Skip to main content
Premium Trial:

Request an Annual Quote

Cepheid's HIV MDx Assay Gains CE-IVD Mark

NEW YORK (GenomeWeb) – Cepheid and the Foundation for Innovative New Diagnostics today announced that the Xpert HIV-1 Viral Load has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices.

The test runs on Cepheid's GeneXpert System and is the eighth product release from the company this year, marking Cepheid's "entry into the foundational elements of the virology market and [extending] our menu of Xpert tests to 20 outside of the US," Cepheid Chairman and CEO John Bishop said in a statement. The assay is expected to start shipping in February 2015.

Citing statistics from the World Health Organization, Cepheid and FIND said that more than 35 million people globally have HIV/AIDS and added that people with HIV are 26 to 31 times more likely to develop tuberculosis compared to those without HIV. TB is the most common presenting illness among HIV patients and is a major cause of HIV-related death.

"Given the challenges presented by HIV and TB co-infection, we believe that Xpert HIV-1 Viral Load will be an excellent addition to Xpert MTB/RIF, dramatically improving endemic countries' capacity to diagnose and manage these infections," FIND CEO Catharina Boehme said.

In October, FIND, Cepheid, and Rutgers New Jersey Medical Schoolsaid they would develop a next-generation test for Mycobacterium tuberculosis called Xpert MTB/RIF Ultra for detecting patients with smear-negative TB, which is often associated with HIV co-infection.

The Scan

Team Tracks Down Potential Blood Plasma Markers Linked to Heart Failure in Atrial Fibrillation Patients

Researchers in BMC Genomics found 10 differentially expressed proteins or metabolites that marked atrial fibrillation with heart failure cases.

Study Points to Synonymous Mutation Effects on E. Coli Enzyme Activity

Researchers in Nature Chemistry saw signs of enzyme activity shifts in the presence of synonymous mutations in a multiscale modeling analysis of three Escherichia coli genes.

Team Outlines Paternal Sample-Free Single-Gene Approach for Non-Invasive Prenatal Screening

With data for nearly 9,200 pregnant individuals, researchers in Genetics in Medicine demonstrate the feasibility of their carrier screening and reflex single-gene non-invasive prenatal screening approach.

Germline-Targeting HIV Vaccine Shows Promise in Phase I Trial

A National Institutes of Health-led team reports in Science that a broadly neutralizing antibody HIV vaccine induced bnAb precursors in 97 percent of those given the vaccine.