Skip to main content
Premium Trial:

Request an Annual Quote

Mobidiag Bacterial Gastroenteritis Assay Gets CE Mark

NEW YORK (GenomeWeb) — Finnish molecular diagnostics firm Mobidiag said today that its Amplidiag Bacterial GE assay has received CE IVD marking and is now commercially available in Europe.

Amplidiag Bacterial GE is an in vitro diagnostic test indicated to aid in the diagnosis of patients suspected of bacterial gastroenteritis. It uses qPCR to rapidly and qualitatively detect in stool samples eight gastroenteritis-causing bacteria: Campylobacter; Salmonella; Shigella/enteroinvasive Escherichia coli; Yersinia; and enterohemorrhagic, enteropathogenic, enteroaggregative, and enterotoxigenic E. coli.

The test provides same-day results that should be used in conjunction with other clinical and laboratory findings.

CE marking follows the successful completion of a two-center performance evaluation study of 1,235 patient samples and 125 spiked samples, with the test showing an overall sensitivity of 99.0 percent and specificity of 99.9 percent when compared with routine stool culture and independent nucleic acid-based methods, Mobidiag said.

In 2013, Espoo-based Mobidiag successfully completed a three-way merger with Genewave and Amplidiag, solidifying its position in the field of molecular diagnostics.

The Scan

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge is weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.