This federal Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), is providing $781,129 to The Regents of the University of California, San Francisco (UCSF) to conduct a prospective, multicenter cohort study of 400 critically ill children with acute respiratory failure. The key objectives are to: 1) independently validate the performance of UCSF's existing integrated host/microbe...
This National Science Foundation (NSF) Small Business Innovation Research (SBIR) Phase I award to RT Microdx Inc. provides $274,362 to develop a novel molecular diagnostic platform for detecting respiratory diseases like strep throat. The platform aims to provide laboratory-level accuracy for home use by non-healthcare professionals, reducing the burden on healthcare facilities and improving access to rapid and reliable pathogen detection, especially in underserved areas. The project focuses...
This $1,052,276 Project Grant award from the National Heart, Lung, and Blood Institute (NHLBI), under the Cardiovascular Diseases Research program (CFDA 93.837), supports the development and validation of a wearable multimodal sensor system for remote monitoring of patients with chronic obstructive pulmonary disease (COPD). The project, titled "Bilateral Acoustic Sensing and Automated Breathing Segmentation for Remote Monitoring of Patients with COPD: A Longitudinal Study," aims to...
Precision Theranostics Inc. was awarded a $256,000 Small Business Innovation Research Phase I Project Grant by the National Science Foundation Division of Industrial Innovation. The grant supports the development of a lung health diagnostic test for chronic obstructive pulmonary disease and prognosis-based early intervention from May 1, 2021 to April 30, 2022. The grant falls under the National Science Foundation's Engineering program (CFDA 47.041), which seeks to improve quality of life and...
This Project Grant award from the National Heart, Lung, and Blood Institute (NHLBI), under the Cardiovascular Diseases Research federal grant program (CFDA 93.837), provides $301,224 to PGXL Technologies LLC to advance the development of a urine-based, multiplex immunoassay panel for screening children for obstructive sleep apnea (OSA). The goal is to create a rapid, non-invasive diagnostic tool that can improve OSA screening, diagnosis, and monitoring, which is currently limited by the high...
This $700,000 Project Grant awarded by the National Institute of General Medical Sciences (NIGMS) under the Biomedical Research and Research Training program (CFDA 93.859) supports the clinical validation of Prenosis, Inc.'s Immunix platform for precision medicine endotyping of sepsis patients. The project aims to: 1) validate Immunoscan immunoassays and generate mapping functions to Luminex immunoassays; 2) validate a parsimonious model for point-of-care endotyping; and 3) demonstrate the...
This Project Grant award from the National Cancer Institute (NCI), under the Cancer Detection and Diagnosis Research program (CFDA 93.394), is supporting the development of a high-sensitivity, high-specificity lung cancer subtyping diagnostic test by Orbit Genomics, Inc. The $1,999,108 award will enable Orbit Genomics to: 1) obtain patient blood samples with known lung cancer subtypes to train their diagnostic test, 2) upgrade their microsatellite allelotyping and AI-based classification...
This $788,406 project grant from the National Institutes of Health National Institute of Allergy and Infectious Diseases, under the Allergy and Infectious Diseases Research program (CFDA 93.855), will fund the development of a sensitive, direct reading bioaerosol detection platform to quantify airborne pathogens such as SARS-CoV-2. Aerosol Devices Inc. will integrate their gentle condensation-growth capture sampler, which concentrates intact, viable virus particles into a small liquid volume...
This Project Grant awarded by the National Heart, Lung, and Blood Institute (NHLBI) under the Cardiovascular Diseases Research federal grant program (CFDA 93.837) provides $480,990 to the University of Illinois to investigate the role of aerocytes, a specialized capillary endothelial cell population, in regulating alveolar epithelial regeneration following lung injury. The research aims to establish aerocytes as central regulators of alveolar regeneration, with a focus on the signaling...
This National Science Foundation (NSF) Technology, Innovation, and Partnerships (CFDA 47.084) Project Grant award supports the development of a novel device that can rapidly and automatically extract pathogen DNA from whole blood samples to enable faster diagnosis of sepsis. The $274,858 award to New England Hemolytics, Inc., with a project period from September 1, 2024 to February 28, 2025, will fund the testing and optimization of this technology across common sepsis-causing pathogens. The...
