Near-Oncology Patient (and Near-Oncology Health Care Provider) Molecular Testing on the GeneXpert

Russell Higuchi
Cepheid Fellow R&D, Cepheid, Sunnyvale, CA, USA

In this talk, I will describe our efforts to provide these testing features for cancer diagnostics. In particular, I will cover current and upcoming approved tests for BCR-ABL translocation monitoring in CML patients and for the non-invasive detection of bladder cancer occurrence and recurrence. I will also describe our pilot efforts to develop rapid, bench-top assays to aid the histo-pathologist assess the molecular status of tumors from formalin-fixed, paraffin-embedded biopsy sections. We believe that by bringing such testing directly into the hands of the histo-pathologist, faster and better patient treatment decisions can be made.
Features of the Cepheid GeneXpert molecular diagnostics system include:
1) Full integration of real-time, six-color PCR with an automated sample-prep capable of efficient extraction of large, biologically relevant sample amounts. Samples include sputum, blood, urine and stool.
2) A disposable cartridge format that allows rapid “sample-in, answer-out” with sample and PCR-product containment.
3) A modular, “host” system for the cartridges that provides for process control and multiplex, real-time PCR product detection. Like for computer servers in a rack, the number of modules is expandable as needed – from a single module to 80. Systems with 48 and 80 modules provide for walk-away, automated queuing and loading of sample-filled cartridges.
These features have helped bring the benefits of molecular testing for infectious disease to sites as diverse as the reference lab, the hospital lab and clinics in remote parts of the developing world.

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