Wednesday, August 23, 2023

First Approval of a Whole Genome Test in Medicare: From MolDx to Wash U; $3228

Update, coverage at Genomeweb September 19 here.


MolDx has issued the first-ever approval of a whole-genome test in cancer, the Chromoseq WGS test from Wash U for blood cancers.


Medicare patients now have coverage for ChromoSeq, a novel test for two blood cancers developed by the Washington University School of Medicine in St. Louis. This is the first whole-genome sequencing test for cancer to receive reimbursement authorization from the CMS - specifically, from the MolDx program, which provides genomic policy for 28 states, including Missouri.

The coverage is for patients with acute myeloid leukemia or myelodysplastic syndrome; Medicare and Medicare Advantage patients nationwide have access to the test if it is provided via Wash U.  The DEX portal (operated by MolDx) shows a price of $3228 for the test. 

The press release remarks,

“This approval reflects the power and clinical validity of ChromoSeq to assess the full range of genetic mutations responsible for some of the most deadly blood cancers, which can help guide treatment decisions for individual patients,” said Richard Cote, MD, the Edward Mallinckrodt Professor and head of the Department of Pathology & Immunology, which runs the pathology service in collaboration with the clinical sequencing laboratory at WashU Medicine’s McDonnell Genome Institute. “Private insurance companies often follow Medicare’s lead in coverage decisions, so we expect that there will be demand for this test across the country. This approval stands as a testament to the vision of WashU physician-scientists Eric Duncavage, Dave Spencer, Molly Schroeder and their team, who spent years developing and validating this test.”  

To Learn More

For an open access 2023 review of AML, see Premnath & Madanat.  For a 2023 paper on molecular cytogenomics in AML, also open access, see Nilius-Eliliwi et al.  For a 2023 German aper on  ALM genomic complexity, open access, see Klever et al

For a 2021 WashU paper on Chromseq, NEJM here.  

  • Extensive orthogonal confirmations were employed.  
    • Writing, "Whole-genome sequencing is a potential replacement for conventional cytogenetic and sequencing approaches."  
  • 16% of patients had a clinically important molecular reclassification.[*]  
  • The CMS coverage came weeks after NCCN included WGS in guidelines for ALM management.  


AI Corner [*]

Compare the original 260 word abstract from NEJM 2021, and a 600 word GPT summary here.


For two 2023 WashU papers on genomics of myeloid malignancies, open access, see Abel et al and Slade et al.


See AML and chromothripsis as an example for using the subscription AI-powered citation database Scite, here.