The National Institute of Allergy and Infectious Diseases (NIAID), through the Allergy and Infectious Diseases Research program (CFDA 93.855), awarded a $300,000 Project Grant to Baebies, Inc. to develop a rapid, point-of-care diagnostic test to identify viable sexually transmitted infections (STIs). The objective is to create a panel of novel STI viability PCR (V-PCR) assays that can differentiate active infections from resolved or non-viable infections, enabling clinicians to diagnose and...
This National Science Foundation (NSF) Technology, Innovation, and Partnerships (CFDA 47.084) Project Grant award of $275,000 to Quarksen LLC provides funding to develop an affordable, point-of-care diagnostic device for detecting viral and non-viral sexually transmitted infections (STIs) such as chlamydia, gonorrhea, syphilis, HIV, hepatitis C, and trichomoniasis. The project aims to create a device with an array of sensors that can rapidly and accurately detect STI biomarkers from cervical...
The National Institute of Allergy and Infectious Diseases (NIAID) awarded Sherlock Biosciences, Inc. a $429,244 Project Grant under the Allergy and Infectious Diseases Research program (CFDA 93.855) to develop a power-free, molecular diagnostic device capable of detecting Chlamydia trachomatis and Neisseria gonorrhoeae from self-collected vaginal swabs. The project aims to create an accurate, easy-to-use, and inexpensive diagnostic that can be deployed for at-home screening, thereby improving...
This $233,250 Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855) aims to develop rapid point-of-care assays for detecting antibiotic resistance in the bacteria that causes syphilis, Treponema pallidum. The key products to be delivered under this 2-year grant include: A multiplexed, point-of-care loop-mediated isothermal amplification (LAMP) assay to detect single nucleotide...
This Project Grant award, provided by the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855), aims to address the growing syphilis epidemic and prevent congenital syphilis infections. The $212,357 project, to be completed by July 2026, has three key objectives: Develop a point-of-care nucleic acid test (POC NAT) on a microfluidic rapid and autonomous analytical device (MicroRAAD) with a colorimetric readout for...
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 Project Grant award 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 pilot implementation of a low-cost, point-of-care diagnostic assay for detecting Neisseria gonorrhoeae and molecular markers of antimicrobial resistance in resource-limited settings. The $195,480 award to Brigham & Women's Hospital, a subsidiary of Partners Healthcare System Incorporated, will...
This Cooperative Agreement award from the National Science Foundation (NSF) Technology, Innovation, and Partnerships (TIP) program (CFDA 47.084) provides $1,250,000 in funding to Prompt Diagnostics, Inc. to develop an automated, point-of-care diagnostic platform for detecting infections caused by Treponema pallidum, the bacterium that causes syphilis. The platform will combine rapid plasma reagin (RPR) and antibody tests into a multiplexed cartridge, enabling comprehensive diagnosis within...
The National Institute of Allergy and Infectious Diseases (NIAID) awarded a $299,170 Project Grant under the Allergy and Infectious Diseases Research program (CFDA 93.855) to Latde Diagnostics Corp., a woman-owned small business, to demonstrate the feasibility of a rapid, equitable antibiotic susceptibility test (AST) for urinary tract infections (UTIs). The goal of this Phase I project is to develop a metabolic amino acid phenotyping (MAAP) test kit that can provide susceptibility profiles...
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), provides $466,500.00 to support the development of a rapid and ultrasensitive aptamer-based detection technology for Treponema pallidum, the causative agent of syphilis. The goal is to create an inexpensive, point-of-care diagnostic test that can accurately diagnose syphilis in both adults and congenital cases, enabling...
