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Plastic Microfluidic Chip for Isoloation of Nucleic Acids from Biological Samples

Organization:Boston University, MA, US
I.P. Brief:Point-of-care, disposable plastic microfluidic chip based system for solid phase extraction and isolation of biomolecules from biological samples.
Summary of I.P.:The technology is a true platform technology that enables rapid, specific, low-cost detection of pathogens or protein biomarkers at hte point of care. Resultant products may include point-of-care diagnostics that directly influence treatment protocols or low-cost diagnostics that can be peformed in remote areas with no access to laboratory equipment or even nursing homes or long-term care facilities with no central laboratories. Candidate corparte partners may include: molecular diagnostic companies (e.g. Invitrogen), rapid microbiology tests companies (e.g. Becton Dickinson), or nucleic acid isolation equipment companies (e.g. Tecan). Further the technology is appropriate for non-profit global health initiatives.
Patent:Provisional patents filed, utilty application in preparation.
Keywords:Nuleic Acid, Isolation, Solid Phase Extraction, Microfluidics, Molecular Diagnostics, Diagnostics
Primary Industry:Health & Medical Devices
Specific Market:Nucleic Acid Separation
Market Size:The total nucleic acid separation market (including kits, consumables, and capital equipment) was $295 million in 2004 with a compound annual growth rate projected at 10%. The total market for molecular diagnostics was $984.3 million in 2003.
State of the Art:There are other technologies for performing molecular diagnostics (e.g. microarrays, FISH, etc.). There are other technologies for separating nucleic acids (e.g. charge switch)
Figures of Merit:sensitivity, specificity, turn around time, ease of use and cost. The technology is expected to compete favorably in these areas. The plastic chips and separation technology have been designed for high volume manufacture.
Tech.  Obstacles:Nucleic acid separation has been completed. Work underway regarding the integration of upstream and downstream processes to complete full on-chip diagnostic system. Additional work is being conducted with clincial samples (e.g. stool, sputum, etc.) in order to show the robustness of the technology.
Market Obstacles:In order for this technology to compete competitively it must peform favorably in sensitivity, specificity, turn around time, ease of use and cost. The nucleic acid separation technology is effective and proof of principle has been demonstrated. The results of work currently underway using clincial sample will provide data to support the expecations that this technology will provide competitive advantages in the field of rapid, low-cost diagnostics.
Patent Landscape:There is related prior art using solid phase extraction in glass microfluidic chips, polymer matrices in microfluidic channels (without silica beads), and solid phase extraction in general terms.
Publications:Bhattacharyya A, Klapperich CM \"Thermoplastic Microfluidic Device for On-Chip Purification of Nucleic Acids for Disposable Diagnostics\" Anal. Chem. : (2005)
Research Team:Catherine M. Klapperich Ph.D. Assistant Professor, Biomedical Engineering Assistant Professor, Manufacturing Engineering


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