Company News: Agena Bioscience Expands ISO Accreditation for Genetic Testing

Agena Bioscience today announced accreditation of its Assays by Agena facility in Brisbane, Australia, under ISO/IEC 17025 in the field of biological testing for determinations of SNP Genotyping, somatic mutation detection, and quantitative methylation analysis using its MassARRAY® System.

The accreditation comes from the National Association of Testing Authorities, or NATA, and ensures that member facilities comply with standards and provide accurate data generation, controlled test methods and procedures, and properly trained personnel.

Agena Bioscience CEO Peter Dansky commented, “Accreditation of our facility in Brisbane demonstrates the company’s commitment to advance the MassARRAY System into the clinical market, and ensure consistent, valid, and robust results under documented quality management systems.”

The Assays by Agena facility in Brisbane offers highly cost-effective and adaptive testing services and custom panel development. In particular, the facility will offer a multiplexed solution for detecting rare variants in liquid biopsies as low as 0.1% frequency. “Detection of rare variants in tissue biopsies and minimally invasive liquid biopsies is a rapidly emerging field, well suited to the accuracy, sensitivity, flexibility and short turnaround time of the MassARRAY System. This enables valuable insight into genetic changes that may occur during the course of diseases such as cancer,” Dansky elaborated.

The ISO/IEC 17025 accreditation follows the company’s success in achieving significant milestones to enter the clinical diagnostics market. Earlier this year, Agena Bioscience launched two CE-IVD marked MassARRAY diagnostic products for in vitro testing of colon and lung tumors. The company previously received ISO/IEC 13485 certification of its San Diego facilities to develop, manufacture, and distribute its MassARRAY System, software, and reagents for life sciences.