As many readers know, MolDx issues "foundational" or very broad LCDs, and MolDx controls actual coverage and indications by later technological reviews which occur on a test-by-test (company-by-company) basis.
Updated coverage may appear in billing articles attached to LCDs. But MolDx has notified the public a couple years ago that updates may appear, NOT in such LCD/billing articles, but in its separate "DEX REGISTRY" online database. (Here, 5/12/23 & here.)
Often, the first notification is not there, at MolDx, but in press releases. Here are two new examples.
NATERA - LUNG CANCER MRD COVERAGE
On February 25, 2025, Natera issued a press release that its ctDNA test, Signatera, had garnered coverage from MolDx for surveillance for relapse or recurrence in Stage 1-2-3 lung cancer. Find it here:
Natera's announcement includes citations to 3 supporting publications, the largest study with 108 patients and 378 plasma timepoints (of which 10% or about 10 with recurrent disease, which is usually the "N" that drives the study size).
MolDx also covers MRD-type testing for relapse/response decisions in immune checkpoint therapies. See a new review on that space, Vega et al.
BILLION TO ONE - LBx CGP
On April 16, 2025, BillionToOne announced Medicare (MolDx) coverage for its Northstar Select test, which is a liquid biopsy CGP test for actionable tumor genes. It is an 84-gene test, including 19 copy number amlifications and 9 fusions. It is covered for all advanced stage solid tumors. Find it here:
