Original from: businesswire
Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced that its Personalis EDTA Blood Collection Kit and Personalis cfDNA Blood Collection Kit have obtained Class A CE-IVD marking in compliance with the European Union’s In Vitro Diagnostic Regulation (IVDR).
The CE Mark represents an important regulatory milestone, ensuring that clinical trial sites throughout the European Union and Great Britain can use these collection kits for interventional studies. These kits are specifically designed to maintain the integrity of blood samples required for high-performance genomic analysis, including the company’s ultrasensitive Minimal Residual Disease (MRD) testing with NeXT Personal.
"Our biopharma partners are looking for more than just data; they are looking for a global partner capable of supporting their clinical trials," said Chris Hall, CEO of Personalis. "Securing CE-IVD marking of the specimen collection kits is an important milestone that signals that Personalis is poised to support large-scale, global clinical trials. By standardizing the pre-analytical phase of testing, we ensure that the unprecedented sensitivity of NeXT Personal is available to drug developers on a global level, providing the clear, reliable signals they need to bring new therapies to patients faster.”
Source: Personalis Enables Global Biopharma Support with CE-IVD Marked Specimen Collection Kits
