Pasadena Lab Upends Daily Activities to Focus on Developing COVID-19 Test

A physician-owned Pasadena medical corporation has dropped its research programs to focus instead on developing diagnostic tests for coronavirus.

A statement by OmniPathology last week said the company, recognizing the urgent need for a new COVID-19 test, “reallocated all its research and development resources” to develop the new test.

OmniPathology, a Pasadena-based physician-owned professional medical corporation that specializes in providing academic level pathology services, has launched their new Laboratory Developed Test (LDT) for COVID-19 in response to the US Food and Drug Administration’s policy announcement in February seeking the development of diagnostic tests for coronavirus.

The LDT, which the company calls Omni-COVID-19 Test, will use real-time PCR technology and will be performed on the Becton Dickinson BD-Max system using its open access feature.

PCR, or polymerase chain reaction, is a laboratory technique used to make multiple copies of a segment of DNA, especially from very small or mixed samples, and in the process offers increased precision, more reliable measurements and absolute quantification.

OmniPathology said the test will be performed on swabs collected by physicians, nurses and other licensed healthcare professionals. The test will take two hours and the initial capacity will be 110 tests per day. As national needs continue, OmniPathology said they will be increasing their throughput to more than 550 tests per day during the following weeks.

The statement said OmniPathology plans to submit the LDT to the Food and Drug Administration for emergency use authorization (EUA) within the next two weeks.

“This fast response by OmniPathology and its team is a testament to the company’s commitment to its role as a leading laboratory and its understanding of its responsibility in finding solutions to this national crisis,” Dr. Mohammad Kamal, OmniPathology Founder and CEO, said. “This test will be available to our local community in Pasadena and Los Angeles with results available on the same day and up to 24 hours. We are working with local health authorities to ensure tests are offered to those who are most in need according to the most recent guidelines.”

OmniPathology, whose offices and laboratory are located at 11 W. Del Mar Blvd. Suite 203 in Pasadena, specializes in gastrointestinal pathology, gynecology and male health and provides state-of-the-art molecular and cytogenetic testing with specific focus on screening and early detection of anal, cervical, colon and esophageal cancers.

For more information, visit www.omnipathology.com.