national coverage determination
CMS Finalizes Blood-Based Colon Cancer Screening NCD with Non-Coverage for Epi ProColon
The final decision includes some changes, most notably removing requirements for guideline inclusion, but retains its technical performance benchmarks.
Strata Oncology Receives Medicare Coverage for NGS Test
The test assesses multiple factors, including single-/multi-nucleotide variants, short insertions and deletions, and microsatellite instability status.
Germany Grants National Reimbursement for Three Additional Breast Cancer Biomarker Tests
Myriad Genetics' EndoPredict, Agendia's MammaPrint (distributed in Germany by PathoNext), and Veracyte's Prosigna will now be covered by public insurance.
CMS to Cover FDA-Approved, -Cleared NGS Germline Tests for Breast, Ovarian Cancer Patients
The final national coverage decision stipulates that NGS germline tests for assessing hereditary breast and ovarian cancer risk must have FDA's blessing.
The firm is looking to expand its sales internationally, as well as in the consumer-initiated market, but is being conservative with revenue growth estimates.