Cepheid launches GeneXpert, Xpert BCR-ABL Monitor assay for in-vitro diagnostic use

By Elaine Rigoli

Tampa, Fla., Feb. 23 - Cepheid announced Thursday the European launch of the GeneXpert System for in vitro diagnostic use (IVD), along with the Xpert BCR-ABL Monitor assay, the initial clinical diagnostic test for use with GeneXpert.

Both GeneXpert and Xpert BCR-ABL were released as CE IVD Mark products.

The Xpert BCR-ABL Monitor can be used by hematologist-oncologists as an aid in the monitoring of BCR-ABL, an abnormal genetic marker found in patients with chronic myelogenous leukemia, according to a company news release.

There are about 20,000 patients currently living in remission in Europe with chronic myelogenous leukemia, part of a group of diseases called myeloproliferative disorders.

"The GeneXpert System has been demonstrated to be robust, easy to use and capable of delivering sensitivity and specificity not previously seen in molecular testing," chief executive officer John Bishop said in a statement.

The GeneXpert System and the Xpert BCR-ABL Monitor assay is the world's first closed system, quantitative, nested real-time polymerase chain reaction (PCR) assay, the release said.

The company said this assay will allow health care providers in Europe to obtain timely, highly sensitive and accurate results from a blood sample, with minimal potential for RNA loss or sample contamination.

The GeneXpert System combines sample preparation with real-time nested PCR amplification and detection for fully automated DNA and RNA analysis. The system purifies, concentrates, detects and identifies targeted nucleic acid sequences.

Current techniques for performing the same complex sample prep, reverse transcription and PCR procedures involve skilled technicians in centralized molecular labs performing batched manual tasks that can take two to three days to complete, the release said.

Cepheid, based in Sunnyvale, Calif., is a molecular diagnostics company that develops, manufactures and markets fully integrated systems for genetic analysis in the clinical, industrial and bio-threat markets.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.