SBIR-STTR Award

This SBIR research effort is aimed at the development and testing of a novel system for blood analysis that utilizes MEMS fabricated chips and multiple, radio-frequency electric impedance interrogation signals to differentiate cell types. Our long-term goals for the project can be summarized as three: 1) develop an inexpensive CBC analysis system utilizing disposable MEMS-based micro-fluidic chips for physician's offices, 2) miniaturize the electronic hardware and develop a highly portable CBC analyzer utilizing the same core technologies and 3) expand on the basic technologies (by integrating additional cell detection methods) to enhance system capabilities, performance and reliability. As part of the proposed long-term effort, we will fabricate, characterize and commercialize the first generation MEMS mu-CBC Analyzer. To achieve this, the present SBIR proposal addresses miniaturization of the conductance and impedance base cell counting techniques by incorporating disposable, micro-fabricated detectors into relatively inexpensive bench-top analysis systems. The first of three aims will concentrate on designing and micro-fabricating the next generation MEMS flow-chips suitable for proof-of-concept cell counting studies using radio-frequency impedance measurements. The second aim will target the development for the micro-fluidics required to drive the blood through the micro-channel at a flow-rate suitable for single file interrogation of cells. Aim three will focus on additional proof-of-concept studies to demonstrate feasibility of this technology to function as a hematology analyzer. Future work will build upon the results of the present proposal to create a field portable mu-CBC Analyzer based on the same micro-fluidic cell counting chip. We envision these mu-El systems will eventually lead to the development and commercialization of highly portable systems capable of drastically improving the ease (and availability) of administering blood tests (4-6 years). For example, these systems will enable field tests for remote patients with HIV, rapid testing for incoming emergency room patients, and self-administered home blood testing. These future multiple-detector systems will become extremely cost and performance competitive with the state-of-the-art hematology analyzers (6-10 years). To our knowledge, there are no other commercial efforts to develop blood cell counting instrumentation using MEMS-based technology.

Thesaurus Terms:
biomedical equipment development, blood cell count, hematology, miniature biomedical equipment consumable /disposable biomedical equipment, electrical impedance, erythrocyte, fluid flow, leukocyte, monitoring device, platelet, portable biomedical equipment, radiowave radiation bioengineering /biomedical engineering, human tissue

This Phase II SBIR effort will research and test a novel system for blood analysis that utilizes micro-electro- mechanical systems (MEMS) fabricated chips and radio-frequency electric impedance (EI) interrogation signals to differentiate blood cell types. The project's long-term objective is to create an inexpensive handheld hematology analyzer with single-use disposable cartridges capable of performing a complete blood count (CBC) using a 12fL sample of whole blood. In pursuit of this long term objective, this Phase II SBIR focuses on successfully miniaturizing the necessary conductance and impedance-based cell counting technologies, design and testing of the single-use CBC microfluidic cartridges, as well as testing the supporting electronics and micro-fluidics interfaces for the proposed handheld system. The system will be powered by a programmable personal device assistant (PDA) for test control, data collection, analysis of raw EI cell data, and results display. Specifically, three aims will be pursued: (1) design and testing of a CBC disposable cartridge; (2) design and testing of the PDA driven electronics and analysis software; and (3) integration and performance testing of the CBC analyzer system components. If successful, the eventual introduction of such a groundbreaking point-of-care device would constitute a technological breakthrough in hematology and will offer health care providers a valuable alternative to the traditional hematology analyzers currently used in most clinical laboratories. Anticipated benefits from such a device include dramatically lower test costs, rapid test results, next-to-patient care & portability, and increased efficiency in diagnosis and treatment. This new point-of-care system has the potential to significantly reduce the CBC equipment and per-test cost and could result in millions of dollars saved in the US healthcare industry alone (2004 US CBC market estimated at $12 billion), with even greater worldwide cost savings potential. This new micro-fabricated platform technology and its first product application (i.e., a handheld CBC analyzer with disposable cartridges) is the only known commercial effort of its kind. The successful completion of an inexpensive, portable handheld hematology analyzer would constitute a significant breakthrough in hematology by offering healthcare providers a less expensive, simpler platform to conduct the most common blood diagnostic test currently performed in the US. Such a breakthrough will dramatically improve testing efficiencies with its single-use, disposable test cartridges and will make it possible to rapidly test patients at bedside, in remote locations, or in areas with limited healthcare resources. Finally, this new point-of-care system could significantly reduce current CBC equipment and per-test costs, thereby resulting in millions of dollars saved in the US healthcare and insurance industries (2004 US CBC market estimated at $12 billion), with even greater worldwide healthcare impacts in developing countries.

Thesaurus Terms:
Biomedical Equipment Development, Blood Cell Count, Hematology, Miniature Biomedical Equipment Computer Program /Software, Computer System Design /Evaluation, Consumable /Disposable Biomedical Equipment, Electrical Impedance, Erythrocyte, Leukocyte, Microfluidics, Monitoring Device, Platelet, Portable Biomedical Equipment, Radiowave Radiation Bioengineering /Biomedical Engineering, Human Tissue