Bryan Haffer, Sr. Director, Business Development at Natera, shared a post on LinkedIn:
“In a matter of weeks, Signatera™ has redefined what a molecular residual disease test can do – for patients, for oncologists, and for the biopharma partners building the next generation of cancer therapies:
- First-ever FDA-approved blood-based MRD companion diagnostic – Signatera CDx is now approved to guide adjuvant Tecentriq® (atezolizumab) in muscle-invasive bladder cancer, powered by the practice-changing Phase III IMvigor011 trial.
- NCCN Category 1 recommendation – the highest designation – for Signatera-guided adjuvant immunotherapy in MIBC. Our third ctDNA-MRD guideline inclusion, following Merkel cell carcinoma and DLBCL.
- EU IVDR Class C certification – bringing Signatera MRD testing to patients across Europe.
- First PMDA-approved MRD test in Japan – approved for colorectal cancer, with commercial launch planned this year.
Why this matters for our pharma partners:
Signatera didn’t just get approved – it generated the Phase III evidence that changed the standard of care. That’s the difference between a biomarker and a co-development engine.
For biopharma, this is the blueprint for Treatment on MRD (TOMR): enrich trials with the patients most likely to benefit, read out earlier with a validated ctDNA endpoint, and carry a regulator-cleared, guideline-embedded companion diagnostic all the way to label. With >90% MRD market share and a proven CDx pathway across the US, EU, and Japan, Natera is the partner that turns MRD strategy into approvals.
The shift to MRD-guided cancer care is here. Let’s build what’s next – together!”
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