Skip to main content
Premium Trial:

Request an Annual Quote

BD Gets FDA Clearance for Enteric Bacterial MDx Test

NEW YORK (GenomeWeb) – Becton Dickinson said today that the US Food and Drug Administration has given it 510(k) clearance for a molecular test that detects infectious diarrhea caused by harmful intestinal bacteria.

The test is an extension to the firm's BD MAX real-time PCR enteric bacterial panel. With the clearance, the majority of pathogens causing acute gastroenteritis leading to hospitalization can be detected rapidly and accurately on the fully automated BD MAX molecular platform, BD said.

It is BD's latest offering in the suite of BD MAX enteric assays that aid in detecting and diagnosing acute gastroenteritis, an inflammation of the gastrointestinal tract.

This panel joins the BD MAX enteric bacterial panel and the BD MAX enteric parasite panel, enabling individualized testing to be performed based on a patient's symptoms and health history, the firm said.

Doug White, vice president and general manager of molecular diagnostics and women's health for BD, said in a statement that the BD MAX system "allows the diagnostic laboratory to perform molecular testing in a flexible, automated manner, enabling timely results and more efficient patient manage­ment."

According to the Centers for Disease Control and Prevention, 1 in 6 Americans suffers from infection due to food-borne illness each year.


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.