SBIR-STTR Award

This Small Business Innovation Research Program Phase I project proposes a new instrument for imaging live cells and tissues. The instrument addresses the current shortcomings of state-of-the art techniques: expensive and invasive contrast agents that bias the results and shorten the lifetime of the experiment, extensive sample preparation and high power light sources required for good image contrast. The technology behind the instrument - Quantitative Phase Imaging (QPI) requires no sample preparation and affords long term (days/weeks) quantitative imaging of live, unstained cells and tissues at a fraction of the cost of a research grade microscope. Customer discovery results will drive the research objectives for Phase I: 1) development of a minimum viable product (MVP) that will satisfy the most common requirements of life sciences users, 2) developing the operating software for the MVP and 3) preliminary design of the Phase II fully automated quantitative phase imaging system. Phase I research efforts will deliver a prototype with two components: the hardware module that snaps onto existing off-the-shelf optical microscopes, and the software module, which affords data acquisition, phase decoding, displaying, and analysis. The software will include optional toolboxes that will be application specific. The broader impact/commercial potential of this project is that it will improve human health at several different levels and will contribute toward maintaining the United States edge in the area of high-tech biomedicine. Initial target market for the QPI-based instrument consists of scientists with access to research grade microscopes in the biotech and pharmaceutical (Bio-Pharma) industry and academia. Major OEMs of scientific instruments have asked for licenses to integrate various ranges of the QPI technology into their systems. The instrument enables novel cancer drug discovery by accurate, label-free monitoring of cell response to treatment, automatic cancer diagnosis of biopsies and blood testing, enhances fundamental understanding of cell function (differentiation, proliferation, and death). Due to its full automation, the QPI-based instrument can operate in areas with limited access to trained personnel and provide the digital data necessary for remote diagnosis. The obtained images are quantitative, meaning that there is no calibration necessary when operating the instrument at different sites. These features recommend the QPI technology for applications of global coverage, such as screening for malaria in under-served populations of the United States and the World.

This Small Business Innovation Research Phase II project proposes to develop a faster and more accurate optical instrument for studying live cells and tissues. The study of live cells has yielded numerous discoveries (e.g. germ theory, the Krebs cycle, cell division) and is important for drug discovery and disease treatment. Live cells are transparent and need to be observed for long periods of time (days, weeks) in their natural state. To make the cells visible and measure them quantitatively, current state of the art instruments require injecting the cells with staining agents or light emitting fluorophores. Both processes are invasive, labor intensive and expensive and long term observations of live cells is difficult: staining embalms the cells and the fluorophores fade quickly and kill the cells in hours. The Phase I project produced a proof-of-concept prototype that provides quantitative imaging of live cells by processing the light transmitted through the cells in their natural state. Completion of the Phase II objectives will upgrade the Phase I prototype to a commercial grade instrument: improve optical design and build a housing enclosure, develop commercial grade software and automate the hardware controls and develop task-specific software applications to solve particular biological problems. The broader impact/commercial potential of this project is to enable life scientists with a new and powerful instrument for studying live cells. The greatest impact of the commercial instrument developed in Phase II project will have is enabling researchers to do science better than before, i.e., more accurately, more quantitatively, and more noninvasively. The range of breakthroughs enabled by the instrument will likely include: novel drug discovery by accurate monitoring of cell response to treatment, fundamental studies of cell proliferation and growth, minimally invasive automatic diagnosis of cancer biopsies, and fast and accurate blood testing instruments. Scaling up the production of the instrument will create new jobs and increase the US dominance in the biotechnology area. Due to their full automation, the instruments can also operate in areas with limited access to trained personnel and provide the digital data necessary for remote diagnosis, such as Medically Underserved Areas/Populations in United States.