Pasadena, CA, USA – OmniPathology today announced the launch of its COVID-19 Lab Developed Test LDT. In response to the US Food and Drug Administration (FDA) policy announcement on February 29, 2020, seeking high complexity laboratories to start developing diagnostic tests for Coronavirus to address the COVID-19 outbreak. Recognizing the urgent need for a new COVID-19 test, OmniPathology reallocated all its research and development resources to develop the new test.
The Omni-COVID-19 Test will use Real-Time (RT) PCR technology and will be performed on the Becton Dickinson BD-Max system using its open access feature. 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 will be capable of potentially increasing its throughput to more than 550 tests per day during the following weeks. OmniPathology is planning to submit for FDA 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,” said Mohammad Kamal, MD Founder and CEO of OmniPathology. “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 is a physician-owned pathology laboratory located in Pasadena California. It specializes in Gastrointestinal pathology, GYN and male health and provides state-of-the-art molecular and cytogenetic testing to complement its pathology and immunohistochemistry testing with specific focus on screening and early detection of anal, cervical, colon and esophageal cancers. OmniPathology’s infectious menu includes HPV, other STD and gynecological, gastrointestinal and respiratory infectious panels.