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Oxford Immunotec Announces Exclusive Licensing Agreement With IDIBELL for B Cell Measurement, Technology Featured in Study Published in Kidney International
"We are excited to add the B cell assay to our portfolio of transplant diagnostic products in development," said Dr. Peter Wrighton-Smith, Chief Executive Officer of Oxford Immunotec. "While there is still significant development work to be done to commercialize the test, the technical feasibility and potential value of the assay have been demonstrated in today's published study."
The B cell measuring technology was developed by Dr. Oriol Bestard's research team at IDIBELL. Dr. Bestard, M.D., Ph.D. is head of the Transplant Nephrology team at Bellvitge University Hospital and an associate professor of medicine at the University of Barcelona. He also runs a research group at IDIBELL focused on immune-monitoring of anti-viral and allogenic adaptive immune responses using novel immune assays with the aim of trying to optimize the treatment of kidney transplant patients. The Kidney International study co-authored by Dr. Bestard showed the efficacy of the B cell technology in assessing sensitized kidney transplant recipients not identified by current serological immune tests and, therefore, at high risk of transplant rejection. The 70 patient study included patients on a waiting list for kidney transplantation as well as kidney transplant recipients undergoing antibody-mediated rejection.
The company plans to use the technology to develop and commercially launch one or more additional tests within its line of products for transplant medicine. Such tests would complement the currently available PRA Test (Panel of Reactive Antibodies) and the DSA Test (Donor Specific Antibody), which represent the standard of care for the assessment of the likelihood of an antibody-driven rejection event in transplant patients. The PRA and DSA tests depend on the identification of antibody levels to foreign HLA (Human Leucocyte Antigens) in the blood. Because these levels fluctuate or the antibodies disappear entirely for various reasons, patients at-risk for rejection are often missed.
The B cell assay developed by Dr. Bestard may overcome this problem by directly measuring the underlying B cells themselves, which have the potential to rapidly react to a donor organ and produce antibodies that contribute to acute rejection. By measuring these specific foreign HLA antibody-secreting B cells, the test is able to identify such sensitized patients regardless of the presence of circulating antibodies, potentially identifying at-risk patients missed by the PRA and DSA tests.
"This technology fills an unmet need in transplantation diagnostics and even though there is still a lot of work to be done, I am excited about the potential of this technology to bring important new information to transplant physicians," said Dr. Oriol Bestard, M.D., Ph.D. "I am delighted to be working to bring this assay to the market with Oxford Immunotec, a demonstrated leader in the development of tests that measure functional immune responses."
HLA - Human Leucocyte Antigens - Proteins on the surface of cells that are responsible for regulation of the immune system and particularly responsible for the ability of the immune system to recognize self from non-self.
PRA Test - Panel of Reactive Antibody test - An immunological laboratory blood test that assesses the extent to which the patient on the transplant waiting list will react, via pre-existing antibodies, to non-self. Any PRA score indicates that the patient has a higher risk of antibody mediated graft rejection.
DSA Test - Donor Specific Antibody test - An immunological laboratory blood test that assesses the presence of antibodies in the transplant patient that are generated specifically against the donor's HLA type. The presence of DSA indicates that the patient has a higher risk of antibody-mediated allograft rejection. Pre-transplant, the DSA test indicates which donor HLA types may not be tolerated or would carry a higher risk of antibody-mediated graft rejection. Post-transplant, persistence or appearance of DSA may indicate a high risk of ongoing or future antibody mediated graft rejection.
IDIBELL is a research centre that integrates the biomedical research of the Bellvitge University Hospital (HUB), the Catalan Institute of Oncology (ICO), and the University of Barcelona in the Bellvitge Campus (UB) and the the Viladecans Hospital (HV), located in south Barcelona, Spain. The main objective is to translate scientific discoveries into improved health by facilitating innovation and technological transfer actions, in order to improve the health and the quality of life of the population. The high quality of the research conducted in IDIBELL has been acknowledged by the Health Institute Carlos III, by awarding it the Health Research Institute accreditation in March 2009.
T-SPOT and the Oxford Immunotec logo are trademarks of Oxford Immunotec Ltd.
1Lúcia M et al. Preformed circulating HLA-specific memory B cells predict high risk of humoral rejection in kidney transplantation. Kidney International advance online publication, July 15, 2015; doi:10.1038/ki.2015.205
Oxford Immunotec Inc.
Oxford Immunotec Global PLC is a global, commercial-stage diagnostics company focused on developing and commercializing proprietary tests for the management of immune-regulated conditions. The Company's first product is the TSPOT®.TB test, which is used to test for tuberculosis infection. The T-SPOT.TB test 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 T-SPOT.CMV test is the Company's second product and the first in a series of products intended for the transplantation market. With this announcement, the Company now has seven additional active development programs, each of which leverages our T cell, innate immune, or this new B cell measuring technology. The Company is headquartered near Oxford, U.K. and in Marlborough, Mass. Additional information can be found at www.oxfordimmunotec.com.
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