FREMONT, Calif. - Personalis Inc. (NASDAQ:PSNL) announced today that its EDTA Blood Collection Kit and cfDNA Blood Collection Kit have obtained Class A CE-IVD marking under the European Union’s In Vitro Diagnostic Regulation.
The regulatory clearance allows clinical trial sites in the European Union and Great Britain to use the collection kits for interventional studies, according to a press release statement. The kits are designed to 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.The regulatory win comes as the stock trades at $10.04, with a market cap of $1.05 billion. Despite the positive milestone, shares fell nearly 10% over the past week, though the company has delivered an impressive 86% return over the last year. According to InvestingPro analysis, the stock currently appears overvalued relative to its Fair Value. Investors seeking deeper insights can access the comprehensive Pro Research Report, available for PSNL and 1,400+ other US equities.
The company develops genomic testing for precision oncology. Its products are designed to detect minimal residual disease and recurrence, enable selection of targeted therapies based on genomic profiling, and support biomarker strategy for drug development.
Personalis is based in Fremont, California.
In other recent news, Personalis Inc. reported first-quarter revenue that exceeded consensus estimates, highlighting the significant growth of its NeXT Personal minimal residual disease (MRD) test. The test saw a 258% year-over-year increase and a 26% rise quarter-over-quarter, with over 1,000 oncologists ordering it in the first quarter. The Centers for Medicare & Medicaid Services have expanded coverage for the NeXT Personal test to include monitoring treatment response for specific breast cancer types and immunotherapy monitoring for late-stage solid tumors, further supporting its utilization. These expansions mark Personalis’s fourth Medicare coverage milestone for the test. Meanwhile, BTIG lowered its price target for Personalis to $11 from $13, maintaining a Buy rating, while Needham reiterated a Buy rating with a $12 price target. The company also held its annual meeting of stockholders, where proposals were approved with a significant quorum present. These developments reflect ongoing advancements and investor interest in Personalis’s offerings and strategic direction.
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