Rapid, accurate and user-friendly clinical surge-testing for biothreat agents

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DESCRIPTION (provided by applicant): Following a major bioterrorism attack or infectious disease outbreak, millions of potential victims may require rapid testing to ensure delivery of life-saving therapeutic treatment to those who need it. Because today there is no diagnostic method capable of high-performance large-scale testing in a crisis situation, thousands could die needlessly due to inefficient targeting of precious medical resources. We are developing the MultiPathTM Surge Testing Platform, the first high-performance high-throughput system designed for on-site clinical surge testing. The MultiPath system is an ideal surge-testing platform, being rapid, high throughput, sensitive, quantitative, accurate, cost-effective, user-friendly, portable, and automated. It accommodates tests for a broad menu of biothreat or infectious disease agents including bacteria, fungi, viruses, and toxins. While as sensitive as high performance central laboratory tests, the MultiPath assays are as rapid and as easy-to-use as over-the-counter rapid tests and require no sample preparation. The proprietary MultiPath immunoassay technology achieves high sensitivity and quantification by using digital imaging to count target molecules tagged with fluorescent particles without using magnification. The MultiPath assay design eliminates wash steps, reducing engineering complexity and cost while increasing throughput. Under a Phase II SBIR we designed and integrated a fully functional prototype of the MultiPath Surge Testing Platform and a sensitive surge test for anthrax. Our data demonstrate that the MultiPath Anthrax test rapidly (6 min) and sensitively (low pg/ml) detects two anthrax markers with high accuracy (internal positive and negative control assays are included for each marker) and specificity in small whole blood fingerstick samples with no sample prep. The prototype MultiPath platform automatically performs 600 assays/hour and integrates automated liquid handling, sample tracking, data analysis, and report generation. We propose to develop the commercial MultiPath Surge Testing Platform and MultiPath Anthrax Test. Specifically, we propose to (1) develop commercial quality particle-based immunoreagents for the ultra-sensitive MultiPath Anthrax test, (2) develop manufacturing procedures for large scale production of reagents that can be stored long-term at room temperature, (3) develop the commercial MultiPath Surge Testing Platform, (4) integrate the MultiPath Surge Testing Platform and MultiPath Anthrax test, and (5) verify the efficacy of the platform and anthrax test. To supplement our core expertise in developing MultiPath platform and assays, we will leverage the expertise of academic, industry, and government collaborators. On completion of the proposed project we will begin validation of the platform and anthrax test for subsequent regulatory submission. We propose to deploy the surge-testing platform and reagents to test for a menu of biothreat and disease outbreak agents at key points in the public health system - including the Strategic National Stockpile, state and city public health institutions, and the Laboratory Response Network. PUBLIC HEALTH RELEVANCE: Following a major bioterrorism attack or infectious disease outbreak, millions of potential victims may require rapid and efficient testing to ensure delivery of life-saving therapeutic treatment to those who need it. Because today there is no diagnostic method capable of high-performance large-scale testing in a crisis situation, thousands could die needlessly due to inefficient targeting of precious medical resources. To address the critical gap in the nation's public health preparedness for large-scale surge testing we propose to develop the MultiPath Surge Testing Platform and the MultiPath Anthrax Test.