A variety of novel oncology tests make up more than half of the tests getting new proprietary laboratory analysis (PLA) codes from the American Medical Association (AMA) that will become effective July 1, according to the Centers for Medicare and Medicaid Services (CMS).
Released by CMS earlier this month as the quarterly update to the Clinical Laboratory Fee Schedule (CLFS) and laboratory services subject to reasonable charge payment, the tests include:
- Two Sebia M-inSight serum-based minimal residual disease (MRD) tests for detecting monoclonal protein (M-protein) in monitoring multiple myeloma.
- Promis Diagnostics EarlyTect BCD, a urine-sample bladder cancer test for people with micro- and gross hematuria. The test reports the likelihood of bladder cancer in relation to the methylated biomarker PENK.
- AnchorDx and DiaCarta's UriFind bladder cancer screening assay that looks for two genes, ONECUT2 and VIM.
- Convergent Genomics' UroAmp next-generation sequencing (NGS) urine test for bladder cancer screening that scouts for 60 genes and MRD status.
- Namida Lab's Auria at-home breast cancer screening test designed for protein biomarkers detected from tears samples, rather than a blood or tissue sample, and produces a risk score.
- Global Diagnostics Labs and PreTect AS's Proofer 7 HPV-mRNA E6 and E7 Biomarker Test, a gene expression profiling of 14 biomarkers as part of human papillomavirus (HPV) screening.
- Sysmex Inostics' HPV-SEQ NGS test for MRD in oropharyngeal cancer that evaluates eight DNA targets.
- Exact Sciences' Cologuard Plus colorectal screening test for certain methylated DNA markers and protein markers.
- Breakthrough Genomics and Singlera Genomics ColonAiQ multigene colorectal cancer cell-free DNA liquid biopsy screening test that reports the presence or absence of circulating tumor DNA.
- EntroGen's CRCdx RAS Mutation Detection Kit for 35 variants of KRAS and NRAS genes in colorectal cancer.
- Tempus AI's xT CDx 648-gene NGS companion diagnostic test for solid tumor profiling.
- GoPath Diagnostics' GeneticsNow Comprehensive Germline Panel, a hereditary pan-cancer NGS test that analyzes 88 genes associated with genetic disorders and reports positive or negative for germline variants for each gene.
- GoPath Diagnostics' ProstateNow Prostate Germline Panel for people with prostate cancer or who have a family history of prostate cancer. The test evaluates 23 genes and tests for rare pathogenic mutations. The test also issues a genetic risk score.
- OneOme's RightMed pharmacogenomics and genetic test that looks for 24 genes and reports gene-drug interactions.
CMS will hold the annual Clinical Laboratory Fee Schedule (CLFS) public meeting regarding new and reconsidered clinical diagnostic laboratory test codes for calendar year 2025 Tuesday, June 25. Deadline for submissions is May 30 at 5 p.m.
See all tests included in the CLFS quarterly update here.
