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Sunday, July 19, 2020

FDA OKs emergency use of Quest COVID-19 test for pooled sample use

Quest Diagnostics (NYSE:DGX) has received emergency use authorization (EUA) from the FDA to use specimen pooling with its molecular diagnostic test for COVID-19.
In pooling, specimens must still be collected into individual vials, but then are combined into small batches or pools by the laboratory. The technique is an efficient way to evaluate patients in regions or populations with low rates of disease.
The company’s SARS-CoV-2 RNA test may be used with pooled upper respiratory specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swabs).
The company expects to deploy the technique at its laboratories in Chantilly, VA and Marlborough, Mass., by the end of next week with additional laboratories to follow.
The FDA also granted three EUAs for use of self-collection molecular diagnostic kit on the Hologic and Roche platforms, expanding use with healthcare provider supervision via telemedicine.


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