SalivaDirect, Inc. (SDI) is 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.
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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 flexible nature of the SalivaDirect™ protocol reduces barriers to entry for labs by allowing them to use their existing reagent and instrument suppliers.
Cost-Efficient
Our test does not require swabs or preservative media in saliva collection devices, reducing the cost of the test kit itself. Utilizing a nucleic acid extraction-free approach reduces the cost of reagents and labor, as well as improves a 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 also been independently validated in 15+ countries around the globe. We anticipate a submission for De Novo authorization from the U.S. Food and Drug Administration in 2025.
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