Represents third covered indication for Prospera
Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced that it has received confirmation that its Prospera Lung donor-derived cfDNA (dd-cfDNA) transplant assessment test has met coverage requirements from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX).
The MolDX technology assessment program has determined that Prospera Lung will be covered under the existing Medicare Local Coverage Determination for Molecular Testing for Solid Organ Allograft Rejection for use in the surveillance setting in lung transplant patients.
Lung transplantation has a five-year survival rate of 59%, the lowest rate of all transplanted organs. Moreover, in the last 20 years, there has been limited improvement in recipient survival.1 This is primarily driven by acute rejection (AR) and chronic lung allograft dysfunction (CLAD), which is the leading cause of mortality among lung transplant recipients.2
“The current standard of using transbronchial biopsy for monitoring lung transplant rejection is associated with significant procedural risks and complications and is a physical and emotional burden on the patient,” said Howard J. Huang, M.D., associate professor of clinical medicine, division of pulmonary, critical care, and sleep medicine at Houston Methodist Hospital. “Prospera Lung fulfills a critical unmet need for a less invasive method of detecting acute rejection to help guide biopsy decision-making and inform treatment.”
The Prospera Lung clinical validation, the VALID study,3 was published in 2022 and highlighted performance from 195 biopsy-matched samples from 103 patients. This blinded, prospective study analyzed Prospera Lung in connection with various complications from lung transplantation, including AR, CLAD and allograft infection. The study demonstrated outstanding performance, with an area under the curve of .91 when analyzing AR versus stable patients.
“Medicare’s decision enables broad access to the Prospera Lung test and represents a significant win for lung transplant patients and the field of transplant monitoring,” said Bernie Tobin, general manager of organ health at Natera. “Prior to this decision, nearly 50 percent of the top 50 transplant centers have used Prospera Lung. We are encouraged by this momentum and gratified by the ongoing support from members of the transplant community who understand the clinical utility of dd-cfDNA testing and the critical benefits it can bring to patients.”
About the Prospera test
The ProsperaTM test leverages Natera’s core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient’s blood. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy. The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. It has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
