Genosafe Advances CLIA Pathway to Expand CRO Genomic Testing Capabilities

• Genosafe is advancing its CLIA certification pathway to expand genomic testing services for biopharma and CRO clients in the United States.

• The move supports the company’s transatlantic strategy to integrate European and U.S. clinical testing capabilities for cell and gene therapy development.

Genosafe announced progress toward Clinical Laboratory Improvement Amendments (CLIA) certification as part of its strategy to expand genomic testing services in the United States. The initiative is designed to strengthen the company’s transatlantic clinical testing infrastructure and support biopharma and contract research organization (CRO) clients developing advanced therapies.

The CLIA pathway will allow Genosafe to provide clinical-grade genomic testing services directly within the U.S. market, complementing its existing European laboratory operations. According to the company, the expansion is intended to improve access to compliant testing services for sponsors conducting global clinical development programs, particularly in cell and gene therapy.

From a CRO perspective, the move reflects increasing demand for integrated testing and regulatory support across multiple regions. Sponsors developing advanced therapies often require harmonized genomic analysis, biosafety testing, and regulatory alignment between Europe and the United States, driving investment in cross-border laboratory capabilities.

Genosafe indicated that the expanded infrastructure will support translational research, clinical trial testing, and companion diagnostic activities. The company also noted that strengthening its U.S. presence is expected to improve turnaround times and operational coordination for multinational development programs.

“Advancing toward CLIA certification represents an important milestone in our strategy to provide integrated transatlantic genomic testing services for clients developing innovative therapies.”

Jean-Marc Grognet, Chief Executive Officer of Genosafe