Update 5/2023. CareDx full-year guidance; plans layoffs. Here. Share price is $8, vs $15 six months ago, but most of that was due to a half-price cut around March 1, stable since then.
MolDx and other payers move markets. Over a few weeks, Natera is up from $42 to $50 to $56, ending with a market cap of $6.2B. During the same time, CareDx is down from around $16 to $9, ending with a market cap of $480M. Details follow.
Natera Up Again
In a press release March 2, 2023, Natera announces a range of commercial payor coverage for Signatera, a tumor-exome-based minimal residual disease (MRD) test for cancer recurrence. Named plans include Blue Shield of California and BCBS of Louisiana. However, the announcements are also a benchmark for future coverage from other plans on a rolling basis. Ten days earlier, the test had gotten MolDx coverage in breast cancer, here.
As share price has climbed from $42 to $50 to $56, market cap has risen about $1.5B, from around $4.7B to around $6.2B.
CareDx Transplant Documents Revised
There are complicated alterations to statements of policy for the suite of CareDx tests for transplant rejection, and I won't attempt to map all the details in this blog.
(In addition, CareDx refers to its own conversations and Q&A with MolDx, and CareDx has probably made remarks in other investor calls, without aggregating all the details of which, it's impossible to interpret precisely from the new MolDx documents.)
Key documents include:
- CareDx press release on March 3 here.
- The NEW transplant billing article A58019 here. Eff. March 31.
- The Current (now "Old") transplant billing article A58019 here.
- Medicare held a medical-scientific workshop on this area of medicine last year, transcripts are here.
- At the time, I pointed out there was some daylight between the way Palmetto and Noridian described the same meeting - my blog here. In the workshop, some of the statements in the transcript (including from CMS medical directors) seemed skeptical.
- Coverage at "Genomeweb" here, March 3.
- Article: Added four paragraphs.
- Deleted: Table.
- Group 1: Deleted sentence.
Explanation of Changes (Rev 6)
"A reason or justification given for an action or belief."
Article: Added four paragraphs
Deleted: Sentence (section Group 1)
- The new four paragraphs provide four major rules for implementing the transplant LCD, which I clip as "Appendix - 4 Rules."
MolDx has shifted to "foundational LCDs" (also for hereditary cancer testing, and for minimal residual disease testing in all cancers and indications) - which allow specific coverage to be updated by articles or other decisions on a rolling basis, without the time-consuming rules for public notice and public comment. So, for example, breast cancer can be added as a Natera MRD indication, quickly, if MolDx decides its data now justifies coverage under principles in the LCD. However, the policy's implementation can also be changed quickly in other ways - as CareDx found out - for example, by deleting the sentence, "AlloSure Heart is to be billed in conjunction with AlloMap."
CareDx shares popped from $14.70 to $17.80 on the Tuesday the 28th, with its investor call, then slipped to $9 on March 3, ending with a market cap of $480M. Peak to trough almost exactly 50%.