Oxford Immunotec Global PLC, a global, commercial-stage diagnostics company focused on developing and commercialising proprietary tests for the management of immune-regulated conditions, has exclusively licensed technology that measures antibody-secreting B cells from Bellvitge Biomedical Research Institute (IDIBELL), a biomedical research institute in Barcelona, Spain through its technology transfer office.
This technology is featured in a study published in Kidney International and broadens the company’s immunological measurement technology platform.
“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 commercialise the test, the technical feasibility and potential value of the assay have been demonstrated in 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 optimise 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.”
Human leucocyte antigens are 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 recognise self from non-self.
Panel of reactive antibody test is 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.
Donor specific antibody test is 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.