Natera Inc. recently announced the assignment of a unique Z code for the company’s kidney transplant rejection assay in preparation for the commercialization of its upcoming 2019 Clinical Laboratory Improvement Amendments-certified lab developed test.
“We are pleased with this progress along our reimbursement pathway,” Steve Chapman, chief operating officer of Natera, said in a company press release. “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.”
The company recently completed analytical and clinical validation of its donor-derived cell-free DNA assay, which successfully distinguished between active rejection and non-rejection with high sensitivity and specificity.
Natera is in the process of submitting its Medicare dossier for local coverage determination consideration.
“There is a significant unmet need for more accurate, non-invasive tools to monitor transplant rejection,” Paul Billings, MD, PhD, chief medical officer and senior vice president of medical affairs for Natera, said in the release. “Natera’s assay may help physicians detect rejection events earlier, avoid unnecessary biopsies and more safely optimize immunosuppression levels.”