Skip to main content
Premium Trial:

Request an Annual Quote

MagBio Genomics Gets 510(k) Clearance, CE Mark for Viral Sample Collection Tube

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."

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.