Fast System for in Vitro Diagnostics

An in vitro diagnostic system can be used by laboratorians and hematologist-oncologists as a fast aid to detect a genetic marker found in patients with chronic myelogenous leukemia.

The GeneXpert system and the Xpert BCR-ABL Monitor assay, the initial diagnostic test for use on the system, constitute the world's first closed system, quantitative, nested real-time polymerase chain reaction (PCR) assay. Both are being introduced to Europe and have received the CE Mark. The assay allows healthcare workers to obtain fast, near-patient, 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 the targeted nucleic acid sequences, while the BCR-ABL assay provides results in about two hours.

"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,” noted John Bishop, CEO of Cephid (Sunnyvale, CA, USA), which developed the system. "In the European clinical molecular diagnostics market, the ability of the clinician to obtain immediately actionable intelligence is critical to patient management.”

The GeneXpert system is now the only real-time PCR platform that integrates microfluidic sample preparation with the sensitivity of real-time PCR-based molecular detection. Current techniques for performing the same complex sample prep, reverse transcription, and PCR procedures involving skilled technicians in centralized molecular labs performing batched manual tasks can take two to three days to complete.



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