We are advancing the use of saliva-based testing as a readily-deployable, sensitive, patient-friendly option that increases access to affordable and equitable infectious disease testing.
SalivaDirect, Inc. is thrilled to announce that our annual conference for 2025 will be held virtually! Mark your calendars for June 3-6 to hear from top experts in diagnostics on a GLOBAL scale.
Check out Frontiers’ latest perspective article on the SalivaDirect Model! Focused on scalable solutions for global health, this highlights the challenges faced during the COVID-19 pandemic and how innovative testing methods can improve our response to future health crises.
The countdown to #GivingTuesday has begun! Your contribution to our “Shape the Future of Diagnostics” campaign will help fund initiatives like our mobile lab, improving testing access in underserved communities.
The SalivaDirect test is a cutting-edge, non-invasive COVID-19 diagnostic test that detects SARS-CoV-2 RNA from saliva samples.
Saliva collection is non-invasive, reducing patient aversion to testing. It is readily self-collected, which can reduce the risk of viral transmission to healthcare workers.
The reagent-flexible and instrument-flexible nature of the SalivaDirect protocol allows for labs to use their existing suppliers, reducing the barrier to entry for labs.
Our test does not require swabs or preservative media in saliva collection devices, reducing the cost of the test kit itself. Additionally, utilizing a nucleic acid extraction-free approach reduces the cost of reagents, labor, and improves your laboratory’s turnaround time.
The SalivaDirect protocol for SARS-CoV-2 has been authorized for Emergency Use by the U.S. Food and Drug Administration, ensuring it meets the agency’s rigorous performance standards for in vitro diagnostics. It has additionally been independently validated in 15+ countries across the globe. We anticipate a submission for De Novo authorization from the U.S. Food and Drug Administration in 2025.
Important Regulatory Information about SalivaDirect™
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.
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