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Re: DewDiligence post# 234408

Tuesday, 09/01/2020 4:05:44 PM

Tuesday, September 01, 2020 4:05:44 PM

Post# of 257275
Roche’s will launch 15-min COVID-19 test in EU in late September—will seek FDA EUA:

https://www.roche.com/media/releases/med-cor-2020-09-01b.htm

The SARS-CoV-2 Rapid Antigen Test is for use in point of care settings for both symptomatic and asymptomatic people… The test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centers.

At launch, there will be 40 million SARS-CoV-2 Rapid Tests available, per month. This capacity will increase more than two-fold at the end of this year to help with testing demands of healthcare systems globally.

Similar to ABT’s BinaxNOW test (#msg-157908540), Roche’s rapid COVID-19 test uses lateral flow (rather than PCR) and detects SARS-CoV-2 protein (rather than RNA).

Roche has not yet disclosed the price per test.

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