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OraSure Secures $13.6M BARDA Funding For InteliSwab COVID-19 Test 510(k) Clearance and CLIA Waiver

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  • The Biomedical Advanced Research Development Authority (BARDA) will provide up to .6 million in funding to OraSure Technologies Inc (NASDAQ: OSUR).

  • 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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