Mesa Biotech Receives 510(k) Clearance and CLIA Waiver for Its Accula™ Strep A Molecular Point of Care Test
Accula Strep A Test Further Expands Company's Commitment to Bring Routine Testing Closer to the Patient
Dec 09, 2020, 07:00 ET
SAN DIEGO, Dec. 9, 2020 /PRNewswire/ -- Mesa Biotech, developers of an affordable, easy to use, handheld testing platform for infectious disease diagnosis, today announced it has received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the US Food and Drug Administration (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 (POC).
Accula Strep A is the third molecular POC diagnostic on the Accula platform to receive FDA clearance and CLIA waiver, following the company's commercially available tests for Flu A/Flu B and RSV. In addition, the company received Emergency Use Authorization (EUA) for its SARS-CoV-2 cassette earlier this year. The ergonomically designed, simple to use Accula test, fits in the palm of your hand and is visually read, using reverse transcription-polymerase chain reaction (RT-PCR) technology to detect Strep A via throat, nasal or nasopharyngeal swab samples.
"With the addition of Strep A, we continue to deliver on our promise of bringing rapid, molecular diagnostics to the point of need," said Bruce Cary, Ph.D, Co-founder and Chief Scientific Officer, Mesa Biotech, Inc. "The current pandemic has accentuated the need for PCR testing at the point of care and we are excited to be spearheading developments in this area."
Group A streptococcus (GAS) is the most common bacterial cause of acute pharyngitis, an inflammation of the pharynx causing a sore throat and accounts for 15 to 30 percent of cases in children and 5 to 20 percent of cases in adults.1 It is estimated that 616 million people worldwide has a pharyngitis from a GAS infection annually and more than 18 million develop a severe GAS infection2. According to Pediatrics, GAS is easily and frequently spread among families, school-aged children and other close contacts via respiratory secretions, and infection peaks in the late winter and early spring.
"It is important to diagnose and treat Strep A infections promptly as it is contagious and secondary complications can develop, especially in children," said Hong Cai, Ph.D., Co-founder and Chief Technology Officer, Mesa Biotech, Inc. "Our Accula testing platform enables healthcare providers to reach a rapid diagnosis and administer the appropriate treatment, thus reducing the amount of time the patient is sick, preventing long-term health problems and helping prevent the spread of infection."
About Mesa Biotech Inc.
Mesa Biotech designs, develops, manufactures and commercializes next generation Rapid PCR tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech's Accula™ SARS-CoV-2 test was among the first POC tests to obtain Emergency Use Authorization. The company's Flu A/Flu B and RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA). For more information visit http://www.mesabiotech.com.
1 Bisno AL., and al., Clin Infect Dis. 2002; 35 (2): 113-125
2 Carapetis JR., and al Lancet Infect Dis. 2005;5(11):685–94
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SOURCE Mesa Biotech Inc.
