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Hematogenix
Hematogenix® announces the offering of COVID-19 antibody testing from blood samples using the Elecsys® Anti-SARS-CoV-2 test developed by Roche (SIX: RO, ROG; OTCQX: RHHBY). The offering of this test, which the U.S. Food & Drug Administration (FDA) has approved with emergency use authorization1, reaffirms Hematogenix’s commitment to the community during these unprecedented times.
COVID-19 is an infectious viral disease that affects humans with varying degrees of symptoms and severity. Once infected, patients produce the short-term IgM antibodies as the initial fight against the virus. Afterwards, patients produce IgG antibodies within 1-3 weeks after infection, which remain in the blood for an unknown period of time after the infection has passed. While it is currently unknown whether the presence of antibodies indicates future immunity to the virus that causes the COVID-19 infection, the identification of these antibodies in individuals will assist in identifying those who may have been previously exposed to this particular virus.
“We are committed to assisting our community gather more information about COVID-19, and particularly to helping the frontline and essential workers determine who has developed antibodies and who may have been exposed to the virus that causes COVID-19,” said Dr. Hytham Al-Masri, Medical Director of Hematogenix®. Dr. Al-Masri added, “I am particularly pleased that our community and patients will have access to COVID-19 antibody testing during these times, and grateful to our team of scientists for making that possible.”
The Elecsys® Anti-SARS-CoV-2 test has specificity greater than 99.8% and 100% sensitivity, 14 days after confirmation of infection by molecular methods2. This test has also demonstrated no cross-reactivity with other types of coronaviruses, such as those that cause the common cold, thereby reducing the chance of producing false positive results. The goal is that this test will provide insights to researchers and physicians to better understand how well individuals may build immunity to the virus after infection - it is currently not an indication of immunity. Hematogenix® will be able to run hundreds of samples daily, addressing the immediate needs of the community and partners they serve.
About Hematogenix®
Hematogenix® is a specialized CRO with a global presence, focused on cancer research and diagnostics. The company employs a team of top scientists and board-certified clinical, anatomic, and hematopathologists from around the world. Hematogenix® offers an array of biomarker development and testing services which navigate the complexities of human subject clinical trials. The company's clinical laboratories are CAP and CLIA certified, GCP-compliant, and serve both the pharmaceutical industry as a specialized clinical research organization and the oncology industry as a clinical and anatomical testing provider. Learn more about Hematogenix's comprehensive biomarker development and testing services at www.hematogenix.com.
Hematogenix® is a registered trademark of Hematogenix® Laboratory Services, LLC.
ELECSYS® is a registered trademark of Roche Diagnostics GmbH.
https://www.fda.gov/media/137602/download
This test has not been FDA cleared or approved – this test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories;
This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Elecsys® Anti-SARS-CoV-2. Package Insert 2020-04, V1.0; Material Numbers 09203095190 and 09203079190