Capturing the small pieces of DNA found circulating in the bloodstream has made headlines as the basis of liquid biopsy tests for cancer, but Natera aims to use the same technology for a diagnostic aimed at monitoring the progress of organ transplants.
The company has now launched its genetic Prospera test for lung transplant recipients, a new addition to its recently formed patient monitoring portfolio including kidney- and heart-focused versions. The blood test sifts for donor-derived, cell-free DNA from transplanted tissues, and analyzes the genetic material for signs of rejection.
This can provide a non-invasive surveillance alternative to bronchoscopic biopsy tests, according to Natera, by detecting organ injuries as well as difficult-to-spot infections.
The Prospera test’s commercial rollout comes shortly after clinical data for the diagnostic was touted earlier this month, as a late-breaking presentation during the annual meeting of the American College of Chest Physicians.
A prospective validation study conducted by The Ohio State University’s lung transplant program compared 204 blood tests with lung tissue biopsy samples, taken from 104 organ recipients. Thirty-five cases of acute organ rejection occurred, with the Prospera test demonstrating a negative predictive value of 97.33% to help rule out the condition.
“The Prospera test has been clinically validated as a tool for assessing both kidney and heart rejection in transplant patients, and we are thrilled to validate it for lung transplant assessment as well,” David Ross, Natera’s medical director for lung transplantation, said in a statement.
The lung test launch marks the third in as many months for the Prospera line, which debuted its heart transplant DNA assessment test in August and a kidney transplant offering in September.
Going forward, Natera plans to directly compare the Prospera lung diagnostic to the gold standard of transbronchial biopsy procedures, with a randomized, controlled non-inferiority trial plus an observational registry study to track chronic lung allograft dysfunction, the leading cause of mortality among organ recipients.