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Agena Bioscience, Inc.. (8/16/16). "Press Release: Agena Bioscience Expands ISO Accreditation for Genetic Testing". San Diego, CA.

Region Region Brisbane QLD
  Country Australia
Organisations Organisation Agena Bioscience Inc., Australia
  Group Agena Bioscience (Group)
  Organisation 2 National Association of Testing Authorities (NATA)
Products Product MassARRAY® system
  Product 2 quality management services
Person Person Dansky, Peter M. (Agena Bioscience 201407– CEO before Life Technologies + Applied Biosystems + Arcturus + Affymetrix)

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.

About Agena Bioscience

Agena Bioscience develops, manufactures, and supplies genetic analysis systems and reagents, including the MassARRAY® System. The system is a highly sensitive, cost-effective, mass spectrometry-based platform for high-throughput genetic analysis, and is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research. In the United States, the MassARRAY System is intended for research use only, and not intended for use in diagnostic procedures.

Record changed: 2016-10-12


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