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Aptitude Receives US FDA Clearance for Next-Generation Metrix COVID Test

Shots:

  • The US FDA has granted 510(k) clearance to the next-generation Metrix COVID Test, with development supported by BARDA. The test is cleared for OTC and professional use in CLIA-waived settings
  • The handheld molecular test delivers approximately 3-fold higher analytical sensitivity & 30% faster results than EUA-authorized product, targeting urgent care & other decentralized settings
  • Aptitude is expanding the Metrix molecular diagnostics platform, with its COVID/Flu test under FDA review and additional products for RSV, Strep, and sexually transmitted infections in late-stage development or under FDA review

Ref: PRnewswire  |  Image: Aptitude  |  Press Release

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