Genetic analysis systems company Agena Bioscience reported on Wednesday the receipt of the Emergency Use Authorization from the US Food and Drug Administration (FDA) for its MassARRAY SARS-CoV-2 Panel for qualitative detection of the SARS-CoV-2 coronavirus.
Clinical laboratories can process thousands of samples each day for less than USD10 per sample running the assay on the company's single MassARRAY instrument, making it one of the highest throughput SARS-CoV-2 tests available under the FDA's EUA programme.
The company added that the single-reaction panel targets five regions of the viral genome and provides excellent accuracy and sensitivity. It also aims to alleviate material shortages, enabling laboratories to accelerate testing without concerns about instrument or reagent availability.
According to the company, the MassARRAY 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.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA