FDA Approves Cheaper, Faster Saliva Test for COVID-19

On August 15, the FDA issued an emergency use authorization (EUA) to the Yale School of Public Health for its COVID-19 saliva test, SalivaDirect. While Yale’s saliva test is the fifth of its kind to be FDA-approved, the test is unique in requiring no swab or specialized collection device. 



FDA Commissioner Stephen Hahn called the test’s innovative techniques “groundbreaking” in their efficiency, highlighting the test’s potential to mitigate shortages in crucial test components, such as reagents. 

Unlike its predecessors, SalivaDirect requires no extraction of nucleic acids. Instead, the test uses enzymes to degrade the virus, exposing its genetic material for molecular detection. While extraction increases sensitivity, it’s a cumbersome, slow, and expensive process. 

According to Dr. Nathan Grubaugh of Yale University, the SalivaDirect method saves up to 2 hours of work and eliminates 75% of the costs. But that’s not all. 

Because the virus is stable in saliva for prolonged periods of time—and at high temperatures—expensive collection tubes and preservatives were found to be unnecessary. This discovery, alongside simplified testing techniques, whittles the cost of each sample to an estimated $10. The leading COVID-19 saliva test, developed at Rutgers University, currently costs consumers up to $150. 

According to Dr. Grubaugh, getting a handle on the pandemic—even before a vaccine—means the nationwide implementation of “cheap alternatives like SalivaDirect.” 

Yale’s saliva test is less complicated, less expensive, and less invasive than traditional testing methods. As yet another bonus, patients can view their results within hours—24 hours at most—rather than weeks. Moreover, saliva samples can be self-collected, lowering the risk of infection for healthcare professionals.