Hmmmm, this PR from Natera on 15 May seems on topic for CLOVER and more.
Snip:
I'd need smarter folks than me to share any more solid conclusions but to the unfrozen caveman lay person like me it seems like now, using Natera results, we can more readily convince them to bless the P2 results of CLOVER as meaningful for some sort of accelerated approvals.
While it's a BGO (blinding glimpse of the obvious) for me, y'all are most likely 6 steps ahead of me on this one.
Snip:
Quote:AUSTIN, Texas–(BUSINESS WIRE)– Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved Signatera CDx as a companion diagnostic (CDx) for use with adjuvant atezolizumab (Tecentriq®) immunotherapy in MIBC.
This is the first companion diagnostic approval in the field of blood-based MRD.
Quote:It is a significant milestone in the industry-wide shift toward personalized, MRD-guided cancer care, in which treatment decisions may depend on Signatera™ MRD status, and interventions may be delayed or deferred for patients who remain MRD-negative. Supported by more than 185 peer-reviewed publications and Medicare coverage across multiple cancer types (including Bladder, Breast, Lung, Colorectal, Ovarian, and pan-cancer immunotherapy monitoring), Signatera has become a cornerstone of precision oncology.
I'd need smarter folks than me to share any more solid conclusions but to the unfrozen caveman lay person like me it seems like now, using Natera results, we can more readily convince them to bless the P2 results of CLOVER as meaningful for some sort of accelerated approvals.
While it's a BGO (blinding glimpse of the obvious) for me, y'all are most likely 6 steps ahead of me on this one.
11
