Co-Diagnostics, Inc. Provides Update on "ABC" Test for Influenza A, Influenza B, and COVID-19
September 24 2020 - 06:30AM PR Newswire (US)
SALT LAKE CITY, Sept. 24, 2020 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced today that its Logix Smart™ ABC Test (Influenza A/Influenza B/COVID-19) is anticipated to be ready for launch to US CLIA laboratory customers the first week of October 2020.
"Co-Diagnostics is committed to participating in the fight against COVID-19 through the development and manufacture of vital diagnostic testing solutions, with none perhaps as important as this upcoming ABC multiplex test," remarked Dwight Egan, CEO of Co-Diagnostics. "Our patented CoPrimer™ technology platform is ideally suited for multiplex reactions by substantially reducing 'primer-dimers,' a phenomenon in PCR molecular tests that results in false positive results. At a time when the need for accurate detection of COVID-19 as well as the differentiation between strains of the flu has never been greater, we are pleased to be able to contribute to the safety and well-being of communities across the country and around the world."
The test will initially be made available to CLIA labs who will be using it in their own laboratory developed tests, or LDTs, while the Company proceeds with the FDA Emergency Use Authorization submission and CE marking registration.
About Co-Diagnostics, Inc.: Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a state-of-the-art diagnostics technology. The Company's technology is utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.
$ABMC to Distribute Co-Diagnostics Inc. EUA Issued Logix Smart(TM) Covid-19 Test
KINDERHOOK, NY / ACCESSWIRE / October 7, 2020 / American Bio Medica Corporation (OTC PINK:ABMC) today announced they have signed a distribution agreement with Co-Diagnostics, Inc. (CODX) granting ABMC the right to market and sell the Logix Smart Covid-19 tests in the United States on a non-exclusive basis.
The test operates using a single step RT-PCR process in lower respiratory tract fluid samples such as bronchoalveolar lavage, sputum, tracheal aspirate, and upper respiratory tract fluid samples, such as nasopharyngeal and oropharyngeal swabs, obtained from patients who present with signs and symptoms for Covid-19, with easy-to-interpret results in under two hours.
ABMC will market the Covid-19 diagnostic test only to clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA), and in accordance with the Emergency Use Authorization issued to Co-Diagnostics, Inc. by the U.S. Food and Drug Administration on April 3, 2020.