Simplifying Testing, Amplifying Access
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.
Save the date
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.
Scalable Solutions for Global Health: The SalivaDirect Model
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.
Shape the Future of Diagnostics
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News & Updates
July 12, 2024
Mobile Lab Helps Yale Pathology Establish Relationships, Build Trust With Community
January 27, 2022
New partnership between CT, Yale to expand saliva-based COVID testing at 2 New Haven locations
April 24, 2023
High-Tech Mobile Lab-in-a-Van Will Bring Needed Testing to Underserved Communities
August 15, 2020
Saliva-Based COVID-19 Test Developed by Yale Scientists Authorized for Emergency Use by FDA
The SalivaDirect test is a cutting-edge, non-invasive COVID-19 diagnostic test that detects SARS-CoV-2 RNA from saliva samples.
The SalivaDirect test for COVID-19 is:
Non-Invasive and Self-collectible
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.
Flexible and Scalable
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.
Cost-efficient
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.
Authorized for Emergency Use by the FDA
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.
Our Funding Partners
