2020 continues to be a big year for the MRD and treatment response monitoring market, as this week, CMS released a draft LCD for “Minimal Residual Disease Testing for Cancer”, which expands upon covered use cases from the final LCD Natera Signatera received earlier this month. Of note, highlights of the proposed LCD in comparison to the previous final LCD include:
- The expanded LCD is pan-cancer, vs. colorectal cancer only, noting that MRD testing and validation studies have been performed in multiple cancer types (both solid tumors and hematopoietic malignancies)
- DeciBio Note: To date, most of the focus has been on MRD for CRC Stage II & III given the high perceived utility in this space and established use case for blood-based testing with CEA. However this LCD could greatly accelerate the adoption of other MRD / ctDNA monitoring use cases
- Coverage of therapy response monitoring, specifically calling out immunotherapy monitoring
- DeciBio Note: Improved methods of predicting and detecting IO response could significantly reduce unnecessary treatment, associated costs, and side effects; however, clinician willingness to take patients off of IO upon detection of non-responders is yet to be seen and may impact actual clinical adoption in this setting. In the INSPIRE study published in Nature Cancer last month, 11 of the 30 patients who showed ctDNA increases continued to receive additional cycles of pembrolizumab despite having early progression. Natera (via Foundation Medicine) and Guardant are both decently well-positioned in this space from the perspective of commercial reach
- The test should be “considerably more accurate than other established (non-MRD) forms of surveillance or monitoring” and “medically acceptable that the test being utilized precludes other surveillance or monitoring tests unless they are required to follow-up or confirm the findings of this test”
- DeciBio Note: In CRC and other cancers, ctDNA testing has shown to be more sensitive and detect recurrence with lead times over current methods (including CEA and imaging). CEA is known to be a mediocre marker for surveillance, so MRD assays should see limited push back here. However, whether MRD assays will be broadly used in place of imaging is yet to be determined – given the strong entrenchment of imaging methods, we expect the actual clinical implementation will be impacted by clinician preference.
- To receive coverage, the test performance of an assay must be comparable to that of existing tests that are already covered
- DeciBio Note: We expect that this provides Signatera with a competitive edge given their first-to-coverage status to-date
The running list of companies vying for the MRD market (to varying extents) now includes Natera (& Foundation Medicine via partnership), Guardant, Archer DX, Inivata, Caris, GRAIL, Exact Sciences, and Genosity.
In the early detection space, Exact Sciences presented data on their multi-cancer liquid biopsy test, demonstrating overall 86% sensitivity and 95% specificity across esophageal, liver, lung, ovarian, pancreatic, and stomach cancers. Although Exact Sciences enters the early detection space behind key players (GRAIL, Guardant, Thrive, to name a few), we expect that their commercial reach in the primary care physician segment developed through Cologuard in addition to promising preliminary sensitivity/specificity (albeit in a limited data set not concentrated in early stage) can likely set them up for success.
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