Pasadena Company Gets FDA Approval for 24-Hour Coronavirus Test

A Pasadena-based laboratory has received federal approval for the emergency use of its new “reliable and sensitive” COVID-19 test, capable of returning results in one day, the company announced this week.

OmniPathology has receive an Emergency Use Authorization letter from the U.S. Food and Drug Administration for its newly developed omni-COVID-19 assay polymerase chain reaction test, the pathological laboratory said Monday in a written statement. 

“OmniPathology is offering its reliable and sensitive new coronavirus test to Los Angeles area healthcare facilities and businesses with 24-hour turnaround on lab results to help minimize the spread of COVID-19,” according to the statement.

While testing has continued to become more accessible in L.A. County in recent months, with more than 960,000 tests administered, according to the Los Angeles County Public Health Department. But many receiving tests have complained that it took many days to get results.

“Receiving FDA Emergency Use Authorization is a major milestone for OmniPathology,” Founder and CEO Dr. Mohammad Kamal said. “Our assay passed a thorough and rigorous independent review by the FDA.”

“Our team is proud and honored to be part of the solution for the pandemic since we realize that accurate and reliable testing is the cornerstone of the fight against coronavirus,” he said. “The fast response by OmniPathology and its team is a testament to the company’s commitment to our role as a leading laboratory and its understanding of our responsibility in helping to find solutions to this national crisis.”