By Turna Ray

Quest Diagnostics has launched a renal transplant rejection test that the company claims can help doctors figure out if their patients are rejecting their new kidneys "weeks before" clinical symptoms or other standard tests can detect such events.

Kidney transplant rejection is a costly and common occurrence. Quest believes that its blood-based, non-invasive Renal Transplant Monitoring test, if widely adopted, can save the healthcare system money by obviating the need for the more expensive tests currently in use.

Quest developed the laboratory test in collaboration with Beth Israel Deaconess Medical Center and Weill Cornell Medical College. The company claims that it is the first commercial molecular diagnostic for kidney transplant rejection.

The real-time PCR-based test gauges several RNA markers, including FoxP3, GZMB, and PRF1, which Quest exclusively licensed from Beth Israel and Weill.

Terry Strom, co-director of The Transplant Institute at Beth Israel, along with Manikkam Suthanthiran, chairman of the Department of Transplantation Medicine at Weill, have published data showing that biomarkers such as FoxP3 and others are useful in detecting acute cellular rejection of renal transplants.

Researchers from Weill Cornell and elsewhere have published studies in several peer-reviewed journals demonstrating an association between the RNA markers in Quest's panel and renal transplant rejection. Rises in blood RNA levels "often occur before a rise in blood levels of serum creatinine," Quest said in a statement. As such, the Renal Transplant Monitoring test may allow doctors to predict earlier that their patients are at risk of transplant rejection and take action to prevent this from happening.

Wendy Bost, director of media relations at Quest, told PGx Reporter that the company "validated the test in the performing laboratory prior to release."

In 2009, there were nearly 17,000 renal transplant procedures performed, making the kidney the most routinely transplanted organ. However, based on 2010 figures from the US Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients, 70 percent of kidney transplants from a deceased donor fail within five years.

Current standard procedures for assessing whether a patient is rejecting a kidney transplant involve checking serum creatinine levels to gauge renal function and performing biopsies of the kidney, which can result in bleeding, graft injury, or loss.

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Quest Launches MDx that May Predict Kidney Transplant Rejection Earlier than Current Methods