Aegis Sciences Corp. (Nashville, TN) performs some 20 million toxicology tests per year, making it one of the nation’s largest toxicology labs. On April
15, Aegis launched Covid-19 PCR testing with an initial capacity to perform up to 3,500 tests per day. Laboratory Economics recently spoke with Chief Executive Frank Basile, MD, to discuss Aegis and its Covid-19 testing strategy.

How many Covid-19 PCR tests is Aegis currently performing?
We are currently performing an average of about 10,000 tests per day with capacity of up to 30,000 tests per day. We’re using the PerkinElmer RNA/DNA extraction system and ThermoFisher’s QuantStudio 7 analyzer for testing.

Who are your Covid-19 clients?
We’ve added over 1,000 new clients over the past 12 weeks, including urgent care centers, surgery centers, nursing homes, doctor’s offices, correctional facilities and colleges and universities. We also have state contracts with Tennessee, Louisiana and Oklahoma. We placed a moratorium on new client starts in July in order to maintain a 24-hour turnaround time from specimen pickup to result reporting. This was recently lifted as we have increased capacity.

Are private payers matching Medicare’s reimbursement rate of $100 for Covid-19 PCR testing?

Yes, in the majority of cases. Medicaid, however, in some states is paying significantly below and/or are not credentialing because they insist on an “in-state bricks and mortar” presence which is slightly impractical during the pandemic. Additionally, certain payers are denying claims, paying the patient, or not responding at all. This is a significant problem and appears to be in direct conflict with the CARES Act.

Describe the NIH grant that Aegis was awarded and how it will be used.
Aegis has received a $6.6 million grant from the National Institutes of Health (NIH) under its Rapid Acceleration of Diagnostics (RADx) program. The grant funding will be used to expand our molecular lab from 3,000 square feet to 18,000 square feet. We’ll also be moving to Thermo Fisher’s highthroughput KingFisher Flex system for RNA/DNA extraction into the lab. We plan to increase our capacity to 60,000 Covid-19 PCR tests per day by September 30. In addition, we are developing a multiplexed Covid-19 + Flu A/B assay which will be available early October.

Any plans for pooled testing?
We have looked at it. However, we’re currently seeing positivity rates of around 10%, which makes pooled testing less feasible. Pooled testing is best suited for discrete population testing of groups expected to have positivity rates of <5%. Aegis serves clients nationwide that range from pre-surgery testing (low positivity rate) to walk-in clinics and correctional facilities (higher positivity rate). Our lab TAT averages less than 24 hours. Samples would have to be segregated to take advantage of pooled testing, leading to workflow complexity and potentially overall increases in TAT.

Has Aegis experienced any supply shortages?
Supplies haven’t been a limiting factor for us. We spent five weeks prior to launch getting our supply chain in order. For example, we diversified key supplies by validating specimen transport media from multiple vendors.
Rapidly finding and retaining good people has been the biggest challenge we have needed to overcome. Over the past 12 weeks we have hired over 200 employees, and will continue to hire more, especially for specimen accessioning and processing positions in the lab. Our current overall employee count is 1,051.

Describe your new Covid-19 antibody test.
On August 31, Aegis launched a Covid-19 antibody test that utilizes dried blood spot specimens. The test allows samples to be taken by fingerstick and should be popular for testing children and others. Samples are sent to our lab without the need for an invasive blood draw or additional processing at the collection site. We validated the test in accordance with FDA Emergency Use Authorization (EUA) requirements and it showed 99.9% specificity and 96.1% sensitivity. Demand for antibody testing has
been slow so far, but that is likely to change after a Covid-19 vaccine becomes available. Antibody testing could be used to determine if previous exposure to the virus occurred or to see if an individual that received a vaccine elicited an immune response. We expect this to become an important test later this year and into next year, especially as we bring additional product enhancements to market.

Have your toxicology test volumes bounced back from the lows?
Our toxicology volumes bottomed in mid-April but have since rebounded to approximately 80% to 85% of pre-pandemic levels. I expect we’ll be back to nearly 100% of “pre-pandemic” levels sometime by year’s end.

Do you think Covid-19 will come back in a severe way this fall/winter?
I expect cases to spike up, along with other respiratory infections, this coming fall and winter, although masking might limit the upsurge.