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

Personalis Inc. (NASDAQ: PSNL) announced that its EDTA Blood Collection Kit and cfDNA Blood Collection Kit received Class A CE-IVD marking under the European Union's In Vitro Diagnostic Regulation.

The regulatory approval allows clinical trial sites in the European Union and Great Britain to use the collection kits for interventional studies. The kits maintain blood sample integrity for genomic analysis, including the company's Minimal Residual Disease testing with NeXT Personal.

"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," said Chris Hall, CEO of Personalis. "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."

The CE Mark enables global deployment of Personalis' ultrasensitive MRD detection technology for drug development programs. The company develops personalized testing for cancer management and provides genomic profiling services for pharmaceutical partners.

Personalis is based in Fremont, California, and focuses on advanced genomics for precision oncology applications.

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