The MolDx program has granted coverage to the NephroSant "QSant" urine-based test, a multi biomarker test including urine donor organ DNA. Previous Medicare coverage in this space was attained by the CareDx and Natera tests, which use a blood test to look at donor organ DNA shed into the circulation. Leaking of donor DNA signals damage to the transplanted organ.
- See Nephrosant's website here.
- See a Genomeweb article (subscription) about the clinical launch earlier in 2021, here.
- See the company's press release here.
- For publications, see a 601-patient study, Yang et al., in Science Translational Medicine 2020, here.
- See also a validation study in 223 samples from multiple sites, Nolan et al., J Clin Med 2020, here.
- Nolan et al. conclude, "The Q-Score [also] detected subclinical rejection in patients without an elevated serum creatinine level but identified by a protocol biopsy. This study confirms that QSant is an accurate and quantitative measurement suitable for routine monitoring of renal allograft status."
- See the MolDx LCD and articles as follows:
- Palmetto also runs a website that lists coverage ("yes/no") by lab and test name, here.
- At that website:
- The test is listed as Covered, and priced at $2753.
- This is essentially the same as the CareDx AlloSure test, and the Natera Prospera test, which are $2840.
