Capacity for 3,500 tests a day begins April 15; results available within 24 hours
Aegis Sciences Corporation, a leading healthcare company that provides clinically innovative medication compliance testing and consulting services to providers, will serve as a regional reference laboratory for COVID-19 testing being directed by Federal, State, and Local COVID-19 Response Task Forces, or ordered by physicians and other authorized healthcare providers in the State of Tennessee. The test detects the presence of the underlying virus that causes COVID-19 and is for use with patients who meet current guidance for evaluation of infection with COVID-19.
Aegis will launch COVID-19 testing on April 15 and be ready to accept samples and perform up to 3,500 COVID-19 tests per day with a 24-hour turnaround time. Aegis’s reimbursement for its test will be set to match the Medicare established floor rate of $51.31. “We are delighted to respond in a timely manner to the COVID-19 crisis and support the community with a test that meets Aegis’s industry-leading quality standards, while establishing reimbursement at the minimum rate. It was critically important to do both. Our dedicated team of laboratory scientists has worked diligently to leverage Aegis’s extensive capabilities and moved quickly to offer this valuable diagnostic tool to aid in the fight against COVID-19,” said Dr. Frank Basile, CEO of Aegis Sciences Corporation.
The BioPharma laboratory at Aegis Sciences Corporation, located at 501 Great Circle Road, has validated and launched a molecular test for SARS-CoV-2, the virus that causes COVID19, with a 24-hour turnaround time. This assay is performed by Real Time Reverse-Transcriptase Polymerase Chain Reaction (Real Time RT-PCR) and can detect as little as 20 copies of virus in a milliliter (ml) of sample. Samples are to be collected in accordance with the Centers for Disease Control and Prevention (CDC) and New York State-issued guidelines, with a nasopharyngeal swab as the preferred collection device. The testing is performed in a highly automated manner to ensure accuracy, precision, and reproducibility. “Aegis’s COVID-19 test offering has been developed and validated in accordance with FDA requirements and will provide an extremely sensitive and specific result in a timely manner to enable the Department of Health (DOH), physicians, and patients to make the best decisions possible.” said Dr. Matthew Hardison, SVP Lab Operations Aegis Sciences Corporation.
Aegis will report testing results to the Tennessee Department of Health and to the CDC in accordance with applicable public health emergency response requirements. Aegis is accredited for all testing it performs under its College of American Pathologists (CAP) accreditation #8853197.
In addition, Aegis will offer IgM and IgG antibody testing in early May of 2020. “We believe this is a critical piece in building an understanding of how much of the U.S. population has developed immunity to the virus. This may be a marker for infection history and help efforts to mitigate a potential fall resurgence,” said Dr. Frank Basile, CEO of Aegis Sciences Corporation.