Monday, August 10, 2020

Verily stands up CLIA-certified lab focused on COVID-19 testing

Verily stands up CLIA-certified lab focused on COVID-19 testing

Surging COVID-19 testing demand is once again outpacing lab capacity, and nationwide, people are waiting a week or sometimes longer to get test results. In response to the continued demand for testing, Verily has established a CLIA-certified lab at our South San Francisco headquarters to create additional lab capacity in support of programs in the COVID-19 testing space, including our own return-to-work efforts for our own employees.

Deb Hanks

Deb Hanks, MD, Verily’s head of Pathology

What are the challenges we’re seeing right now with testing?

Diagnostic labs are experiencing unprecedented demand for their services, sometimes resulting in longer turnaround times from sampling to return of results. Highly experienced labs, adept at handling high volumes of testing, have gone from a two-to-three day turnaround time for a molecular-based RT-PCR COVID-19 test to seven days or longer. When test results are delayed, not only do everyday decisions become harder for the person tested - for example, whether it's safe to return to work - but it becomes challenging for our public health departments to trace local outbreaks, interrupt transmission, and formulate guidance for their communities.

How is the testing backlog impacting therapeutic development efforts?

The time it takes to return test results can be a rate-limiting factor for the development of new treatment interventions. For example, trials for new potential therapies may require only a few days from initial collection of a COVID-19 test sample to a patient joining an interventional trial. Reducing the testing turnaround time can help support research needed to bring new therapies and treatments to market by identifying infected individuals quickly enough for them to join these studies.

How are participants in Verily’s programs today getting COVID-19 testing?

We have established partnerships with several leading test providers for our COVID-19 testing programs and plan to continue scaling with existing lab partners, as well as with the Verily lab, to meet our customers' and community partners' needs for testing across the country.

What is the status of Verily’s efforts to establish a CLIA-certified lab on the Verily campus?

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. 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. 

In addition, we have submitted an EUA application for an adaptation of the TaqPath test for use in testing pooled patient specimens. 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.

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. Patient privacy is also important to us, and our systems and practices are intended to safeguard the privacy of patient information.

How will Verily use the lab?

We’ve established this lab to provide a focused specialty service with rapid turnaround time. We are launching with the capacity to run several thousand tests per day, primarily focused on our Healthy at Work customers.

Deb Hanks, MD, is lead pathologist at Verily, and was previously founder and CEO of Premier Pathology Laboratories, Inc. and the chief pathologist for Agilent Technologies.