R44AI174578

Diagnostic Tool for Assessment and Tracking of Microbial Load in Bloodstream Infections - Project Summary

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 to 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.

Helixbind

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.855 - Allergy and Infectious Diseases Research

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Boxborough, Massachusetts 017192200 United States

Single Zip Code

PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) (PA-21-259)

Amendment Since initial award the total obligations have increased 189% from $1,050,000 to $3,031,639.