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The fund is related to obtain 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for OraSure's InteliSwab COVID-19 rapid test from the FDA.
Related Content: OraSure Secures 5M Contract For OTC COVID-19 Tests.
InteliSwab is a simple test that uses an integrated swab to self-collect a sample from the lower nostrils.
The result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone, or laboratory analysis needed.
It has three FDA Emergency Use Authorizations for professional point-of-care use, prescription home use, and OTC use.
With FDA 510(k) clearance, InteliSwab can continue to be marketed without a public health emergency declaration.
Following 510(k) clearance, the Company will pursue a CLIA waiver for InteliSwab, ensuring the test can continue to be performed by an untrained user outside the laboratory setting.
Price Action: OSUR stock is up 0.18% at $11.21 during the market session on the last check Thursday.
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