20/20 GeneSystems, Inc. issued the following announcement on May 18.
20/20 GeneSystems, Inc. announced that it will offer in its CLIA laboratory a COVID-19 antibody test that received an Emergency Use Authorization (EUA) from the FDA on May 3. According to test manufacturer Roche Diagnostics, the blood test has a specificity greater than 99.8% and sensitivity of 100% (14‑days post-PCR confirmation) and is used to determine if a person has developed antibodies to SARS-CoV-2, the virus that causes COVID-19.
The company will also seek to collect anonymized clinical and epidemiological data from those taking this test and use it to train machine learning algorithms to help predict the extent to which individual antibody levels may reduce the risk and severity of re-infection as social distancing practices become more relaxed.
“Based upon several years of our work with tumor marker blood tests powered by AI, we are most optimistic that machine learning will similarly improve the predictive value of antibody tests to SARS-CoV-2," said Michael S. Lebowitz, Ph.D. 20/20’s Chief Scientific Officer.
Since late March, 20/20 has been importing and distributing in the U.S. rapid COVID-19 antibody tests and will continue to work with the manufacturers of those tests to help them obtain EUAs for their use at the point of care in accord with the latest Guidance from the FDA. “As use for these antibody tests is expected to grow exponentially over the coming months some medical providers will seek the convenience and speed of rapid, fingerstick testing while others will opt for laboratory tests using traditional blood collection that provide higher levels of sensitivity, specificity, and reliability,” said Jonathan Cohen, 20/20’s CEO. “We are proud to be among the first companies to offer both forms of testing.”
Those who obtain the company’s blood test for early cancer detection (www.OneTestforCancer.com), will have the option of having their anti-SARS-CoV-2 antibody levels checked from the same collected blood specimen without additional charges. Consumers, employers, and assisted living facilities can obtain these tests through referral by their physicians.
Please refer to www.CoronaCheckTests.com for product details, updates, and ordering information.
About 20/20 GeneSystems:
20/20 GeneSystems, Incis a Rockville, MD based company focused on innovative diagnostics and detection products. In addition to the company’s blood tests for early cancer detection 20/20 has also commercialized its patented BioCheck® detection kit to help fire departments and other emergency response organizations screen suspicious powders.
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