Instrumentation will use rapid immunomagnetic capture process to isolate pathogens directly from blood.
Stratos Product Development is teaming up with pathogen detection firm nanoMR to develop instrumentation for the latter’s Pathogen Capture System (PCS). The platform uses an immunomagnetic capture process to isolate rare cell types including bacterial and fungal pathogens directly from blood or other samples for further phenotypic or molecular analysis. The system can target multiple cell types simultaneously, or specific cell types, such as circulating tumor cells or fetal cells, in less than 30 minutes.
Founded in 2007, nanoMR’s first product will address the blood culture market. The platform is designed to recover microbial cells directly from blood and deliver purified microbial DNA within just 50 minutes for subsequent analysis using conventional methods such as PCR. The firm says this workflow will enable identification of a causative infectious agent in less than two hours.
nanoMR has brought Stratos on board to develop a cassette and processing system that will use up to 10 mL of blood sample, and generate an output of 50 microliters containing purified DNA. In addition to developing the instrument, Stratos will carry out product requirement definition, hardware and software design with ISO 13485 design controls, and manufacturing strategy and verification to support CE certification for clinical studies in Europe.
“Stratos’ development expertise, combined with nanoMR’s chemistry and research, creates an ideal team to deliver an optimal solution for the market,” remarks Jim Macemon, vp of product development at nanoMR. “We have been impressed with Stratos’ depth of engineering expertise, and their extensive portfolio in diagnostic instrument and medical device development has been invaluable to our effort.”