Logo

HiberGene Garners CE Mark for MDx System

Dec 15, 2015 | staff reporter

NEW YORK (GenomeWeb) – HiberGene said today that it has received CE marking for its HG Swift instrument for molecular diagnosis of infectious diseases.

The instrument is designed exclusively for use with the Dublin, Ireland-based company's portfolio of molecular infectious disease assays, including its recently launched HG Meningococcus, a test for bacterial meningitis, and its forthcoming HG GBS, a rapid test for Group B Streptococcus.

All of HiberGene's assays use loop-mediated isothermal amplification, and can provide results in less than an hour. The HG Swift instrument features a small footprint and compact hardware, and is ideal for labs with space constraints and for near-patient testing, HiberGene said. It features touchscreen operation and wireless communication capability.

Filed under

Molecular Diagnostics
Regulatory News & FDA Approvals
PCR
Infectious Disease
CE mark
meningitis
LAMP
Breaking News
The Scan

Machine Learning Helps ID Molecular Mechanisms of Pancreatic Islet Beta Cell Subtypes in Type 2 Diabetes

The approach helps overcome limitations of previous studies that had investigated the molecular mechanisms of pancreatic islet beta cells, the authors write in their Nature Genetics paper.

Culture-Based Methods, Shotgun Sequencing Reveal Transmission of Bifidobacterium Strains From Mothers to Infants

In a Nature Communications study, culture-based approaches along with shotgun sequencing give a better picture of the microbial strains transmitted from mothers to infants.

Microbial Communities Can Help Trees Adapt to Changing Climates

Tree seedlings that were inoculated with microbes from dry, warm, or cold sites could better survive drought, heat, and cold stress, according to a study in Science.

A Combination of Genetics and Environment Causes Cleft Lip

In a study published in Nature Communications, researchers investigate what combination of genetic and environmental factors come into play to cause cleft lip/palate.