08 December 2016: Oxford, UK & Marlborough, USA - Oxford Immunotec Global PLC, a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for the management of underserved immune-regulated conditions, today announced that the New 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 for Babesia microti in 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, or babesia 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 the New England Journal of Medicine provide 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.”
Company: Oxford Immunotec Global PLC
Company Website: http://www.oxfordimmunotec.com/international/