SBIR-STTR Award

The bioterrorism attacks of 2001 highlighted the acute need for rapid, ultra-sensitive, cost-effective, and user-friendly tests to simultaneously screen for multiple types of biowarfare agents at the point of exposure. The goal of the proposed project is to demonstrate the potential of the MultiPath TM test to meet this important need. The MultiPath TM test is designed to rapidly detect multiple disparate agents with the ultra-sensitivity of a nucleic acid amplification test but with the cost-effectiveness and user-friendliness of over-the-counter immunoassay "strip" tests. The test's novel capabilities arise from melding a unique combination of proprietary and existing technologies. The MultiPath TM test uses high-intensity target-specific HiLiter TM microbead labels which produce a signal so intense that individual microscopic beads are easily detected by visual inspection of exposed instant film. The labeling and detection strategy enhances cost-effectiveness and portability by eliminating the need for a light source, imaging optics, photodetectors, and the supporting electrical power sources. Preliminary work described in this proposal indicates the feasibility of key elements of this approach. The proposed project will demonstrate the feasibility of the MultiPath TM test using three model targets (a bacterium, virus, and protein) that emulate the spectrum of targets that might be used in biowarfare. The Specific Aims of the proposal are to (1) demonstrate the use of high-intensity HiLiter TM microbeads for the three model targets; (2) demonstrate the efficacy of a fluidics system that is novel and powerful, yet simple and inexpensive; (3) demonstrate the feasibility of the MultiPath TM test imaging system comprising an instant film detection unit, a scanner, and imaging software; and (4) demonstrate the feasibility of integrating this system to scan samples containing low levels of targets. The Phase 1 results, besides demonstrating the feasibility of the MultiPath TM test, will support the Phase 2 goals which are to develop a MultiPath TM test prototype and show its efficacy in comparisons to "gold standard" tests in the context of "real world" samples. Competitive advantages of the MultiPath TM test include the intellectual property covering key features of the test, an unprecedented feature list of high-end results and customer-friendly attributes, and straightforward commercialization path. Besides addressing the large and growing bioterrorism market, the MultiPath TM test addresses significant unmet testing needs in healthcare (infectious disease, cancer, cardiovascular disease) and in industrial microbiology (food, beverage, pharmaceutical manufacturing). The value that the MultiPath TM test will bring to both the primary and secondary markets is expected to attract large corporations as partners to support commercial development, marketing, and distribution.

Thesaurus Terms:
biohazard detection, biomedical equipment development, bioterrorism /chemical warfare, image processing, imaging /visualization /scanning, luminescence, portable biomedical equipment Escherichia coli 0157:H7, fluid flow, influenzavirus A, interleukin 2, microcapsule bioimaging /biomedical imaging

Following a bioterrorist attack, hundreds of thousands of potential victims may require testing and treatment. The critical need to test large numbers of people for exposure to a biothreat agent may overwhelm the capacity of the clinical and public health infrastructure. The approximately 25,000 sentinel laboratories in the Laboratory Response Network, which coordinates preparedness and response, need diagnostic tools to enable accurate decentralized testing. The goal of the proposed project is to develop a surge-testing platform for this network. The 2001 anthrax attacks showed that administering aggressive therapy to victims who have early diagnostic evidence of blood infections saves lives. Specifically, we will address the need for identifying patients that require aggressive life-saving therapy by developing a blood test for B. anthracis infection that tests for multiple-toxin and cellular antigens using the MultiPath(tm) testing system which we demonstrated in Phase I. The MultiPath system is an ideal surge-testing platform, being ultra-sensitive, quantitative, accurate, cost-effective, user-friendly, portable, and automated. The test rapidly detects multiple targets with sensitivities approaching nucleic acid amplification tests but with the cost-effectiveness and user-friendliness of over-the-counter immunoassay "strip" tests. In Phase I we showed that the MultiPath test detects protein, bacterial, and viral targets at levels up to thousands of times lower than commercial strip tests. This sensitivity comes from using a proprietary imaging approach which detects individual microparticles rather than the millions of particles required to detect a signal in standard strip tests. The system will comprise kits that acquire and automatically test blood samples rapidly (target assay time = 5 min) for sub-picogram levels of multiple B. anthracis antigens (to minimize false positives); an identification system to link patients to the test results; and a portable standalone near-patient test analyzer that will automatically process batch-loaded samples (<10 seconds per sample) and that will print and wirelessly post the results. The Specific Aims of the application are to (1) develop a prototype consumable kit containing an integrated consumable for collecting the sample and automatically running the assay; (2) develop the cost-effective batch-loadable near-patient analyzer; (3) integrate the system components; and (4) demonstrate the efficacy of the system to detect B. anthracis sensitively and specifically in whole blood samples. The Phase 2 project results and deliverables will support the Phase 3 commercialization goals for implementing the MultiPath B. anthracis test in the public health preparedness system. Follow-on products will include clinical tests for other potential biothreat and infectious agents and an instrument-free platform for detection of biothreat agents outside of the clinic. Competitive advantages of the MultiPath test include the intellectual property covering key features of the test, an unprecedented feature list of high-end results and customer-friendly attributes, and straightforward commercialization path. Besides addressing the large and growing bioterrorism market, the MultiPath test addresses significant unmet testing needs in healthcare (infectious disease, cancer, cardiovascular disease) and in industrial microbiology (food, beverage, pharmaceutical manufacturing). The value that the MultiPath test will bring to both the primary and secondary markets should attract large corporations as partners to support commercial development, marketing, and distribution.

Thesaurus Terms:
Bacillus anthracis, biohazard detection, blood test, diagnosis design /evaluation, diagnostic test, rapid diagnosis biomarker, consumable /disposable biomedical equipment, molecular /cellular imaging bioterrorism /chemical warfare, human tissue, laboratory mouse