CMS issues Medicare coverage to home-based kidney transplant rejection test by NephroSant
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The CMS Molecular Diagnostics Program has issued a local coverage determination for use of a needle-free urine test by NephroSant that detects allograft rejection after kidney transplantation, according to a company press release.
This decision, according to the release, will cover the cost of the test for eligible transplant recipients on Medicare.
“The favorable evaluation of our data by [CMS Molecular Diagnostics Program] MolDX and their ultimate coverage decision is a significant milestone for NephroSant and will enable us to get this powerful tool into the hands of providers,” Minnie Sarwal, MD, PhD, professor of surgery at University of California, San Francisco and founder of NephroSant, said in the release. “The early detection of transplant rejection is expected to be game changing for patients and represents an important step toward improving the health and longevity of transplanted kidneys.”
The test, known as QSant, provides a convenient method for assessing graft rejection, according to the release, as it is shipped directly to a patient’s home after being ordered by a treating physician. The patient then takes a single urine sample and ships it back to the NephroSant lab for analysis.
“We believe QSant has the potential to improve post-transplant patient care by giving nephrologists the information they need to act proactively months in advance of a rejection event,” Gina Ford, RPh, MBA, chief commercialization officer for the company, said in the release. “We look forward to introducing the only urine-based, [six]-biomarker kidney rejection test, as an at-home, noninvasive test for patients in the coming months.”
In March of 2021, Healio Nephrology reported on a contribution by DaVita to a Series A Funding Round which resulted in the company raising $16 million to fund the test. That story can be found here.
For specifics on the local cover determination, please visit: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38671.
Reference:
- NephroSant: Secures Medicare coverage for QSant, the first urine-based kidney transplant rejection test, and plans 2022 launch. https://www.biospace.com/article/releases/nephrosant-secures-medicare-coverage-for-qsant-the-first-urine-based-kidney-transplant-rejection-test-and-plans-2022-launch/. Published Sept. 22, 2021. Accessed Sept. 24, 2021.