20/20 BioResponse Confirms Accuracy of Rapid Coronavirus Test Kits in Hospitals in Several U.S. States

April 3, 2020 22:55 UTC

Rapid Antibody Test Generates Results in under 10 minutes from Blood Drop without Laboratory Equipment

ROCKVILLE, Md.--(BUSINESS WIRE)-- 20/20 BioResponse, a business unit of 20/20 GeneSystems, Inc. announced today that it will begin shipping its CoronaCheck ™ COVID-19 Rapid Antibody Test Kit. The company’s action follows a study involving over 50 patients being treated or evaluated at five hospitals and medical practices in Washington D.C., Colorado, New Jersey, South Carolina, and Pennsylvania.

This study tested patients previously diagnosed as positive or negative for SARS-CoV-2 by the standard molecular diagnostic tests. Testing was performed at five separate sites throughout the United States and involved 50 patients. “The test results were found to be statistically consistent with the manufacturer’s stated performance characteristics and appear to meet the expectation of front-line physicians who participated in the study," said Michael S. Lebowitz, Ph.D. 20/20’s Chief Scientific Officer.

One of the evaluators, Dr. Charles H. Miranda, MD, from South Denver Internal Medicine, reported the product to be “highly reliable.” “I congratulate 20/20 BioResponse for being one of the first companies in the nation to understand the need and importance of providing clinicians with rapid point of care COVID-19 antibody testing,” said Miranda.

The test kits are rapid immunoassays (configured like a home pregnancy test) to detect IgM and IgG antibodies to SARS-CoV-2 in blood. SARS-CoV-2 is the coronavirus which is the cause of COVID-19 disease. Antibodies that bind to SARS-CoV-2 are detectable in most people between 7 and 10 days after the onset of symptoms. According to the March 16 FDA Guidance, antibody blood tests of this nature are “less complex” than the nucleic acid testing that the CDC and laboratories throughout the U.S. have been running since the start of this emergency. These tests give results in less than 15 minutes.

The subject test, made in China and approved by the Chinese FDA, was previously evaluated in using 188 clinical samples. The manufacturers reported a sensitivity of 87% and a specificity of 100%.

The need for these tests is well understood by experts in infectious disease. A recent editorial published by the American Society for Microbiology, including both the President and the CEO of that organization as two of eight authors, suggested that “antibody tests for SARS–CoV-2 may facilitate (i) contact tracing—RNA-based tests can help with this as well; (ii) serologic surveillance at the local, regional, state, and national levels; and (iii) identification of those who have already had the virus and thus may (if there is protective immunity) be immune.”

20/20 is now making this test available to U.S. based public health providers, hospitals, urgent care centers, and occupational health providers, especially those serving first responders. It also plans to request from FDA an Emergency Use Authorization to make these kits available to consumers through retail and internet purchase.

Please refer to www.CoronaCheckTest.com for product details, updates, and ordering information. (More than one product configuration may be offered; features and performance may vary slightly among configurations.)

About 20/20 GeneSystems

20/20 GeneSystems, Inc. (www.2020Gene.com) is a Rockville, MD based company focused on innovative diagnostics and detection products. In addition to the company’s blood tests that aid in the early cancer detection (www.OneTestforCancer.com), 20/20 has also commercialized its patented BioCheck® detection kit to help fire departments and other emergency response organizations screen suspicious powders. (www.BioCheckInfo.com).

Important Notice Regarding Regulation A Offering and Forward-Looking Statements

20/20 is offering securities under a qualified offering statement. You may obtain a copy of the offering circular that is part of that offering statement through this link. For more information about 20/20’s securities offering visit https://www.startengine.com/2020-gene-systems.

The information set forth in this Press Release may pertain to the Offering Statement referenced below. Both this Press Release and the Offering Statement include statements, estimates and projections with respect to our anticipated future performance and other forward-looking statements, which are subject to risks, uncertainties and assumptions. In some cases, you can identify these statements by forward-looking words such as “may”, “might”, “will”, “should”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “future” or “continue”, the negative of these terms and other comparable terminology. Such forward-looking statements are based on current plans, estimates and expectations and are made pursuant to the Private Securities Litigation Reform Act of 1995. These statements, estimates and projections are based upon various assumptions that we made concerning our anticipated results and industry trends, which may or may not occur. We are not making any representations as to the accuracy of these statements, estimates or projections. Our actual performance may be materially different from the statements, estimates or projections set forth below based upon a number of factors, including those contained in the Risk Factor section of the offering circular described below. We are under no duty to update any of these forward-looking statements to conform them to actual results or revised expectations.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200403005556/en/


Ron Baker
20/20 BioResponse
Phone: 301-785-5185

Lana Sansur
RMR & Associates
Phone: 301-978-1772


Source: 20/20 BioResponse

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