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STMicroelectronics, Clonit, Italian Institute Develop Prototype POC Ebola MDx

NEW YORK(GenomeWeb) — STMicroelectronics, Clonit, and Italy's National Institute for Infectious Diseases Lazzaro Spallanzani said today that they have developed a prototype of a portable analyzer which runs an RT-qPCR-based Ebola assay.

The analyzer and assay use whole blood and take about 75 minutes to detect the presence of Ebola virus.

The partners said in a statement that the new device features an extractor element that purifies viral RNA from a few microliters of whole blood. The RNA is then reverse transcribed and amplified on a "stamp-sized silicon microchip" pre-loaded with reagents developed by Clonit, an Italian biotechnology firm that recently developed a quantitative PCR kit to detect the Ebolavirus Zaire strain. The Clonit reagents enable on-chip quantitative real-time PCR, potentially providing viral load data to clinicians. The device also features an optical reader which interfaces with a PC.

The chip and optical reader were contributed by STMicroelectronics, an international semiconductor manufacturer with corporate headquarters in Geneva. That company has IP around dielectrophoresis-based sample prep, a microfluidics chip, and on-chip real-time PCR. Its microfluidics technology also forms the basis for Veredus' VereFlu, VereTrop, and VereMERS assays.

The partners confirmed the sensitivity and accuracy of the new test with a blood sample diluted up to a million times, which could allow earlier detection of infection, and they are currently evaluating an integrated, self-contained, automated system that can run parallel analyses on a large number of samples.

A number of Ebola tests in development are attempting to break free from lab-based RT-PCR, including ones from IDT and Ubiquitome, BioFire Defense, Lucigen, and BioInnovation Solutions, with a number of these firms pursuing Emergency Use Authorization from the US Food and Drug Administration. 

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