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APhA Foundation, NOWDiagnostics launch nationwide in-pharmacy real-time COVID-19 antibody testing

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PRINGDALE, Ark. – The American Pharmacists Association Foundation (APhA Foundation) and NOWDiagnostics, Inc., a Springdale-based leader in innovative diagnostics testing, today announced that NOWDiagnostics’ ADEXUSDx COVID-19 antibody test, a rapid-results self-contained fingerstick test, that can be used at point of care, that accurately detects the presence of COVID-19 antibodies in 15 minutes, will now be made available to IMPACT Care Transformation Network (IMPACT Network) pharmacies nationwide.

In 2021, the APhA Foundation, a supporting Foundation of the American Pharmacists Association – the leading association of pharmacists in the United States, launched the IMPACT Care Transformation Network—empowering partnering pharmacy practices to collaborate on scaling innovative care models through infrastructure and opportunities that enable pharmacists to deliver and be compensated for innovative services. IMPACT Network pharmacies can now begin offering the ADEXUSDx® COVID-19 antibody test to interested patients, who will obtain results via APhA Foundation’s RxTest.Solutionsthat enable secure consumer and healthcare provider access to results through an innovative technology platform (see https://IMPACT.CareTransformation.Network for more information).

“The APhA Foundation is pleased to offer the ADEXUSDx COVID-19 antibody test through our IMPACT Network pharmacies across the country in conjunction with RxTest.Solutions, and we know that pharmacists will use the test to continue to provide exceptional patient care. Becoming aware of their antibody status resulting from a vaccination or actual disease, provides another valuable piece of data that could help patients to make informed decisions, along with guidance from their health care provider, as to the best course of action in their health care journey. As has been demonstrated since the pandemic began, pharmacist-provided care is essential to the public health and wellbeing of communities everywhere, and we believe this opportunity with NOWDiagnostics and the APhA Foundation presents another excellent way for pharmacists to serve their patients and communities,” said Benjamin M. Bluml, RPh, Senior Vice President, Research and Innovation, American Pharmacists Association Foundation.

The ADEXUSDx COVID-19 antibody test detects antibodies that bind to the receptor binding domain (RBD) subunit of the S1 spike protein of the SARS-CoV-2 virus. The most protective antibodies develop against this portion of the spike protein S1 domain and are induced by vaccination. Other antibody tests, designed to detect nucleocapsid antibodies, will not detect antibodies elicited by the vaccine, only those elicited through natural infection. While the Food and Drug Administration (FDA) has not released guidance yet for companies to conduct the trials necessary to make the claim of determining antibody response due to vaccination and therefore have not authorized any antibody tests for this specific indication, research studies underway have identified individuals who test positive for antibodies to COVID-19 with the ADEXUSDx COVID-19 antibody test, and who did not report prior COVID-19 disease but did receive a COVID-19 vaccine.

Kevin Clark, CEO of NOWDiagnostics, said, “It is a privilege to partner with the APhA Foundation to offer an important COVID-19 test solution to our nation’s pharmacists, one of the most trusted groups of healthcare professionals. We are grateful for the important work that pharmacists have been performing on the front lines, providing vaccines to prevent the spread of COVID-19. We are pleased to provide them with another important tool to ensure the health and safety of their patients.”

Since the onset of the COVID-19 pandemic, reliable antibody testing has played a pivotal role in the identification of convalescent plasma donors to provide life-saving therapy for those most affected by COVID-19. In addition to this role, antibody testing offers important utility to understand immunity following infection, and potentially therapy and vaccination—for individuals, healthcare providers, businesses, community, and governments. However, it is not known at this time if the presence of antibodies against SARS-CoV-2 as determined by this and other tests confers immunity to infection.

In May 2021, NOWDiagnostics announced receipt of Emergency Use Authorization from the Food and Drug Administration (FDA) for the ADEXUSDx COVID-19 Test’s use in moderate complex settings and at the point of care. In August 2020, this project was funded in whole or part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract No. 75A50120C00156 to NOWDiagnostics for the development of the ADEXUSDx COVID-19 Test. Trials for over-the-counter use are ongoing.


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