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). Timely diagnosis and treatment of BSIs has been demonstrated to improve patient outcomes and reduce hospitalization time. However, currently accepted diagnostic approaches still require primary blood cultures, which are not only slow, requiring ~1-3 days, but also demonstrate reduced sensitivity in the presence of antimicrobial treatment. There is thus a significant need for new diagnostic approaches that do not require cultures and provide faster, more accurate results. To address this unmet need, HelixBind developed RaPID (Resistance and Pathogen IDentification), a fully automated, sample-to-answer platform appropriate for placement throughout the hospital. RaPID consists of a bench-top Analyzer operating single-use cassettes capable of identifying and characterizing complex invasive infections directly from patient specimens, without cultures. Being culture-free, RaPID tests are not inhibited by polymicrobial infections nor prior antimicrobial treatment. The first test implemented on this platform, RaPID/BSI, incorporates a broad test menu of 21 bacterial and fungal pathogens with single CFUs/ml sensitivity within roughly 3 hours. Over multiple clinical studies the test has demonstrated >94% sensitivity and >99% specificity relative to culture across the test menu. Owing to the product's advantages over exiting alternatives and its potential to improve care, the FDA designated RaPID/BSI a Breakthrough Technology in 2020. HelixBind has recently completed proof-of-concept studies of a reflex test to complement RaPID/BSI which targets the most common and clinically relevant antimicrobial resistance genes found in BSIs. This test, RaPID/R, has not only demonstrated single CFUs/ml sensitivity across the panel of resistance genes, but also the ability to properly characterize multiple drug resistant (MDR) microorganisms. A manual version of the has been used to successfully detect resistance in clinical samples. In this proposed Phase II project, HelixBind will translate the test to the automated RaPID platform. Studies demonstrating analytical sensitivity and specificity will be completed as will a blinded clinical assessment of RaPID/R. These studies will ensure that product performance matches specifications and clinical requirements. In parallel, study designs for product verification and validation will be completed and submitted to the FDA as part of a Pre-Submission process. To succeed in this project, we have assembled an accomplished team with expertise in assay development, instrumentation, consumables manufacturing, regulatory compliance, clinical microbiology, and infectious disease. This team has a successful track record of commercializing FDA-cleared IVD platforms and assays. Together, we will build upon our preliminary work to complete product development. Upon completion of this project, we will be well placed to initiate formal Analytical and Clinical studies required for FDA clearance.
Public Health Relevance Statement: PROJECT NARRATIVE Sepsis, the body's response to a bloodstream infection, is often life-threatening. Timely administration of appropriate antimicrobials is critical for successfully patient outcomes. However, current diagnostics for identifying and characterizing the infection, necessary for selection of the appropriate antimicrobial, rely on blood culture and require several days to provide results. As a consequence, physicians have to rely on empirical treatment with broad spectrum antibiotics, which may be ineffective to the patient's infection, exposes patients to the risk of complications, and exemplifies poor antibiotic stewardship. The efforts described in this proposed Phase II program will advance the maturity of a novel, fully automated test capable of characterizing clinically important resistance mechanisms in bloodstream infections in only a few hours and without cultures. Success in this effort will result in a diagnostic device addressing a significant unmet need, ready for transfer to manufacturing and verification & validation for FDA clearance and market launch.
Project Terms: Antibiotics; Antibiotic Agents; Antibiotic Drugs; Miscellaneous Antibiotic; Bacteremia; bacteraemia; bacterial sepsis; Biological Assay; Assay; Bioassay; Biologic Assays; Blood; Blood Reticuloendothelial System; Budgets; Clinical Research; Clinical Study; Communicable Diseases; Infectious Disease Pathway; Infectious Diseases; Infectious Disorder; Complement; Complement Proteins; Cessation of life; Death; Diagnosis; Engineering; Hospitalization; Hospital Admission; Hospitals; University Hospitals; Infection; instrumentation; Laboratories; Lead; Pb element; heavy metal Pb; heavy metal lead; Manuals; Methods; mortality; Patients; Physicians; Play; Reflex; Reflex action; Study Type; study design; Research Design; Risk; social role; Role; Sensitivity and Specificity; Blood Poisoning; septicaemia; septicemic; Septicemia; Specificity; Technology; Temperature; Testing; Time; Translating; Work; Antibiotic Resistance; Resistance to antibiotics; Resistant to antibiotics; antibiotic drug resistance; antibiotic resistant; TimeLine; Blinded; Caring; base; Blood specimen; Blood Sample; improved; Clinical; Phase; Ensure; Multidrug Resistance; Multiple Drug Resistance; Multiple Drug Resistant; Resistance to Multi-drug; Resistance to Multidrug; Resistance to Multiple Drug; Resistant to Multiple Drug; Resistant to multi-drug; Resistant to multidrug; multi-drug resistant; multidrug resistant; Multi-Drug Resistance; fluid; liquid; Liquid substance; instrument; Diagnostic; Research Specimen; Specimen; Whole Blood; Life; programs; Adopted; Hour; Complex; Clinic; Diagnostic Device; Diagnostic Equipment; Medical center; experience; Performance; success; microbial; novel; member; Devices; Sampling; response; assay development; cross reactivity; Clinical Microbiology; Address; Health system; Antimicrobial resistant; Resistance to antimicrobial; anti-microbial resistance; anti-microbial resistant; resistance to anti-microbial; resistant to anti-microbial; resistant to antimicrobial; Antimicrobial Resistance; Detection; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; Preparation; Molecular; Process; resistance mechanism; resistant mechanism; Development; developmental; cost; design; designing; drug resistant microorganism; drug resistant microbes; drug-resistant microbes; Sepsis; blood infection; bloodstream infection; Clinical assessments; pathogen; pathogenic bacteria; bacteria pathogen; bacterial pathogen; Resistance; resistant; antimicrobial; anti-microbial; clinically relevant; clinical relevance; novel diagnostics; new diagnostics; next generation diagnostics; service utilization; product development; verification and validation; resistance gene; resistance locus; resistant gene; pathogenic fungus; fungal pathogen; fungi pathogen; systemic inflammatory response; systemic inflammation; rapid test; rapid assay; rapid tests; patient prognosis; diagnostic strategy; diagnostic approach
