Friday, October 15, 2021

Medicare Coverage for Nephrosant "QSant" - First Urine-based Kidney Transplant Rejection Test

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:
    • MolDx LCD DL38671 here.
    • MolDx article for the above, billing instructions, Article A58170, here.
  • 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.