ChromoSeq, an advanced diagnostic assay developed in the Department of Pathology & Immunology at Washington University School of Medicine in St. Louis, was recently approved for reimbursement by The Centers for Medicare & Medicaid Services (CMS), a milestone for test developers and a win for patients with myeloid malignancies. The test is based on whole genome sequencing (WGS) that provides a comprehensive genomic assessment of newly diagnosed patients with AML and MDS. ChromoSeq was developed by Eric Duncavage, MD, Molly Schroeder, PhD, and David Spencer, MD, PhD. Research and development of the assay were supported in part by funding through grants from the National Center for Advancing Translational Sciences and Alvin J. Siteman Cancer Research Fund.
“I’m excited to announce that our ChromoSeq CAP/CLIA clinical assay was approved for use in Medicare patients with AML and MDS. As far as I know, ChromoSeq is the first WGS-based assay for cancer to be covered by Medicare. This is a huge win for AML and MDS patients who will now be able to benefit from advances in genomic testing,” Duncavage said.
“The recognition of the power of ChromoSeq as the first WGS test to be approved for reimbursement by CMS is a testament to the vision of Eric, Molly, Dave and their team, and to the power and clinical validity of the assay in assessing patients with the deadly diseases of the blood system. This test is already in routine use by WashU oncologists, and we expect that there will be demand for this test across the country,” said Richard J. Cote, MD, Edward Mallinckrodt Professor and Chair, Department of Pathology & Immunology, Washington University School of Medicine.