New Data Boosts Value Proposition of AlloSure

The first donor-derived cell-free DNA test to assess allograft health in kidney transplant patients is also beneficial for repeat transplant recipients, a new study finds.

When our kidneys fail to function as they should, our treatment options generally begin with dialysis and end with a kidney transplant. Unfortunately, transplanted kidneys last, on average, between 12 years and 15 years (depending on if the donor is living or deceased, and if they are a relative or not). Some recipients are lucky if they even get five good years out of their transplanted kidney.

CareDx has already established the clinical value of AlloSure, a donor-derived cell-free DNA test designed to assess allograft health in kidney transplant patients, and new data demonstrates the test's clinical utility in patients who require repeat kidney transplants. The findings, published in the American Journal of Transplantation in December, could go a long way toward filling an unmet need in the space by helping doctors closely monitor and optimize care for this particular population.

"The relevance of this paper is we've demonstrated for the first time how [the test] actually performs in these patients who have a second or even third or fourth transplant," CareDx Chief Medical Officer Jim Yee told MD+DI.

Yee explained that most of the time when a patient receives a new kidney, their failed kidney is left in the body. He said 15% of transplant patients have more than one transplanted kidney in their body.

Brisbane, CA-based CareDx initiated the study to find out how its AlloSure test performs for those patients. AlloSure measures the level of donor-derived cell-free DNA (dd-cfDNA) in the recipient's blood. When an injury to the transplanted kidney occurs, dd-cfDNA is released into the bloodstream, so an increase in dd-cfDNA can be a sign of rejection.

The study found that in patients without evidence of rejection, the median readouts of AlloSure were significantly lower than threshold levels for rejection in both single kidney transplant recipients and repeat kidney transplant recipients, CareDx said. In patients with active rejection, AlloSure levels were also similarly elevated in both patient groups.

"We found that our test can be used very similarly in people with repeat transplants compared to those with a single transplant," CareDx CEO Peter Maag told MD+DI.

Maag said one thing that holds a lot of small diagnostic companies back is not knowing how to navigate the reimbursement side of things, but the AlloSure test is fully covered by Medicare, he noted.

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