NEW YORK (GenomeWeb) – Guardant Health said today that Medicare contractor Palmetto GBA has finalized its local coverage determination for the Guardant360 liquid biopsy assay in non-small cell lung cancer.Â
The LCD — which was issued as a draft in May and will become effective in its finalized version for testing provided on or after Aug. 27 — sanctions coverage of the comprehensive genomic profiling test for US Medicare patients with metastatic NSCLC who meet certain clinical criteria.
To be reimbursed, tests must be performed on patients with Stage IIIB or Stage IV cancers. At diagnosis, the test is covered only in patients who have not yet had tissue testing, and in whom tissue testing is deemed infeasible based on a lack of biopsy material or a medical contraindication to a biopsy. The test is also covered for patients at progression on or after chemotherapy or immunotherapy who have not been tested with a tissue-based assay and for whom such testing is infeasible, or for patients progressing on any tyrosine kinase inhibitor.
If no genetic alteration is detected by Guardant360, or if circulating tumor DNA levels are too low to analyze, physicians are instructed to consider tissue-based genotyping.
According to the LCD documentation, evidence of utility for Guardant360 in testing for patients with advanced NSCLC as described, is "quite promising." However, the Medicare contractor reported that continued coverage for the test is dependent on annual review of new data and publications.
Guardant's most recent major publication on the test was a validation study in Clinical Cancer Research this April, which showed a positive concordance between Guardant360 and tissue genotyping of 92 percent to 100 percent in detecting treatment-relevant alterations in EGFR, ALK, ROS1, BRAF, MET, and KRAS.
The company also highlighted the fact that lung cancer guidelines increasingly call for broad molecular profiling to optimize treatment planning, with some — like those of the National Comprehensive Cancer Network — now also endorsing the use of plasma-based tests when tissue is not available.