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...
This National Science Foundation (NSF) Technology, Innovation, and Partnerships (CFDA 47.084) Phase I Small Business Innovation Research (SBIR) project grant, awarded to Anvil Diagnostics Inc. in the amount of $298,646, aims to develop a rapid diagnostic test for sepsis-causing pathogens in plasma samples using digital PCR hardware. The proposed technology seeks to comprehensively identify and quantify a panel of 17 common sepsis-causing pathogens within 4 hours from small blood volumes,...
The National Institute of Allergy and Infectious Diseases (NIAID) awarded a $473,937 Project Grant under the Allergy and Infectious Diseases Research Program (CFDA 93.855) to The General Hospital Corporation, doing business as Massachusetts General Hospital (MGH), to develop a novel point-of-care liquid biopsy for early detection of sepsis-associated organ damage. The project aims to optimize a microfluidic enrichment and digital PCR assay to detect tissue-derived circulating rare cells...
This $305,000 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 development of a clinical decision support system (CDSS) called Sepsis FLO. The CDSS is designed to precisely guide blood volume diagnosis and treatment for sepsis patients. Key activities include: 1) Developing an alpha prototype of the CDSS through user-centered design; 2) Validating three functional...
This Project Grant award of $412,250 from the National Heart, Lung, and Blood Institute (NHLBI) under the Cardiovascular Diseases Research program (CFDA 93.837) will fund the development of a continuous, real-time, automated smart catheter analyzer to enable early identification of sepsis through urine biomarkers. The primary goal is to create a device that can quickly diagnose sepsis, a life-threatening condition, without requiring invasive blood tests. The 2-year R61 (Phase I) project will...
This $700,000 Project Grant award from the National Institute of General Medical Sciences (NIGMS) Biomedical Research and Research Training Program (CFDA 93.859) supports the clinical validation of Prenosis, Inc.'s IMMUNIX platform, a precision medicine endotyping solution for sepsis. The project aims to: 1) validate the IMMUNOSCAN multiplex rapid test and mapping functions to Luminex immunoassays; 2) validate a parsimonious model for point-of-care endotyping; and 3) demonstrate the ability to...
This Project Grant award of $305,000.00 from the National Science Foundation (NSF) under the NSF Technology, Innovation, and Partnerships (CFDA 47.084) program supports the development of a rapid point-of-care antimicrobial susceptibility testing (AST) kit. The goal is to create a microfluidic-based platform that can provide actionable AST results within 6-9 hours, compared to the current 3-5 day turnaround, to help physicians prescribe the optimal antibiotic dosage sooner. This will reduce...
This Project Grant award from the National Science Foundation (NSF) under the Technology, Innovation, and Partnerships (CFDA 47.084) program provides $305,000 to Resonantia Diagnostics, Inc. to develop a rapid diagnostic platform for identifying pathogens and determining antimicrobial susceptibility within 60 minutes. The project aims to advance an acoustic sensor-based technology that can accurately detect pathogens at low concentrations and test their susceptibility to a diverse range of...
This $294,244 Project Grant award, funded by the Department of Health and Human Services (DHHS) Agency for Healthcare Research and Quality (AHRQ) under the Research on Healthcare Costs, Quality and Outcomes (CFDA 93.226) program, supports research to identify sepsis phenotypes associated with antibiotic-resistant pathogens. The project aims to leverage machine learning techniques, including large language models applied to clinical notes, to augment electronic health record (EHR) data and define...
This Project Grant award of $3,055,197.00 from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855) supports the development and evaluation of a rapid, low-cost phenotypic test for the detection of carbapenemase-producing organisms (CPOs). The objective is to create a structurally-programmed sticker microfluidic test that can provide rapid, objective carbapenemase detection and distinguish between carbapenemase...
