You'll be excused for getting lost in the chain of events around MolDx and coverage for transplant rejection by means of donor-DNA assays. In January 2026, Craig-Hallum (investors) downgraded CareDx stock over continuing LCD uncertainty.
This led to several news reports, but over the past 30 days, it looks like the stock has traded in a narrow band from $19 to $20. We'll hear more at JP Morgan next week.
What Happened Over Time?
MolDx has covered donor-DNA assays for transplant rejection, available from both CareDx and Natera, for a number of years.
Back around March 2023, MolDx (meaning the Noridian MAC, which handles California claims) made some changes in claims processing that caused a stock drop at CareDx. (Here.) Later, MolDx put out a slightly revised LCD, with statements that the changes were only clarifying. However, there was another round of agitation. [My blog at the time, here.] Eventually, that "proposed LCD" was retired without finalization. However, in summer 2025, MolDx put out a more heavily revised LCD, as a "new LCD" with a new tracking number. The comment period ran for 45 days. Unlike comments on NCDs, comments on LCDs are not published by CMS. [My blog at the time, here.]
- Since the "new LCD" in summer 2025 was lliterally "new," it's harder to compare the impact of the older and newer version easily, like you can when one can be redlined against the other.
Along the way there were at least 4 or 5 pieces in the Wall Street Journal, like this one.
So now we're in the ongoing wait for a "new final LCD" on donor DNA transplant testing. That's where the "new news" comes in.
What Happened This Week?
Investment group Craig-Hallum downgraded CareDx from "buy" to "hold." See Investing.com here (email registration required). See a short piece at StreetInsider.com here. See a subscription article at 360Dx here.
Some text from StreetInsider.com:
- The analyst comments "With CDNA shares having fully recovered to where they were before MolDX issued its restrictive draft LCD back in July, the risk-reward appears less compelling. At this point, 2026 revenue and longer-term growth will be highly dependent on the shape of the final LCD. We can conceive of a scenario where next year’s numbers are too high and longer-term growth opportunities are less robust...[but] 2026 estimates could prove conservative (and our downgrade could prove overly cautious) if the final LCD is meaningfully less onerous than the draft LCD..."
