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Broad Institute

The reissued EUA expands the types of samples that may be used with the Broad Institute's PCR-based SARS-CoV-2 test, which was first authorized in July.

The Assurance Testing Alliance will handle the logistics and operations required to connect labs with groups in need of regular SARS-CoV-2 testing.

The diagnostics are capable of detecting fewer than two parasites per microliter of blood and would cost an estimated $.61 per test.

Some of the firms will receive money to speed up test development, while others will use the funds to expand their testing and manufacturing capacity.

A number of diagnostic labs have considered saliva-based SARS-CoV-2 testing but decided against it, while other groups continue to pursue it.

UCSF's test, developed with Mammoth Biosciences, uses CRISPR technology, while the tests from the Broad Institute and BioSewoom are PCR-based.

Assays like SwabSeq, Dx-Seq, and LAMP-Seq promise to analyze tens to hundreds of thousands of samples in parallel but might be constrained by sample availability.

The platform can detect a single virus in more than 1,000 samples at a time or more than 160 viruses, including SARS-CoV-2, in a small number of samples.

News items for the in vitro diagnostics industry for the week of March 23, 2020. 

The method, dubbed GoPhAST-R, was codeveloped by researcher from the Broad Institute and NanoString, which now hopes to work with a partner to commercialize it.

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