NEW YORK — MagBio Genomics said on Monday that it has received US Food and Drug Administration 510(k) clearance, as well as CE marking, for its MagXtract Collection Tube for viral sample collection.
According to MagBio, the tube contains guanidine-free molecular transport medium and is designed for the collection and processing of viral samples for clinical molecular testing, including for COVID-19 and influenza. It may also be used for research applications with bacterial and fungal samples, the Gaithersburg, Maryland-based company said.
"Poor sample stabilization results in nucleic acid degradation and overgrowth of some micro-organisms, which may lead to patient misdiagnosis," MagBio CEO Hyacinth Ntchobo said in a statement. "The MagXtract Collection Tube addresses these issues by providing cost-effective room temperature sample transportation and nucleic acid stabilization over prolonged time, providing clinical laboratories with high-quality samples for accurate molecular detection of pathogens."