OMNIPATHOLOGY RECEIVES FDA EMERGENCY USE Authorization
PASADENA, Calif. (June 22, 2020) – OmniPathology today announced that it has received an FDA Emergency Use Authorization EUA letter for its Omni-COVID-19 Assay polymerase chain reaction (PCR) test. 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.
Omni-COVID-19 Test uses Real-Time (RT) PCR technology on the BD Max platform to detect SARS-CoV-2, the virus causing the COVID-19 pandemic. The test is performed on respiratory samples obtained by healthcare professionals.
“Receiving FDA Emergency Use Authorization is a major milestone for OmniPathology. Our assay passed a thorough and rigorous independent review by the FDA,” said Mohammad Kamal, MD, and CEO of OmniPathology.
As an independent, physician-owned and operated pathology lab, OmniPathology also can be more responsive in performing coronavirus testing. OmniPathology is committed to delivering test results within 24 hours, which should help reduce exposure to COVID-19 since infected patients are notified sooner and can take immediate steps to self-quarantine before they expose others.
“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,” said Dr. Kamal. “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. Since the release of our test in March 2020, we have been able to help patients in Pasadena and greater Los Angeles by providing test results within 24 hours.”
In addition to supplying Omni-COVID-19 assay tests to Los Angeles-area healthcare providers, OmniPathology is working with area businesses, including Hollywood studios, sports franchises, and others, to regularly test workers for coronavirus.
OmniPathology continues to work on increasing its testing capacity to ensure its ability to meet the growing demand for testing as businesses reopen, companies begin to test employees, and schools start to test students and faculty.