ENABLING COMPREHENSIVE DIAGNOSIS OF SUB-ACUTE INFECTION IN CHRONIC RESPIRATORY DISEASE VIA HIGH SENSITIVITY NEXT GENERATION SEQUENCING - ABSTRACT SUB-ACUTE LUNG INFECTIONS ARE INCREASINGLY RECOGNIZED AS DRIVERS OF POOR SYMPTOM CONTROL AMONG A SUBSET OF INDIVIDUALS WITH CHRONIC LUNG DISEASE, ESTIMATED TO BE MORE THAN 2 MILLION IN THE US FOR ASTHMA AND COPD PATIENTS. WHEN THESE SUB-ACUTE INFECTIONS ARE DIAGNOSED AND TREATED APPROPRIATELY, CHRONIC LUNG DISEASE PATIENTS CAN CONVERT FROM MODERATE/SEVERE TO A MILDER DISEASE PHENOTYPE, REQUIRING LOWER MEDICATION TO ACHIEVE BETTER HEALTH AT A SIGNIFICANTLY LOWER COST. CURRENT GOLD-STANDARD DIAGNOSTICS FOR SUB-ACUTE INFECTION RELY ON DECADES-OLD TECHNOLOGY THAT CAN TAKE WEEKS TO COMPLETE, HAVE LIMITED SENSITIVITY, AND ARE LIMITED IN THE TYPE AND NUMBER OF MICROBES THAT CAN BE SCREENED BY A SINGLE TEST. THUS, A CRITICAL GAP EXISTS DUE TO THE INABILITY OF CURRENT DIAGNOSTICS TO COMPREHENSIVELY AND ACCURATELY DETECT MICROBIAL PATHOGENS IN LOW-BURDEN CLINICAL SAMPLES, WHICH IS A SIGNIFICANT BARRIER TO IMPROVED CLINICAL OUTCOMES IN CHRONIC LUNG DISEASE. WE HAVE THUS DEVELOPED A COMPREHENSIVE NEXT GENERATION SEQUENCING (NGS) PANEL FOR DETECTION AND IDENTIFICATION OF MICROBES. OUR PHASE I STUDIES HAVE DEMONSTRATED THE FEASIBILITY OF OUR DIAGNOSTIC TOOL FOR APPLICATION TO SUBCLINICAL RESPIRATORY INFECTIONS AND ITS SUPERIORITY TO BOTH MICROBIOLOGICAL AND MOLECULAR APPROACHES TO DIAGNOSIS. OUR NGS DIAGNOSTICS (DX) PANEL IS A SIGNIFICANT TECHNOLOGICAL INNOVATION OVER CURRENT METHODOLOGY; THE DX PANEL UTILIZES SAMPLES DIRECTLY FROM THE PATIENT (RATHER THAN RELYING ON CULTURES), PROVIDES GREATER SENSITIVITY THAN QPCR OR META-GENOMIC SEQUENCING APPROACHES AND SCREENS FOR THE PRESENCE OF TENS OF THOUSANDS OTHER MICROBES IN A SINGLE ASSAY. THESE FEATURES ARE POSSIBLE DUE TO OUR DX PANEL DESIGN IN ADDITION TO PROPRIETARY LABORATORY AND ANALYSIS WORKFLOWS. THE LONG-TERM GOAL OF THIS PROJECT IS TO PROVIDE NOVEL CLINICAL TOOLS FOR THE DETECTION OF LOW- BURDEN MICROBIAL INFECTIONS DRIVING DISEASE PATHOLOGY, SYMPTOMOLOGY, AND EXACERBATIONS IN CHRONIC LUNG DISEASE POPULATIONS. IN THIS PHASE II, WE WILL DEVELOP A DATA INTEGRATION SYSTEM TO 1) DEPLOY OUR DIAGNOSTIC TEST IN HEALTHCARE ORGANIZATIONS TO DRIVE PHYSICIAN ADOPTION, 2) BUILD DATA AND APPLY ALGORITHMS NECESSARY TO EXPAND THE IMPACT AND VALUE-BASED REIMBURSEMENT OF OUR ASSAY. OUR AIMS ARE TO 1) DEVELOP A CLOUD-BASED COMMERCIAL SOFTWARE SYSTEM FOR DATA RECEIPT, STORAGE, ANALYSIS AND CLINICAL REPORTING AT SCALE, 2) INTEGRATE OUR SOFTWARE SYSTEM INTO THE CLINICAL WORKFLOW AT OUR CLINICAL PARTNERS, AND 3) DEVELOP A WEB-BASED VISUALIZATION PORTAL FOR TEST RESULTS AND BUILD THE INFRASTRUCTURE FOR USE OF ADVANCED STATISTICAL LEARNING ALGORITHMS. THIS INTEGRATED SYSTEM WILL DRIVE THE DEVELOPMENT AND APPLICATION OF PERSONALIZED MEDICINE APPROACHES FOR DIAGNOSIS AND TREATMENT GUIDANCE CURRENTLY MISSING IN CHRONIC LUNG DISEASE. THE TOTAL MARKET FOR THIS DIAGNOSTIC IS THE SET OF CHRONIC LUNG DISEASE PATIENTS WITH UNCONTROLLED SYMPTOMS WHO COULD BE SCREENED FOR SUB-ACUTE INFECTIONS. OUR COMPETITIVE ADVANTAGES INCLUDE IMPROVED SENSITIVITY, COMPREHENSIVE MICROBE DETECTION, STREAMLINED ANALYSIS, AND TREATMENT EFFECTIVENESS INSIGHTS WITHIN A SINGLE ASSAY.