CULTURE AND AMPLIFICATION-FREE BACTERIAL SEPSIS DIAGNOSIS - CULTURE AND AMPLIFICATION-FREE BACTERIAL SEPSIS DIAGNOSIS SUMMARY SEPSIS IS A LIFE-THREATENING COMPLICATION OF AN INFECTION THAT REQUIRES IMMEDIATE TREATMENT. THE IDENTIFICATION OF THE CAUSATIVE MICROORGANISM UTILIZING PROCESSES BASED ON BLOOD CULTURE IS A KEYSTONE OF SEPSIS DIAGNOSIS. HOWEVER, BLOOD CULTURE TAKES ONE TO FIVE DAYS TO PROVIDE RESULTS. HERE, WE PROPOSE THE DEVELOPMENT OF A CULTURE AND AMPLIFICATION-FREE ASSAY TO DETECT AND IDENTIFY BACTERIA IN ONE HOUR DIRECTLY ON WHOLE BLOOD. THE NEW ASSAY WILL ENABLE PHYSICIANS TO PROVIDE THERAPY TARGETING THE CAUSATIVE ORGANISM DAYS EARLIER THAN THE CURRENT STANDARDS. THE NEW ASSAY WILL BE BASED ON SINGLE MOLECULE TETHERING (SMOLT), A NOVEL SAMPLE PREPARATION AND AMPLIFICATION-FREE MOLECULAR DETECTION METHOD DEVELOPED AT SCANOGEN. THE WORK PROPOSED IN THIS APPLICATION WILL BUILD ON THE ACHIEVEMENTS OF AN ONGOING PROJECT AIMED AT DEVELOPING AN ASSAY TO DETECT FUNGI IN WHOLE BLOOD. THE SMOLT-BACTERIA ASSAY PROPOSED IN THIS APPLICATION WILL IDENTIFY THE SPECIES, GENUS OR ORDER OF THE CAUSATIVE ORGANISM IN APPROXIMATELY 90% OF BLOODSTREAM INFECTIONS. THE NEW SYSTEM WILL BE EASY-TO-USE, FULLY AUTOMATED, AND CAPABLE OF RAPID DETECTION IN WHOLE BLOOD WITHOUT BLOOD CULTURE. DESPITE THE URGENT CLINICAL NEED, THERE IS ONLY ONE FDA APPROVED CULTURE-FREE MOLECULAR ASSAY FOR SEPSIS DIAGNOSIS. IN COMPARISON TO THIS TEST, THE SMOLT- BACTERIA ASSAY WILL BE 4 TIMES FASTER, 6 TIMES LESS EXPENSIVE, AND THANKS TO ITS HIGHER MULTIPLEXING CAPABILITY, IT WILL DETECT AND IDENTIFY THE CAUSATIVE PATHOGEN IN TWICE THE NUMBER OF PATIENTS. IN OUR PRELIMINARY RESULTS, WE DEVELOPED A MULTIPLEX ASSAY CAPABLE OF DETECTING BACTERIA DIRECTLY IN WHOLE BLOOD. WE DEMONSTRATED THAT THE ASSAY IS HIGHLY SPECIFIC AND SENSITIVE WITH A LIMIT OF DETECTION (LOD) BETWEEN 1-10 CFU/ML, DEPENDING ON THE SPECIES, WHICH IS AS GOOD AS THE ONLY FDA-APPROVED TEST. IN THIS PROJECT, WE WILL COMPLETE THE DEVELOPMENT OF THE ASSAY PROTOCOL BY INCLUDING NEW PROBES AND OPTIMIZING THE OVERALL ASSAY (AIM 1). WE WILL TEST THE MANUAL PROTOCOL AND DEVELOP A FULLY INTEGRATED DISPOSABLE CARTRIDGE AND INSTRUMENT (AIM 2). FINALLY, WE WILL EVALUATE THE ASSAY IN PILOT ANALYTICAL AND CLINICAL VALIDATION STUDIES (AIM 3). WE WILL WORK WITH A MULTIDISCIPLINARY TEAM THAT INCLUDES EXPERTS IN ASSAY DEVELOPMENT AND INSTRUMENT DEVELOPMENT, INCLUDING THE FORMER VICE PRESIDENT OF ENGINEERING AT BECTON DICKINSON, EXPERTS IN MICROBIOLOGY, SEPSIS DIAGNOSIS AND TREATMENT FROM JOHNS HOPKINS UNIVERSITY AND THE UNIVERSITY OF PITTSBURGH, AS WELL AS ENGINEERS FROM KEY TECHNOLOGIES. AFTER COMPLETING THIS PROJECT, WE WILL FURTHER OPTIMIZE THE SYSTEM FOR USABILITY AND MANUFACTURABILITY AND CONDUCT ANALYTICAL AND CLINICAL STUDIES FOR SUBMISSION TO THE FOOD AND DRUG ADMINISTRATION (FDA). IF SUCCESSFUL, THE NEW AUTOMATED ASSAY CAN BECOME PART OF THE STANDARD PROCEDURE FOR THE DIAGNOSIS OF PATIENTS WITH SEPSIS AND IMPROVE PATIENTS' OUTCOMES BY DRAMATICALLY REDUCING THE TIME TO TARGETED ANTIMICROBIAL THERAPY.