Natera shared on LinkedIn:
“With today’s announcement that Signatera has received In Vitro Diagnostic Regulation (IVDR) approval in the European Union across many cancers, we are sharing a series of firsts for Signatera from the last two months.
- The 1st personalized MRD test for solid tumors to receive IVDR certification in the EU
- The 1st PMDA-approved MRD test in Japan
- The 1st FDA-approved use of personalized MRD testing to guide treatment decisions
These projects have been in the works for many years. They reflect the determination of employees all around the world – building projects from the ground up to make cancer care better for patients. Read more about our most recent milestone of IVDR certification and what this means for clinical trials, patients, and the field of cancer care.”
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