NORCROSS, Ga., May 2, 2016 – Immucor, Inc., a global leader in transfusion and transplantation diagnostics, announced today the launch of its kidney Solid Organ Response Test, kSORT: a molecular gene expression assay that measures a kidney recipient’s immune response to predict organ rejection and graft injury. kSORT will be available exclusively through Immucor DX, the company’s CLIA certified and CAP accredited independent clinical laboratory as a Laboratory Developed Test (LDT).
The kSORT assay is a cutting-edge advancement in transplant medicine and represents the first post-transplant surveillance assay for kidney transplant recipients to be made available globally. With a simple blood draw, kSORT calculates a patient’s immune risk by using qPCR to measure RNA gene expression levels and, together with the company’s proprietary algorithm, produces a personalized risk index at the time of testing.
“We have quantified the performance of kSORT, including accuracy, precision, sensitivity, and specificity, which were well within acceptable parameters,” stated Tiffany Roberts, PhD, Laboratory Director at Immucor DX. “The assay performance includes sensitivity and specificity of 100% and 96%, respectively, after excluding an indeterminate rate of 11%.”
Combining kSORT patient surveillance testing with the current standard of care provides clinicians with a novel diagnostic tool that indicates graft inflammation and/or early kidney injury in a personalized manner.
“There is a significant unmet need for a non-invasive assay for prospective assessment of the immune risk threshold that drives rejection injury in an organ transplant. Such an assay needs to be independent of an invasive biopsy of the organ, should be able to predict the advent of inflammation in the organ well before it advances into the transplant, and should trigger an actionable response from the clinician. The kSORT multigene test fills this unmet need. It detects an activation signal from monocytes in the peripheral blood, the same cells that traffic into the organ to drive rejection injury, well before established tissue damage,” stated Minnie M. Sarwal M.D., Ph.D., FRCP, DCH Professor of Surgery, Division of Transplant Surgery University of California, San Francisco (UCSF), and inventor of kSORT.
The commercialization of kSORT is an important milestone in Immucor’s investment in post-transplant surveillance diagnostics. kSORT complements Immucor’s C3d product, which measures the binding and cleaving of the complement protein C3, as well as Immucor’s DSA product, which detects donor-specific antibodies in transplant recipient’s blood. Together, these products enable clinicians to better identify a kidney transplant recipient’s dynamic immune risks. These products further complement Immucor’s commitment to the transplant diagnostics market, with HLA typing available in both SSO and NGS technologies, and a full line of antibody products.
For questions or to order kSORT, please contact the Immucor Dx Reference Laboratory at 1.800.363.5915 or via the website at www.immucor.com/dx.
kSORT (the kidney Solid Organ Response Test) is a molecular gene expression assay that measures a kidney recipient’s immune response to predict organ rejection and graft injury. Originally developed by Minnie Sarwal, PhD, MD, a world-renowned transplant nephrologist, kSORT uses a proprietary algorithm and qPCR to measure RNA gene expression and produce a personalized risk index. kSORT is available exclusively through Immucor DX, Immucor’s CLIA certified and CAP accredited independent clinical laboratory as a Laboratory Developed Test (LDT). To order kSORT, please call Immucor DX at 1.800.363.5915 or visit our website at www.immucor.com/dx .
Founded in 1982, Immucor is a global leader in transfusion and transplantation diagnostics that facilitate patient-donor compatibility. Our mission is to ensure that patients in need of blood, organs or stem cells get the right match that is safe, accessible and affordable. With the right match, we can transform a life together. For more information on Immucor, please visit our website at www.immucor.com.