Thursday, December 28, 2023

Natera Wins Injunction re MRD Testing (versus NeoGenomics)

MolDx has a broad policy allowing use of minimal disease detection (MRD) for cancer management, but MolDx issues coverage step by step, one test and condition at a time.  In July 2023, Neogenomics announced it had won MolDx coverage for its RaDaR molecular test (here).  The coverage is complex and fairy narrow, a signal for other companies seeking MolDx MRD coverage:

[Neogenomics:] Effective as of March 24, 2023, the RaDaR assay is now covered for fee-for-service Medicare patients within the United States with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. The coverage includes patients with a personal history of high-risk stage II/III HR+/HER2- breast cancer, five or more years from diagnosis who presently do not have evidence of disease.  NeoGenomics' tumor informed RaDaR assay has been designed to detect extremely low levels of circulating tumor DNA.

In a new December 28 headline, Natera announces it "has won a preliminary injunction" against Neogenomics for clinical sales of the MRD assay.   I believe the article at Genomeweb here is open access; it contains several links to prior stages and decisions regarding other products.  Neogenomics will appeal.  The case is related to certain tumor-informed approaches to MRD.  Some labs are offering non-tumor-informed technologies for MRD.  The Natera press release, dated 12/27, is here.  A 12/28 headline states, "NeoGenomics Stock Plunges" - here.  The "tumble" was from $20 to $17, circa $250M of market cap.

Additional Details

According to Fierce Biotech, Inivata's owners sold its assets such as RaDaR to NeoGenomics in 2021 for $390M.

Some of the NC case links are here.  One version of the complaint (26pp) is here.  Focus is on Natera '454 and '035 patents.   Details of exactly how the alledged infringement occurs are presented in attachments to the filing at para 38,  "Exhibit 3-4, Exhibits 5-16").