Business
Personalis Enables Global Biopharma Support with CE-IVD Marked Specimen Collection Kits
Personalis Enables Global Biopharma Support with CE-IVD Marked Specimen Collection
About this update from Personalis, Inc.
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.” About Personalis, Inc. At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts, including statements relating to: the attribute...