San Diego, CA – Agena Bioscience, a global provider of low cost and high-throughput molecular testing solutions, today announced that it has obtained CE-IVD marking for its SARS-CoV-2 Panel, an in vitro diagnostic test for the qualitative detection of the SARS-CoV-2 coronavirus that causes COVID-19.
Clinical laboratories can process more than 6000 samples each day running the assay on a single MassARRAY® instrument, making it one of the highest throughput SARS-CoV-2 tests available. Priced at under 10 € per sample, the panel makes large-scale testing more accessible.
“The MassARRAY technology from Agena Bioscience was instrumental for HeartGenetics’ fight against COVID-19 in Portugal,” said Prof Ana Teresa Freitas, CEO of HeartGenetics, Genetics and Biotechnology SA, based in Portugal. “Reliable supply of reagents and the ability to test large numbers of samples per day at a low cost were key factors in us choosing this platform.”
With the panel’s launch in Europe, Agena also aims to alleviate material shortages, enabling laboratories to accelerate testing without concerns about instrument or assay availability.
“Agena is proud to offer a truly scalable platform to support the increasing demand for high-throughput SARS-CoV-2 testing in Europe,” said Peter Dansky, CEO of Agena Bioscience. “We have proactively sourced and secured materials to provide uninterrupted product availability to our customers. Agena’s SARS-CoV-2 kits and MassARRAY systems are ready for immediate deployment and we are equipped to supply millions of tests each month.”
The single-reaction panel targets five regions of the viral genome, providing the accuracy and sensitivity required in the evolving landscape of SARS-CoV-2 testing.
“As the number of people being tested increases, panel sensitivity will be critical to ensuring proper patient management,” said Dr. Darryl Irwin, Vice President of Scientific Affairs. “The SARS-CoV-2 Panel exhibits a limit of detection of 0.4 copies per uL. Labs can test large numbers of samples without sacrificing accuracy.”
More information is available at www.agenabio.com.
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. For more information about Agena, visit www.agenabio.com.