Medicare contractor Palmetto is proposing to expand coverage to ensure that more patients have access to genomic profiling when tissue-based testing is not possible.
CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.
Palmetto's MolDx has agreed to cover Myriad's MyPath Melanoma to help rule out the disease when the biopsy can't be definitively classified by standard clinical and histopathological characteristics.
The ctDNA test will be covered for all US fee-for-service Medicare patients with advanced (Stage IIIB/IV) NSCLC who meet specific clinical criteria.
The LCD will enable coverage of Envisia in patients for whom imaging does not lead to a definitive diagnosis of idiopathic pulmonary fibrosis.
Following FDA approval last October, Adaptive has now secured Medicare coverage for its NGS-based minimal residual disease assay, ClonoSeq.
The test is a targeted sequencing assay that detects mutations in the blood of non-small cell lung cancer patients to inform treatment selection.
Palmetto proposes to cover the assay for prostate cancer patients who are at very low and low risk of negative outcomes with active surveillance by NCCN guidelines.
The final LCD, which expands Medicare coverage of the firm's ConfirmMDx test to all providers, becomes effective on Sept. 3.
The coverage decision limits the test mainly to patients with advanced lung cancers who haven't been genomically profiled and who can't receive tissue testing.
Bloomberg reports that the DNA-for-cash deal reported in Kentucky might be a more widespread scam.
St. Jude Children's Research Hospital scientists have treated infants with X-linked severe combined immunodeficiency using gene therapy in an early phase study.
St. Louis Public Radio reports that some African Americans are turning to DNA ancestry testing to help guide genealogical searches.
In Nature this week: a genomic analysis of the snailfish Pseudoliparis swirei, ancient DNA analysis gives insight into the introduction of farming to England, and more.