Phase I Amount
$1,050,000
Leading to over 270, 000 deaths in the US annually, septicemia is the systemic inflammatory response to a bloodstream infection (BSI). Early diagnosis and treatment of BSIs have demonstrated improved patient outcomes and reduced hospitalization time. However, currently accepted diagnostic approaches require a blood culturing step, which is not only slow, but also demonstrates reduced sensitivity in the presence of antimicrobial treatment. Current techniques are therefore considered unreliable for monitoring effectiveness of treatment once begun. There is a significant need for new diagnostic approaches for BSIs that are culture-free and provide microbiological information throughout the course of care. To address this unmet need, HelixBind will leverage the capabilities of its proprietary direct-from-specimen (i.e., culture-free) platform, RaPID (Resistance and Pathogen IDentification) to assess the microbial load of an infection in response to an antimicrobial intervention. RaPID/BSI, the first test for this system, detects and identifies BSIs directly from patient whole-blood within 3 hours. Incorporating a broad test menu with single CFUs/ml sensitivity, the test is not confounded by polymicrobial infections nor antimicrobial treatment. Across multiple clinical studies, the assay has demonstrated >95% sensitivity and >99.8% per assay specificity. RaPID/BSI was designated as a Breakthrough Device by the FDA. As a result of this program, the capability to accurately assess microbial load will be added RaPID/BSI. With this capability in place, initial test results will provide clinicians with pathogen identification along with a measure of load; a marker for infection severity. Combined, this information will assist clinicians in source control and selecting the most appropriate antimicrobial intervention. Follow-up measurements will then allow the clinician to gauge for microbial clearance, a requisite for patient recovery. Beyond the immediate, patient-specific impact, this program will directly support improved antimicrobial stewardship as required to combat the rise of antimicrobial resistance pathogens. Our Specific Aims, each with quantifiable deliverables, are designed to complete all technical development, systems verification, stress testing, and clinical validation in collaboration with our clinical partners. The focus of this study will be to validate the capability of our innovative approach, setting the stage for further work aimed at optimizing its implementation in the clinical setting. In achieving our Specific Aims, we will have developed and demonstrated, a revolutionary approach towards identifying, characterizing, monitoring, and treating invasive infections of the bloodstream.
Public Health Relevance Statement: PROJECT NARRATIVE Rapid and accurate detection, identification, and characterization of invasive bloodstream infections is one of the most urgent unmet clinical needs today, where timely initiation of the appropriate antimicrobial is one of the key determinants of patient outcome. The current standard of care is too slow, is known to miss certain infections and cannot be used to track progression of the infection. In this program, HelixBind will leverage its RaPID platform and RaPID/BSI to develop the first diagnostic test capable of not only identifying these infections direct from blood, but also assessing the microbial load while monitoring progress towards clearance in response to the antimicrobial intervention. The information provided would enable the clinician to personalize the antimicrobial for optimal outcomes, ensure progress is being made towards recovery, while improving antimicrobial stewardship.
Project Terms: Biological Assay; Assay; Bioassay; Biologic Assays; Blood; Blood Reticuloendothelial System; Budgets; Clinical Research; Clinical Study; Combined Modality Therapy; Multimodal Therapy; Multimodal Treatment; combination therapy; combined modality treatment; combined treatment; multi-modal therapy; multi-modal treatment; Cessation of life; Death; Exhibits; Hospitalization; Hospital Admission; Hospitals; Infection; Lead; Pb element; heavy metal Pb; heavy metal lead; Leadership; Methods; Patients; Research Design; Study Type; study design; Septicemia; Blood Poisoning; septicaemia; septicemic; Specificity; Technology; Testing; Time; Work; Measures; Diagnostic tests; Treatment Effectiveness; timeline; Blinded; Caring; Blood Sample; Blood specimen; improved; Clinical; biologic; Biological; Ensure; Recovery; Measurement; Collaborations; Diagnostic; Specimen; Research Specimen; Whole Blood; programs; Viral Load result; Viral Burden; Viral Load; Hour; Severities; Source; Techniques; System; Test Result; Viral; interest; Medical center; Early Diagnosis; early detection; Performance; success; microbial; member; validation studies; Molecular Diagnostic Testing; molecular diagnostic assays; Sampling; response; Intervention; Intervention Strategies; interventional strategy; Address; Dose; Antimicrobial Resistance; Antimicrobial resistant; Resistance to antimicrobial; anti-microbial resistance; anti-microbial resistant; resistance to anti-microbial; resistant to anti-microbial; resistant to antimicrobial; Detection; National Institute of Allergy and Infectious Disease; NIAID; in vivo; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; patient oriented outcomes; Validation; validations; Monitor; Preparation; preparations; follow-up; Active Follow-up; active followup; follow up; followed up; followup; Development; developmental; cost; designing; design; blood infection; bloodstream infection; Sepsis; clinical site; clinical research site; Outcome; pathogen; bacteria pathogen; bacterial pathogen; pathogenic bacteria; Stress Tests; innovate; innovative; innovation; resistant; Resistance; anti-microbial; antimicrobial; early therapy; Early treatment; new diagnostics; next generation diagnostics; novel diagnostics; commercialization; combat; patient population; standard of care; Assessment instrument; Assessment tool; optimal therapies; optimal treatments; fungal pathogen; fungi pathogen; pathogenic fungus; systemic inflammation; systemic inflammatory response; diagnostic strategy; diagnostic approach; diagnostic tool; Breakthrough device
