Mesa Biotech has received 510(k) clearance and CLIA waiver from FDA for its Accula Strep A test. The Strep A cassette, for the molecular detection of Group A Streptococcus bacterial nucleic acid by rapid PCR, is cleared for diagnosing both children and adults, and provides laboratory quality results in 30 minutes at the point of care. As the third molecular POC diagnostic on the Accula platform to receive FDA clearance and CLIA waiver, the ergonomically designed, simple to use test fits in the palm of the hand. It is visually read, using reverse transcription-polymerase chain reaction (RT-PCR) technology to detect Strep A via throat, nasal, or nasopharyngeal swab samples.

Mesa Biotech