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CINCINNATI, OH, United States

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 372.94K | Year: 2008

DESCRIPTION (provided by applicant): The objective of this revised fast-track effort is the development of reliable, high-throughput microfabrication techniques for production of lab-on-a-chip for Point-of-Care Testing (POCT) applications. The proposed fabrication processes will significantly improve the throughput of plastic lab-on-a-chip manufacturing processes while making the process more reliable. The processes developed in this work will allow (a) Siloam to successfully commercialize lab-on-a-chip applications under development and (b) serve as cornerstone of development for the BioMEMS industry by offering fully-automated processes for lab-on-a-chip fabrication. The current plastic lab-on-a-chip production processes include a mix of processes with varying throughput. Low-throughput processes such as drilling, dicing, microfluidic interconnect assembly present significant bottlenecks to the high-throughput desirable of production processes. This effort proposes a systematic development of plastic microfabrication processes that can completely eliminate the low-throughput processes. Furthermore, the newly developed process sequence will allow for a fully-automated process flow which can dramatically enhance the throughput as well as reliability of a production process. During Phase I efforts, research efforts will focus on development of the high-throughput plastic microfabrication processes. A double-side injection molding process is proposed that can enhance the functionality of the injection molding process by allowing for fabrication of (a) through-holes geometries (eliminates drilling), (b) automatic definition of chip size (eliminates dicing), and (c) self-alignment during assembly (increases accuracy and reliability). Also, a novel mechanically-assisted thermoplastic fusion bonding protocol is proposed which can dramatically increase the throughput for the bonding step (few seconds per device). This process relies on a high density array of interlocking pillar-hole structures (fabricated using double-side injection molding) which allows for rapid chip assembly (at room temperature). Following assembly, a batch of assembled chips is simultaneously annealed (at high temperature) which leads to chemical bond formation across the interface. Finally, self-aligning microfluidic interconnects which can be incorporated as a part of the assembly process will be developed. A multi-layer microfluidic device using all of the above processes will be fabricated as a proof-of-concept demonstration vehicle. During Phase II efforts, the merit of the newly developed fabrication processes will be demonstrated by fabrication of lab-on-a-chips for specific BioMEMS applications. The use of the new technology will (a) either improve existing microfluidic devices or; (b) make possible microfluidic devices that were not possible with current fabrication processes. POCT diagnostic tools, using disposable lab-on-a-chips will allow for frequent patient monitoring leading to more informed and clinically relevant decisions from physicians. The manufacturing processes proposed in this work, for microfluidic lab-on-a-chips, are crucial for successful commercialization of this technology.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 997.44K | Year: 2014

Not Available

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 997.25K | Year: 2011

Recent clinical research has established that this ratio is indicative of the activity of the CYP2A6 enzyme that metabolises nicotine. Nicotine is metabolized to COT and then to 3HC. People with high activity of this enzyme, clear nicotine faster and henceneed more nicotine to maintain the addiction. To-date the 3HC/COT ratio could only be determined by specialized measurement techniques such as Liquid-Chromatography/Mass Spectrometry. Although accurate, these tests are expensive and take 2-5 days to deliver results. Smoking is the leading cause of cancer related deaths, and is attributable cause for almost 400,000 deaths per year in the US> The POCT for nicotine metabolites can help in increasing smoking cessation rates and directly contribute to reduced mortality/healthcare burden.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 150.00K | Year: 2010

The goal of this fast-track SBIR project is to develop the first ever, point-if-care test (POCT) to determine the ratio of nicotine metabolites

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 99.64K | Year: 2005

DESCRIPTION (provided by applicant): The objective of this Phase I SBIR proposal is the development of a non-invasive, disposable biochip for the analysis of a panel of breast cancer biomarkers (c-erbB-2 and CA15-3) from saliva. The disposable biochip uses fluorescent immunoassay on a nano-magnetic bead platform to detect the biomarkers. The biochip is fabricated using BioMEMS technology to develop low-cost plastic biochips with integrated saliva sampling and smart passive microfluidic control. The concentration of the breast cancer biomarkers (in saliva) chosen for this work shows good correlation with breast cancer and can distinguish between benign and malignant tumors. The nano-magnetic bead platform is a versatile approach, which allows for separate detection limits for different biomarkers on the same biochip to ensure high sensitivity and specificity for breast cancer diagnosis. Furthermore, the nanomagnetic bead approach also makes it possible to adapt the biochip for detecting a new set of biomarkers without any microfluidic design changes. The integration of the magnetic bead approach (for fluorescent immunoassay) with the BioMEMS technology will allow us to develop a highly sensitive breast cancer biomarker detection chip, which can detect biomarkers across a broad dynamic range from ultralow (~ 5 -10 microliter) saliva volumes. The ultimate goal of this work is to develop a smart disposable biochip for screening a panel of breast cancer biomarkers for home healthcare use. Specific goals of the Phase I are: 1) Develop and demonstrate c-erbB-2 and CA15-3 detection using fluorescent immunoassay on magnetic bead platform. 2) Develop microfluidic biochip for capillarity based sampling of saliva with smart microfluidic control. 3) Integrate nano-magnetic bead immunoassay with smart microfluidic biochip for proof-of-concept demonstration of breast cancer biomarker panel detection.

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