Monday, February 26, 2024

Very Brief Blog: Natera Wins MolDx Coverage for MRD in Neoadjuvant Breast Cancer and in Ovarian Cancer

Header:  Natera, which provides the bespoke (patient-tailored) Signtera test for minimal residual disease, wins MolDx coverage for breast and ovarian cancer.


Natera's Signatera test, which screens for minimal residual disease with a bespoke test that is custom-tuned to each patient's prior tumor exome or large panel, adds more Medicare coverage from MolDx.

Coverage is for use in neoadjuvant breast cancer therapy (chemotherapy given prior to the initial lumpectomy), the first coverage of this category for MolDx.   In another first, Natera also announced coverage for MRD in ovarian cancer.

See the press release here:

The Natera Press Release - Structure and Function

In January, I wrote a blog article about how the Natera CEO presentation at JP Morgan was richly infused with facts and capabilities about their reimbursement expertise and tactics (here).  

Natera's new press release, just cited, is worth studying for its use of carefully footnoted facts, call-outs to guidelines, and links to key supporting publications (#4, #7).  The press release even includes selected citations to the size of population studied, number of unique biosamples, and some statistics.  The study cites pivotal publications in 2022 and 2023, which is related to MolDx reliance on published trials, and MolDx timeline (counted in quarters) for review of new indications not covered before.

Both key publications (Hou 2022 in ovarian and Magbanua 2023 in breast) are open access.  Example of the data power are shown in Hou 2022, Fig 3, where ctDNA+ relapse rate was 13%, vs 75% in ctDNA+.  Although the "N" gets smaller +20 months, relapse rate for ctDNA- remains low.

Hou 2022; Ovarian; Click to enlarge

The Magbanua paper includes online supplemental data such as patient-level Excel charts.

Magbanua 2023; open access patient level data in Excel


See open access coverage at Genomeweb here;