ViveBio, LLC, a privately held biotechnology company focused on providing high quality yet cost-effective solutions for specimen transportation, storage and blood component separation, along with cutting edge clinical diagnostics, has signed a worldwide exclusive licensing agreement with Renovar, Inc. for urine based biomarkers to predict and monitor kidney diseases as well as rejection in transplant recipients.  

Based upon unique inflammatory protein signatures found in the urine of diseased or injured kidney's, the Renovar technology can be used to assess the health of a patients kidney's, guide therapeutic decision making and help stratify patients by risk for developing acute rejection.

"This is an important step for ViveBio as the company evolves from a purely preanalytical player into a clinical diagnostics business," said Timothy Murray, ViveBio president.  "This technology enables monitoring of kidney transplant patients for the earliest indication of rejection and will give clinicians a new tool in post transplant patient management." Current medical practice assesses the health of the implanted kidney by monitoring and measuring non-specific signals within the body (i.e. serum creatinine) and unfortunately, these signals can only be measured after the process of rejection has started and kidney damage has occurred.

Based upon an NIH sponsored, prospective, multicenter study of 280 kidney transplant recipients researchers evaluated the urinary levels of nine messenger RNAs and two proteins which are known to be associated with kidney transplant rejection.  They identified Monokine induced by interferon-gamma (MIG) messenger RNA (mRNA) and MIG protein as the clinically significant biomarkers.  After further testing, the researchers found that MIG protein was better at ruling out rejection than any of the mRNA's tested.  It was also capable of identifying patients likely to have stable long-term kidney function and identify those patients who were unlikely to experience rejection or loss of kidney function over the next 18 months.  The investigators noted that urinary MIG protein levels began to increase up to 30 days before clinical signs of kidney injury.

In an NIH issued press release, NIAID director Dr. Anthony S. Fauci, M.D. said, "A noninvasive urine test to accurately monitor the risk of kidney rejection could dramatically reduce the need for biopsies and possibly enable doctors to safely reduce immunosuppressive therapy in some patients. . ." Dr. Fauci went on to say, "The results of this study support the further development of noninvasive tests for the detection and management of transplant rejection."

"It's exciting to see this technology moving forward which can potentially help kidney transplant patients avoid problems and enjoy longer function from their new kidney," said Dr. Stuart Knechtle, M.D., F.A.C.S.  Executive Director, Duke University Transplant Center.

"We plan to make a urine based MIG protein assay available in 2016 either through a CLIA laboratory or one of the platforms we are evaluating," said Murray.  "ViveBio is preparing for additional clinical studies as well as exploring collaborations with pharmaceutical companies to employ the MIG protein test and other biomarkers as companion diagnostics in the transplant and kidney disease areas."

Renovar, founded in 1999 by an internationally-recognized University of Wisconsin-Madison transplant surgeon, is an early-stage biotechnology company pioneering the development of diagnostic tests for kidney disease and transplant monitoring.