In a letter to the company dated yesterday, the FDA confirmed the EUA status for the qualitative test for detecting nucleic acid from SARS-CoV-2 in respiratory specimens procured through nasal, mid-turbinate, nasopharyngeal and oropharyngeal swabbing.
The test also can be used for the qualitative detection of nucleic acid from SARS-CoV-2 in pooled samples that contain up to 12 individual specimens collected by a healthcare provider using individual vials.
In a blog post, Verily said the continually growing demand for testing amid the return to schools and workplaces highlight the need for scaled testing efforts, which can be made more efficient by pooling samples.
According to the FDA letter, the test processing is limited to only Verily at its San Francisco headquarters, at which the company last month established a CLIA-certified lab to create additional lab capacity to support programs in the COVID-19 testing space as demand continues to increase while the pandemic goes on, including the company’s own return-to-work efforts.
Verily said at the time that it verified its lab with the TaqPath test kit from Thermo Fisher Scientific (NYSE:TMO), for which it requested EUA for the pooled sampling. In addition to the TaqPath kit, Verily verified the Roche Elecsys anti-SARS-CoV-2 antibody test and as of last month plans to implement more tests in its lab as well.