Wednesday, September 9, 2020

Verily receives Emergency Use Authorization (EUA) for pooled testing and publishes COVID-19 guidance

Verily receives Emergency Use Authorization (EUA) for pooled testing and publishes COVID-19 guidance

At Verily, we are leveraging our expertise in user engagement, scalable testing sites, high throughput laboratory workflows, and data analytics to better understand COVID-19 and help improve community health outcomes. From the start of the health crisis, Verily responded to the urgent need for scalable community testing and has developed and made available a return to school and work platform. Each of these programs was informed by Verily's team of clinical and laboratory scientists who have been integrating the most recent information from biomedical literature and verifying findings in our own labs. In addition, as we have seen that the need for more testing continues unabated, we have invested in the development of pooling methods that we expect to improve access to testing even further. Here, we share information and context on our COVID-19 testing processes for the review and potential benefit of researchers, commercial partners and health authorities as we collectively work to respond to the pandemic.

We have published a series of white papers that touch on a variety of topics related to the identification of COVID-19 infection, including explanations of Verily's high sensitivity and pooled COVID-19 testing approaches, both of which received Emergency Use Authorization (EUA) from the FDA this week.

  • Innovation in pooled testing: The demand for testing continues to grow and is increasingly important as employers and schools gradually return their populations to shared spaces. The need to scale will greatly benefit from innovative approaches that improve efficiency, such as pooling of samples. Pooling refers to the process of combining multiple samples into a single test, which results in conservation of reagents.  When the expected rate of positive detection is low (i.e. the likelihood that an individual in the pool is infected is less than 10%), the pooling method requires ¼ to ½ the number of tests as standard PCR tests. Verily's investigations have determined that pooling is an effective model for testing that can efficiently scale with increasing demand without compromising performance. Read more

  • Sample collection methodologies: In the interest of public health, Verily scientists have continuously reviewed the evidence supporting different types of sample collection options being used for COVID-19 testing. In April, we endorsed the use of mid-turbinate swabs in addition to nasopharyngeal swabs (read more), and our most recent position is that additional sample collection methods have ample evidence supporting their use in accordance with FDA authorizations and CDC guidance. Read more

  • Laboratory testing methodologies: Verily scientists have closely monitored the innovation and deployment of COVID-19 testing methodologies, including molecular, antigen, and antibody tests. When choosing a testing approach, key criteria to consider include the goal of the test, accessibility of sample collection kits, ease of collection, end-to-end test turnaround time, performance, scalability using automation, and test reagent availability. Read more



What's next?

We recently announced that our CLIA certified lab in South San Francisco is fully operational and is generating COVID-19 test results. The lab is being used by customers of Verily's Healthy at Work program, including Waymo and other customers near Verily's South San Francisco campus, and will continue to be an integral part of our COVID-19 initiatives.

Collection of Verily's COVID-19 white papers for download:

  1. Developing a more efficient, scalable COVID-19 diagnostic testing approach. (Verily COVID-19 Testing Team, Sept 2020) 
  2. Emerging evidence supports patient-collected mid-turbinate nasal swabs as a practical alternative to nasopharyngeal swabs for COVID-19 testing. (Verily COVID-19 Testing Team, April 2020) 
  3. Multiple sample collection methods are available for COVID-19 testing. Here are some of the pros and cons of each option. (Verily COVID-19 Testing Team, Sept 2020)
  4. Multiple molecular methods are available for COVID-19 testing. Here are some of the pros and cons of each. (Verily COVID-19 Testing Team, Sept 2020)