A respiratory test from San Diego-based Mesa Biotech recently received U.S. Food and Drug Administration clearance and a key waiver.
Mesa Biotech’s Accula RSV test diagnoses respiratory syncytial virus, a major cause of lung and respiratory infections.
The test is the second diagnostic on Mesa Biotech's Accula platform to receive FDA 510(k) clearance and a Clinical Laboratory Improvement Amendment waiver, which allows home use. The company’s Flu A/Flu B test received the same designations earlier this year.
"The addition of Accula RSV test to our Flu A/Flu B test significantly enhances our upper respiratory rapid, molecular diagnostic offerings," Hong Cai, co-founder and CEO, said in a news release. "It is important to have a distinct in-office diagnosis for RSV and flu, especially in young children and the elderly to provide timely, accurate information to clinicians to ensure appropriate treatment and improved patient management."
The company’s palm-sized Accula test system requires a nasal swab, less invasive than a nasopharyngeal swab, a method of collecting a sample from the back of the nose and throat.
Privately held Mesa Biotech has secured $23 million in investment this year, first through a $3 million series A round and then a $20 million series B round.