[11/16/20 – 360dx] Precision medicine firm Tempus said on Monday that it has partnered with the Yale School of Public Health to refine a saliva-based test for SARS-CoV-2.
The test, called SalivaDirect, uses dualplex RT-qPCR to detect SARS-CoV-2 RNA in saliva samples without the need for special types of swabs or collection devices, and does not require a separate nucleic acid extraction step. It was developed at Yale and received Emergency Use Authorization from the US Food and Drug Administration in August.
Under the terms of the deal, Tempus and Yale will further develop the test to enable at-home sample collection and to enable combination testing for SARS-CoV-2 and influenza. The partners noted that new iterations of the test will require FDA review.
Additional terms were not disclosed.
“Expanded at-home testing is critical to help control the pandemic and reduce future waves of COVID-19 infection,” Tempus CSO Joel Dudley said in a statement.
In October, Chicago-based Tempus received FDA EUA for a PCR-based SARS-CoV-2 test it developed with Alimetrix. The firm also recently began an effort to structure and aggregate real-world clinical and genomic data from up to 50,000 COVID-positive patients with academic partners to better understand the disease and how it affects different people.