FDA ranks Quadrant Covid-19 saliva test as most sensitive on market!

Published on Dec 9, 2020
More exciting news to share!
The recently updated FDA SARS-CoV-2 Reference Panel ranked the Clarifi COVID-19 Test Kit from Upstate Medical and Quadrant Biosciences as the most sensitive saliva test currently on the market!
Why is this important?
Tests with higher Limits of Detection (LoD) could miss more infected patients resulting in more false negatives. A recent study has suggested that every 10-fold increase in LoD is expected to increase the false negative rate of a test by 13% (1). Unfortunately, LoD’s for tests currently on the market vary significantly with some as high as 180,000 NDU/mL.
The Clarifi COVID-19 Test Kit had a Limit of Detection (LoD)of 600 NDU/mL, making it not only the most sensitive saliva test, but among the most sensitive of all COVID tests. (FDA Reference Panel)
NYS Governor Andrew Cuomo Thanks Quadrant Biosciences
Also, NYS Governor Andrew Cuomo officially recognized the efforts of Quadrant Biosciences and Upstate Medical in developing this test:
"New York's medical experts are second to none and from the very beginning of this pandemic, we have relied on their vast knowledge and expertise to inform our response...On behalf of the family of New York, I thank SUNY Upstate Medical, Quadrant Biosciences and Dr. Frank Middleton for their diligence and steadfast commitment to fighting this invisible enemy."
-- Governor Andrew Cuomo
Read more here!
As always, we appreciate the support of each and every one of our investors! If you have not yet invested, please consider joining us on this journey!
-----
¹ Arnaout, R. et al. (2020) SARS-CoV2 Testing: The Limit of Detection Matters. BioRxIV (preprint)
===============================================
This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the detection of nucleic acid from SARSCoV-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 diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The emergency use of your product as described in this letter of authorization must comply with the conditions and all other terms of this authorization. V. Duration of Authorization This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act
