It was Dr. Stanley Rose’s own kidney transplant that sparked the idea for Transplant Genomics, a company that’s finding a better way to test early on for organ graft rejection.
“As an organ transplant recipient, myself, I know that once you wake up from surgery from day one you’re wondering, ‘How am I doing?’” Rose said. “But the reality is that the tests out there that can tell you how you’re doing are pretty poor.”
Boston-area Transplant Genomics just licensed well-validated technology from Northwestern University and The Scripps Research Institute that identifies biomarkers associated with organ rejection. It plans to commercialize its first test, which gauges the likelihood of organ rejection in a kidney transplant, early next year. The blood test will indicate whether treatment or a biopsy for further diagnosis is necessary for a patient.
Transplant Genomics plans to launch with this kidney transplant performance test, but will soon expand into diagnosing the prognosis of other organ grafts including those of the liver, pancreas, lungs and more. The business model is to offer these proprietary tests through the company’s own CLIA-certified lab.
Current follow-up testing methods for organ are woefully outdated – it’s been 30 years since the latest innovation in that field, Rose said. A patient is already experiencing some form of organ rejection by the time they’re symptomatic. Stats vary, but roughly half of kidney recipients experience some sort of progressive graft dysfunction in the year following the transplant.
This makes the addressable market quite large, Rose said – the company’s market estimate for a diagnostic test is $300 million in the U.S., and $1 billion worldwide.
This is because about 17,000 kidney transplants take place each year in the U.S. About 172,500 patients with end-stage renal disease were living with a transplanted kidney in 2009, according to the National Institutes of Health, and require constant testing to gauge how functional their new organs are.
But the danger of acute organ rejection is “nearly impossible to diagnose” currently because doing biopsy after biopsy just isn’t feasible, said Dan Salomon, founding director and chief scientific advisor of TGI and a professor at Scripps.
A recent study in the American Journal of Transplantation involving seven transplant centers used a peripheral blood gene expression profiling test to classify kidney graft recipients into three categories of graft status – acute rejection, acute dysfunction but no rejection, and stable graft performance. The predictive accuracy of the test was very high, the study found, and was able to whittle down patients into buckets of those who needed further treatment and those who likely didn’t.
“A minimally invasive blood test could be used to predict clinical rejection, to diagnose subclinical rejection, and to monitor treatment to assure clinicians that the therapy was fully effective,” he said.