Notable Among CLIA-Certified COVID-19 Testing Laboratory Upstarts

From simple screening tools to fully functioning clinical laboratory operations, quick-turn COVID-19 testing center labs may begin developing partnerships with employers to grab share of local lab business

As the COVID-19 pandemic continues to strain testing capacities of clinical laboratories across the country, the increased demand also creates an environment conducive to new clinical laboratory ventures.

One of the most notable among them is Verily Life Sciences which recently announced that it will launch a CLIA-certified laboratory focused exclusively on COVID-19 testing. Verily’s entry into the COVID-19 clinical testing market is particularly significant because it is backed by one of the largest companies in the world. Verily is controlled by Alphabet, the parent company of Google.

As the COVID-19 STAT Intelligence Briefings Service reported in June, Verily’s initial focus was on the development of screening tools that could be used to help identify individuals at risk for COVID-19. Verily expanded its focus to include screening specifically for employers and academic institutions, partnering with networks of laboratories to provide testing.

The recent announcement by Verily that it has established its own CLIA-certified clinical laboratory performing COVID-19 diagnostic testing prioritizes a perhaps significant development in Verily’s offerings which continue to expand.

Rapid CLIA Lab Venture Targets COVID-19 Testing for Employers

Debra Hanks, MD, announced the launch of Verily’s clinical laboratory in a blog post dated Aug. 10, 2020. Hanks is lead pathologist at Verily and is founder and former CEO of Premier Pathology Laboratories, Inc. Hanks also previously served as chief pathologist for Agilent Technologies.

*Verily’s lead pathologist Debra Hanks, MD*

… launching with the capacity to run several thousand tests per day, primarily focused on Healthy at Work customers, said Deb Hanks, MD (above), of Verily Life Sciences about the upstart of a CLIA-certified clinical laboratory for COVID-19 testing. (Photo source: Verily)

“When the pandemic hit, it became clear that we needed to rapidly establish a lab and to receive California state licensure and CLIA certification, which we have done,” Hanks explained. “We’ve verified the performance in our lab of the SARS-CoV-2 RT-PCR test via ThermoFisher Scientific’s TaqPath test kit. This test kit has received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). This test is intended to tell you whether you’re currently infected with COVID-19.”

While single-specimen PCR testing will be the initial method of diagnostic testing used by Verily’s lab, Verily has already announced an intention to pursue pooled testing methods as soon as possible. “We have submitted an EUA application for an adaptation of the TaqPath test for use in testing pooled patient specimens,” Hanks’ blogged interview states. “Pooling is expected to enable our clinical lab to increase our testing capacity even further, while maintaining a high level of overall test performance. We have also verified the Roche Elecsys Anti-SARS-CoV-2 antibody test, and we plan to implement additional tests in our lab.”

New Clinical Laboratory Infrastructure Includes LIMS

In addition to setting up a clinical lab, Verily reports that it has developed its own laboratory information management system (LIMS). “The lab infrastructure is now up and running, and we have created a lab information system that will enable us to implement a strict chain of custody procedure for the specimens in our care,” Hanks announced. “Patient privacy is also important to us, and our systems and practices are intended to safeguard the privacy of patient information.”

Even though Verily’s clinical laboratory has just reached the point of being able to test specimens, it already has ambitious goals. “We’ve established this lab to provide a focused specialty service with rapid turnaround time,” Hanks said. “We are launching with the capacity to run several thousand tests per day, primarily focused on our Healthy at Work customers.”

While Verily will initially be focused on providing testing as a complement to its existing screening tool, the infrastructure and resources at the company’s disposal may allow this to quickly become a significant competitor with clinical laboratories around the country. It may not be the only competitor. A significant and growing number of organizations are building new lab facilities specifically to provide COVID-19 tests.

Clinical laboratory leaders should be aware of this new potential source of competition and ensure that their existing partnerships for employer and academic testing are strong. If the COVID-19 pandemic continues into 2021, then clinical laboratories can expect many new competitors for SARS-CoV-2 testing.