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Portable, Rapid MRSA Test that Takes Less Than an Hour Ready for FDA Submission

A portable microfluidics device that can detect the presence of MRSA in fluid samples in less than an hour is ready to apply for FDA clearance.

F Cubed LLC hopes its device will help hospital physicians quickly diagnose pathogens, eventually including pseudomonas and bacterial meningitis, from a small fluid sample.

Its device, called Nesdep, contains disposable biochips that are loaded with DNA from a 10- to 100 microliter-sized sample of blood or wound product. Using carbon nanotubes and AC dielectrophoresis, the biochip traps and quantifies target DNA in the sample in a matter of minutes, said CEO Les Ivie.

The hardware of the device comprises two components: a mechanism that extracts and isolates DNA from the fluid sample, and a second mechanism that moves that DNA through the biochip and connects to an iPad or computer to deliver results.

Nesdep is already available for use in water and food safety testing, and Ivie said his team is meeting with the FDA this month to begin its application process. Initially the biochip will be able to detect only MRSA, but the company expects to release a multi-target biochip by mid-2013, Ivie said. It’s working with an emergency room physician at South Bend’s Memorial Hospital on trials of the device.

About 90,000 Americans are sickened by MRSA each year. Hospital-acquired infections have been a hotbed for innovation as an increasing number of cases have demonstrated resistance to traditional antibiotics. Rapid detection devices already on the market include BD Diagnostics’ BD GeneOhm StaphSR, which was cleared in 2008, and Cepheid’s Xpert MRSA.

Nesdep’s value proposition, according to the company, is that it’s portable enough to run on power from a vehicle’s cigarette lighter, works in as little as 30 minutes without the use of reagents, and costs 10 to 20 percent of what laboratory-based tests cost.

F3 licensed its technology from the University of Notre Dame and is located at Innovation Park in South Bend, Indiana.

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