Personalis gets CE-IVD marking for blood collection kits in Europe

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Personalis Enables Global Biopharma Support with CE-IVD Marked Specimen Collection Kits

June 9, 2026 6:00 AM EDT

Regulatory milestone for specimen collection kits enables global deployment of Personalis ultrasensitive MRD detection (Next Personal®) for drug development programs

FREMONT, Calif.--(BUSINESS WIRE)-- 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 Unions 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... More