Svetlana Nikic, Founder and Principal of Precision Oncology Consulting, shared on LinkedIn:
“We can all agree that there’s a continuous flow of new information / announcements in the field of Precision Oncology – but how to keep track of that?
Together with my team at Precision Oncology Consulting we will try to offer you weekly updates on key announcements for that past week.
So here we go with the first one:
- FDA eases the regulatory pathway for a category of companion diagnostics
The FDA has reclassified certain ISH companion diagnostic test systems from Class III to Class II, shifting new entrants towards the 510(k) pathway.
Learn more. - MRD moves further into treatment selection
Natera’s Signatera has received another companion diagnostic approval in Japan, this time to guide adjuvant atezolizumab in muscle-invasive bladder cancer.
Learn more. - CHMP recommendations reinforce the importance of biomarker testing in Europe, including ALK-directed treatment in NSCLC.
Learn more.
We will share Precision Oncology Market Signals every week, focusing on what changed, why it matters, and what it could mean for diagnostics, pharma and patient access.
Follow me and Precision Oncology Consulting for the next edition.”
Read more articles featuring Svetlana Nikic on OncoDaily.