Natera Inc, San Carlos, Calif, a global leader in cell-free DNA testing, has announced the assignment of a unique Z-code for the company’s kidney transplant rejection assay, representing a key milestone toward the 2019 commercialization of its laboratory- developed test.
Steve Chapman, Natera.
“We are pleased with this progress along our reimbursement pathway,” notes Steve Chapman, Natera’s chief operating officer. “Obtaining this unique Z-code is an essential part of our CPT coding strategy, and it also puts us on similar footing with other companies in this space.”
Natera recently completed analytical and clinical validation of its donor-derived cell-free DNA assay, leveraging its proprietary massively-multiplexed polymerase chain reaction technology. In a blinded study, Natera’s assay successfully distinguished between active rejection and nonrejection, with high sensitivity and specificity. The company is in the process of submitting its dossier to be considered for a Medicare local coverage determination.
Paul Billings, MD, PhD, Natera.
“There is a significant unmet need for more accurate, noninvasive tools to monitor transplant rejection,” says Paul Billings, MD, PhD, Natera’s chief medical officer and senior vice president for medical affairs. “Natera’s assay may help physicians detect rejection events earlier, avoid unnecessary biopsies, and more safely optimize immunosuppression levels.”
There are more than 190,000 people living with a kidney transplant in the United Statesand roughly 20,000 new kidney transplant surgeries performed each year. 1,2
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