ANN ARBOR–Lynx Dx, developing diagnostic technology for prostate cancer, announced that its MyProstateScore 2.0 (MPS2) has been approved for coverage from Medicare, effective Sept. 11, following a successful technical assessment by Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program.
MPS2, a groundbreaking molecular diagnostic test, measures a panel of 18 urinary biomarkers, delivering insights that can help guide decisions for initial or repeat prostate biopsies. This test has been demonstrated to provide high analytical and clinical validity, aligning with policy L38985 for molecular biomarkers used to risk-stratify patients at increased risk for prostate cancer.
“We are thrilled that MPS2 has gained Medicare coverage,” said Spencer Heaton, MD, chief medical officer at Lynx Dx. “This decision by MolDX reflects the robust evidence supporting the accuracy of MPS2 in clinical practice, empowering providers and patients to make more informed decisions about prostate cancer risk assessment.”
The coverage determination means that patients meeting the policy criteria—those at risk for prostate cancer and candidates for either an initial or repeat biopsy—will now have access to MPS2 under their Medicare plans.
“The comprehensive biomarker panel and strong characteristics of MPS2, coupled with the patient’s clinical findings, give me confidence in deciding who may need a prostate biopsy in the search for high-grade disease,” said Michael S. Cookson, MD, MMHC, FACS, Professor and Chairman of Urology at the University of Oklahoma College of Medicine and Chief of Urology at the Stephenson Cancer Center.
The CPT code for billing is PLA 0403U, and the test is registered under DEX Z-Code® Z02K5.
MPS2 is a urine test designed to predict the presence of clinically significant prostate cancer by analyzing expression of 18 unique gene transcripts. The test optimizes diagnostic accuracy for both biopsy naïve patients and those with a prior negative biopsy. Additionally, it provides diagnostic flexibility with optional assessment of personalized risk factors known to influence the development of clinically significant prostate cancer.
Using technology developed at the University of Michigan, Lynx Dx provides diagnostic testing services through genomic tests.
For more information about Lynx Dx and MyProstateScore 2.0, visit www.lynxdx.com.