Now that it has just received an EUA from the FDA for its SARS-CoV-2 pooled testing that can test 12 samples at once, Verily Life Sciences continues march into clinical laboratory service market during COVID-19 pandemic
As the COVID-19 pandemic has developed, one significant player to recently emerge in the field of SARS-CoV-2 testing has been Google sister company, Verily Life Sciences. Initially, Verily’s focus (see Introduces from COVID-19-STAT, published July 15) was on developing screening tools to identify individuals at risk for COVID-19. Verily later expanded its focus to include COVID-19 screening for employers and academic institutions, partnering with networks of laboratories to provide testing.
Verily’s role in the COVID-19 response has matured, with the company announcing the launch of its own Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory on Aug. 10, 2020. The development (see Notable from COVID-19 STAT, published Sept. 15) is seen as a shift away from the partnership-based approach that Verily had previously seemed to follow and now a move toward a more independent testing approach.
More recently, Verily was issued an emergency use authorization (EUA) Sept. 8, 2020, for a PCR-based SARS-CoV-2 diagnostic test. While the US Food and Drug Administration (FDA) has issued many EUAs for diagnostic tests, the Verily EUA includes authorization for pooled testing of up to 12 specimens at once. This represents the largest advancement in SARS-CoV-2 pooled testing technology to-date, with the largest pool previously receiving FDA authorization including only seven specimens per pool.
Verily Pooled Test Method, How It Works
According to the FDA EUA summary, the Verily SARS-CoV-2 test uses a matrix 2D-pooling strategy in which samples are pooled in a 96-well plate across the 12 rows and eight columns. Each sample is tested as part of the 8-plex pool and as part of the 12-plex pool, allowing either identification of individual positive samples or narrowing the positive samples down to a few candidate samples. Positive or candidates samples will then be retested individually.
“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,” Verily stated in a press release. “The need to scale will greatly benefit from innovative approaches that improve efficiency, such as pooling of samples. 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.”
Rapid Clinical Laboratory Ventures Bear Watching
As a subsidiary of Google’s parent company, Alphabet, Verily could become a significant player in the laboratory testing field. The resources that Verily has available may allow it to access the COVID-19 market much faster and to a much greater extent than most clinical laboratories could ever expect to achieve.
The new EUA provides Verily with the ability to perform SARS-CoV-2 pooled testing at much higher volumes than has previously been possible. This may increase the speed at which Verily is able to perform testing, allowing the company to offer a significantly higher number of tests than many other clinical laboratories.
Clinical laboratory leaders should be aware of the potential competition that Verily (and other clinical laboratory startups) may increasingly present. While this competition seems primarily confined to COVID-19 testing right now, this may signal broader entry into the clinical laboratory space by Alphabet, and it may indicate the potential of expanded clinical laboratory services by Verily in the future.
—By Caleb Williams, Editor, COVID-19 STAT