Oxford Immunotec Announces New England Journal of Medicine Publication on Clinical Trial Results of Serological and Nucleic Acid Tests for Babesia in Blood Screening
OXFORD, United Kingdom and MARLBOROUGH, Mass., 2016-12-08 13:00 CET (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for the management of underserved immune-regulated conditions, today announced that theNew England Journal of Medicine(“NEJM”) has published an article on a three-year clinical trial completed by Oxford Immunotec’s Imugen division, and the American Red Cross (“ARC”) to evaluate a serology and Nucleic acid Amplification Test (“NAT”) testing regime for Babesia in blood screening. The review article “Screening forBabesia microtiin the US blood supply” is authored by Susan Stramer of the American Red Cross, and will appear in the December 8, 2016 print issue.
Babesia, orbabesia microti,is a parasitic protozoan transmitted by ticks and is particularly prevalent in the Northeastern part of the US. It infects red blood cells and can cause a disease called Babesiosis. In addition to becoming infected via a tick bite, patients can get Babesia through blood transfusions from Babesia-infected donors. Babesia is a significant and growing cause of transfusion-associated infections; however, no Babesia test is yet approved by the FDA for blood screening. Imugen has developed both a serology test and a NAT for Babesia for use in blood screening.
The clinical trial, completed under an FDA Investigational New Drug (“IND”) application, screened approximately 90,000 blood samples to evaluate the effectiveness of Imugen’s serology and NAT testing regime in detecting Babesia-infected donors. No reported cases of transfusion-transmitted Babesiosis were associated with the 75,331 screened donations from high risk states as compared to 14 cases per 253,031 unscreened donations. The clinical trial determined that Imugen’s testing regime is effective in detecting Babesia in blood samples.
“The data in the publication in theNew England Journal of Medicineprovide compelling evidence on the efficacy of the Babesia screening regime that Imugen has developed in conjunction with the ARC,” said Peter Wrighton-Smith, Ph.D., Chief Executive Officer of Oxford Immunotec. “We look forward to progressing these Babesia assays through the FDA approval process and ultimately to commercialization for blood screening.”
Oxford Immunotec Global PLC is a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for the management of underserved immune-regulated conditions. The Company’s first product is the T-SPOT®.TBtest, which is used to test for tuberculosis infection. The T-SPOT.TBtest has been approved for sale in over 50 countries, including the United States, where it has received pre-market approval from the Food and Drug Administration, Europe, where it has obtained a CE mark, as well as Japan and China. The company’s second product line is a range of assays for tick-borne diseases, such as Lyme disease, obtained through the acquisitions of Imugen and Immunetics. The T-SPOT.CMVtest and the T-SPOT.PRTtest are part of the Company’s third product line focused on the transplantation market. In addition to these three product lines, the Company has additional active development programs in other immune-regulated conditions. The Company is headquartered near Oxford, U.K. and in Marlborough, Mass. Additional information can be found atwww.oxfordimmunotec.com.
T-SPOT, the Imugen logo and the Oxford Immunotec logo are trademarks of Oxford Immunotec Ltd. Immunetics is a trademark of Immunetics, Inc.
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