Test is designed to detect the SARS-CoV-2 N gene using primers and probes developed for the US Centers for Disease Control and Prevention's CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel. In August, the test received FDA EUA for use with nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage specimens. 

Under the reissued EUA, Wren's test is also authorized for use with saliva specimens self-collected at home or in a healthcare setting using the Branford, Connecticut-based company's saliva collection kit.

P23's TaqPath SARS-CoV-2 Assay is designed to detect the virus' N, S, and ORF1ab genes. In May, the test received EUA for use with oropharyngeal, nasopharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasopharyngeal wash, nasal aspirate specimens, and bronchoalveolar lavage samples. It was also authorized for use with saliva samples collected using OraSure Technologies' Omnigene Oral OM-505 saliva collection device. 

Under the reissued EUA, Little Rock, Arkansas-based P23's test may also be used with Binx's At-Home Nasal Swab COVID-19 Sample Collection Kit. The collection kit, which now has EUA, includes a swab, transport tube, and materials for mailing the specimen to a lab for processing.

In July, Boston-based Binx partnered with Sherlock Biosciences to develop a CRISRP-based SARS-CoV-2 test.

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