STI NG PLUS, A SWAB TO ANSWER MOLECULAR PANEL TEST FOR POINT OF CARE DIAGNOSIS AND TREATMENT RECOMMENDATION - ABSTRACT THE NEED TO DEVELOP SENSITIVE, SPECIFIC, AND MORE EASILY AVAILABLE POINT-OF-CARE TECHNOLOGIES FOR DIAGNOSING STIS IS CRITICAL. MANY COUNTRIES, INCLUDING THE US, HAVE SEEN A SHARP INCREASE IN THE INCIDENCE OF STIS OVER THE PAST HALF-DECADE, AND ESPECIALLY SINCE 2020. MANY CASES GO UNDIAGNOSED AND UNTREATED, AND 30% OF PATIENTS MAY NEVER GET TREATMENT AFTER TESTING POSITIVE. SOME OF THESE STIS HAVE THE POTENTIAL TO CAUSE SERIOUS HEALTH PROBLEMS, INCLUDING INFERTILITY, ESPECIALLY IF NOT DIAGNOSED AND TREATED EARLY. STIGMA, PRIVACY, AND CONFIDENTIALITY ISSUES MAKE STIS OPTIMAL AREAS FOR POC TESTS AT HEALTHCARE FACILITIES, AS THEY CAN REDUCE LOSS TO FOLLOW-UP, INCREASE PATIENT AND PARTNER TREATMENT RATES, AND AVOID THE USE OF UNNECESSARY ANTIBIOTIC TREATMENT. THE COMPANY HAS DEVELOPED A MOLECULAR POINT OF CARE PLATFORM, THE AMPLIFIDXTM DX-1000, WHICH IS CAPABLE OF RAPID, MOLECULAR TESTING USING DIRECT SWABS AS THE SAMPLE TYPE. THE SYSTEM HAS FIVE OPTICAL CHANNELS, ALLOWING DETECTION OF UP TO 4 INFECTIOUS TARGETS PLUS AN INTERNAL CONTROL. THE DX-1000 IS DIFFERENTIATED AND WELL-SUITED FOR THE INFECTIOUS DISEASE TESTING MARKET. THE CHEMISTRY IS MULTIPLEXED AND SENSITIVE, YET SIMPLE, ALLOWING FOR A MINIATURIZED PRODUCT THAT WILL BE ATTRACTIVE IN THE POINT-OF-CARE SPACE. THE WORKFLOW IS EASY - ONE-STEP, SWAB TO ANSWER - AND DOES NOT REQUIRE COMPLEX MIXING OF REAGENTS OR HANDLING OF MULTIPLE STAGES OF THE PROCESS. LAB- QUALITY RESULTS WILL BE DELIVERS IN AS LITTLE AS 30 MINUTES FOR COVID-19. 20 MINUTES ARE POSSIBLE FOR DNA PARAMETERS AS THE NUMBER OF ASSAY STEPS CAN BE LESS. THE SLEEK CARTRIDGE AND INSTRUMENT ARE DESIGNED FOR LOW- COST MANUFACTURING. AMPLIFIDX IS POISED TO SUBMIT A FIRST EMERGENCY USE AUTHORIZATION (EUA) TO THE FDA FOR A COVID-19 DIAGNOSTIC, WHICH IS THE BASIS FOR THE PROPOSED ASSAY FOR STIS AND RELEVANT RESISTANCE MARKERS. WE PROPOSE THE DEVELOPMENT OF AN ASSAY WHICH WILL DETECT CHLAMYDIA TRACHOMATIS (CT) AND NEISSERIA GONORRHEA (NG), AS WELL AS MUTATIONS ASSOCIATED WITH ANTIBIOTIC RESISTANCE OR SUSCEPTIBILITY IN NG. WE ALSO PROPOSE THE DEVELOPMENT OF A URINE COLLECTION DEVICE THAT FITS EASILY IN TO THE EXISTING WORKFLOW, TO GIVE DOCTORS THE CHOICE OF ANOTHER SAMPLE TYPE. THIS ASSAY, WHICH WILL BE USED WITH UROGENITAL SWABS OR URINE SAMPLES ON THE DX-1000 DEVICE AND CARTRIDGE, WILL PROVIDE QUICK, ACTIONABLE DIAGNOSIS FOR CT AND NG AT POINT OF CARE, AS WELL AS GUIDING TREATMENT DECISIONS AND PROMOTING ANTIBIOTIC STEWARDSHIP BY IDENTIFYING ANTIBIOTIC-RELATED MUTATIONS.