ABMC to Distribute Co-Diagnostics Inc. EUA Issued Logix Smart(TM) Covid-19 Test
American Bio Medica Corporation (OTC PINK:ABMC) has signed a distribution agreement with Co-Diagnostics, Inc. (CODX) to market the Logix Smart Covid-19 tests in the U.S. This non-exclusive agreement allows ABMC to offer a diagnostic tool that provides results in under two hours. The tests are aimed at clinical laboratories certified under CLIA and follow FDA guidelines. CEO Melissa A. Waterhouse highlighted the importance of this addition to their current Covid-19 testing solutions, which also include antibody tests.
- Signed a distribution agreement with Co-Diagnostics for Covid-19 tests.
- Non-exclusive rights to market the Logix Smart Covid-19 tests.
- Tests provide rapid results in under two hours, enhancing diagnostic capabilities.
- Expansion of product line complements existing Covid-19 antibody tests.
- Dependence on regulatory approvals for continued market access.
- Potential risks associated with increased competition in the testing market.
- History of recurring net losses raises concerns about financial stability.
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.
Chief Executive Officer Melissa A. Waterhouse stated, "We are excited to offer our customers another testing solution for Covid-19. The Co-Diagnostic RT-PCR test enables us to offer customers a diagnostic tool that can be run on high-throughput machines. We can get a lot of necessary information from antibody testing over time and we believe there are a number of additional applications for antibody testing, but the need for diagnostic testing is still great in the US. The Co-Diagnostic RT-PCR test is a great complement to the Rapid IgG/IgM antibody test we already distribute."
For more information on ABMC or its products, please visit www.abmc.com.
About American Bio Medica Corporation
American Bio Medica Corporation manufactures and markets accurate, cost-effective immunoassay test kits, primarily point of collection tests for drugs of abuse, and distributes a rapid test to detect Covid-19 antibodies and a RT-PCR test to detect Covid-19. The Company also currently manufactures (on a contract basis) tests to detect respiratory syncytial virus (RSV) and malaria and, with the ability to manufacture tests for many other medical conditions, viruses and diseases in its FDA registered and ISO certified facilities.
This release may contain forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ, and such differences could be material. Such risks and uncertainties include, but are not limited to, risks and uncertainties related to the following: continued acceptance of our products, increased levels of competition in our industry, acceptance of new products, future sales and profit levels of the rapid antibody test and RT-PCR test for Covid-19 that we are distributing, product development, compliance with regulatory requirements, including but not limited to our ability to obtain marketing clearance on our product for our intended markets, intellectual property rights, our dependence on key personnel, third party sales and suppliers, trading in our common shares may be subject to "penny stock" rules, our history of recurring net losses and our ability to continue as a going concern. There can be no assurance that the Company will be successful in addressing such risks and uncertainties and the Company assumes no duty to update any forward-looking statements based upon actual results. Investors are strongly encouraged to review the section entitled "Risk Factors" in the Company's annual report on Form 10-K for the year ended December 31, 2019, quarterly reports on Form 10-Q, and other periodic reports on file with the Securities and Exchange Commission for a discussion of risks and uncertainties that could affect operating results and the market price of the Company's common shares.
Contacts:
Melissa A. Waterhouse
Chief Executive Officer
(800) 227-1243, Ext 107
SOURCE: American Bio Medica Corporation
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FAQ
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