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Medical Product Development - Pathogen Capture System

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The Medical Product Development team at Stratos worked with nanoMR to develop a Pathogen Capture System.

 

Founded in 2007 by renowned researchers from the University of New Mexico, nanoMR has developed a unique Pathogen Capture System (PCS) that can selectively isolate pathogens for detection at levels as low as 1 CFU/mL by extracting pathogens directly from drawn blood, delivering purified DNA for downstream analysis.

 

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With proven benchtop results and research in place, nanoMR has partnered with Stratos to take their chemistry from bench to market. Stratos is working with nanoMR on the complete product design and manufacturing strategy of disposable cassettes for the company’s Pathogen Capture System and the laboratory device that fully automates their processing. Included in the development effort are product requirements definition, hardware and software design and verification activities, backed by Stratos’ ISO 13485 compliant design controls with output supporting CE certification for clinical trials in Europe.

 

nanoMR came to Stratos with the challenge to develop a cost-effective cassette and processing regimen with an input of up to a 10 milliliter blood sample and output of 50 microliters containing purified DNA. Not only does this require superior product development experience and skill, but also an understanding of the complexities of the chemical and biological processes and the challenges of high-volume design and manufacturing and production of fluid-filled cartridges.

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nanoMR’s resulting Pathogen Capture System will provide substantially faster pathogen identification, enabling the physician to begin appropriate antibiotic therapy sooner and improve patient outcomes while delivering a class-leading user experience for laboratory personnel.

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