HEARTDECODE® Software and Assays Designed for Use with the MassARRAY® DX System
San Diego, CA, July 18, 2017– Agena Bioscience today announced a co-promotion agreement leveraging its MassARRAY® DX clinical diagnostics technology with HeartGenetics’ CE-IVD marked products for cardiovascular testing.
The MassARRAY DX, a CE-IVD marked system, provides a streamlined and cost-effective workflow for labs enabling parallel analysis of mutations (SNPs, InDels, rearrangements and copy number variants). Tens to hundreds of medically-actionable or known predictive genetic variants can be screened across 100s of patient samples in a single day. The flexibility and scalability of the platform permit mid- to large-scale sample throughput which provides the means for highly efficient lab production.
As a leader in genetic tests and computational tools designed to support clinical diagnosis and the prevention of cardiovascular disease, HeartGenetics will provide HEARTDECODE® software and assays designed for use with the MassARRAY System. HEARTDECODE® software provides highly accurate and reproducible analysis with the integration of both genetic and pharmacogenetics data and medical guidelines.
“Computational biology companies with clinical expertise are crucial for realizing the full potential of personalized medicine. We are proud that HeartGenetics, one of the key entrepreneurs in digital health care, has chosen to partner with Agena,” said David Coorey, Vice President and General Manager, EMEA at Agena Bioscience.
HeartGenetics, a spin-off from Tecnico Lisboa, has developed new certified CE-IVD medical devices, which include genetic tests and AI software tools for data interpretation, to assess the individual risk for conditions such as Hereditary Thrombophilia (TRB), Arterial Hypertension (AHTN), Hypertrophic Cardiomyopathy (HCM), and Familial Hypercholesterolemia (FH). Additionally, the clinically relevant genetics tests of Warfarin, Clopidogrel and Simvastatin pharmacogenetics are included.
Ana Teresa Freitas, Chief Executive Officer of HeartGenetics, commented, “We are excited to have the opportunity to partner with Agena Bioscience, whose MassARRAY technology provides an ideal platform for robust, cost-effective clinical diagnostics. Together we will be able to promote cardiovascular health to many patients with accurate, actionable and affordable testing.”
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.
In Europe, the MassARRAY Dx by Agena Bioscience is a CE-IVD marked genetic analysis system that enables reliable multiplexed analysis of up to hundreds of clinically relevant mutations in a single workflow. Powered by sensitive and accurate mass-based detection, the MassARRAY Dx maximizes laboratory resources with rapid turnaround time and clinically actionable mutation reports. www.agenabio.com
HeartGenetics, Genetics and Biotechnology SA is a Portuguese biotech and bioinformatics company developing new medical devices (genetic testing kits and AI software tools) that makes genetic testing simple, actionable and cost-effective and that can be used on cardiovascular diagnosis, pharmacogenetics and nutrigenetics. www.heartgenetics.com