SalivaDirect™ meets with 170 designated labs in 41 states in a weekly call to answer questions and offer individualized support. We moderate an online community to further assist labs in getting SalivaDirect™ testing up and running.
Our team is working to expand the impact of SalivaDirect™ testing domestically, with a focus on establishing low-cost and sustainable testing in vulnerable settings such as K-12 schools. In the future, we look to expand internationally to aid the global COVID-19 response.
SalivaDirect™has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.