The Corgenix ReEBOV Ebola rapid test was the first RDT and the first immunoassay authorized for emergency use by the FDA for the presumptive detection of Ebola virus. In February 2015, it was also listed as eligible for procurement by the World Health Organization in the fight against the West Africa Ebola outbreak. Corgenix' patented AtherOx technology was recently incorporated into the Health Diagnostic Laboratory Inc. (HDL Inc.) Oxidized LDL (oxLDL-β2GPI) heart disease risk test.
"We're proud of the groundbreaking research that our Corgenix team is presenting at AACC this year," said Werner Hofacher, CEO, ORGENTEC. "This work reflects our combined commitment to improving science, serving the patient and positively impacting global health care."
The combined ORGENTEC-Corgenix specialty diagnostics company exhibiting in Clinical Lab Expo booth #3711 boasts a portfolio of more than 350 diagnostic tests, including ELISA, IFA, LFI, IT and immunoblot. ORGENTEC completed its acquisition of Corgenix Medical Corporation in March 2015 and is exhibiting for the first time at AACC. ORGENTEC-Corgenix representatives will be available throughout the expo to discuss capabilities and answer questions about the new company.
The following restrictions apply to the Corgenix ReEBOV Ebola rapid test:
This test has not been FDA cleared or approved;
This test has been authorized by FDA under an Emergency Use Authorization for use by laboratories and facilities adequately equipped, trained and capable of testing for Ebola infection (including treatment centers and public health clinics);
This test has been authorized only for the detection of Ebola viruses (including Ebola Zaire virus detected in the West Africa outbreak in 2014);
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About ORGENTEC Headquartered in Mainz, Germany, with U.S. operations in Broomfield, Colorado, ORGENTEC offers one of the industry's most comprehensive portfolios in autoimmune diagnostics and cardiovascular diagnostics with additional strengths in infectious disease, inflammatory rheumatic diseases, thrombotic disorders and organ function testing. The company's products are supported by a global distribution network, and its line of automated instruments for diagnostics and serology enables labs to complete multiple assays and deliver faster results than traditional analyzers. Additionally, ORGENTEC contract develops and manufactures products for key medical and life science companies.
To learn more about this exciting new development in specialty diagnostics, visit us at booth #3711. For more information on ORGENTEC, visit www.ORGENTEC.com or call +49 6131 / 9258-0; for more information on Corgenix, visit www.corgenix.com or call 303.457.4345 ext. 351.