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Isothermal Chain Reaction (ICR) Rapid and Early Detection of Pathogens for Sepsis Pont-of-Care Testing, Stratification, and Monitoring

Award Number: R43AI126956
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2016
PERIOD OF PERFORMANCE END DATE: 06/30/2019

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Isothermal Chain Reaction (ICR) Rapid and Early Detection of Pathogens for Sepsis Pont-of-Care Testing, Stratification, and Monitoring - Project Summary Objectives: The long-term objective of this application is to develop novel products for routine point-of-care (POC) genetic testing, ranging from pathogen identification to early cancer detection by using an innovative biotechnology called, Isothermal Chain Reaction (ICR). ICR is a disruptive and enabling technology platform that will offer a new class of reagents relevant to biomedical research and medical healthcare. ICR does not require any enzymes, primers, nucleotides, master mixes, extension reactions, cDNA intermediates, or thermocycling. These benefits overcome constraints of PCR-based technologies by being resistant to enzyme inhibitors found in laboratory samples and clinical specimens, having higher specificity for rare mutations, and lowering reagent costs. ICR is anticipated to enable selective, rapid, and affordable biomarker detection without having to invest in costly instruments and labor-intensive sample preparation procedures. The envisioned products will be assays, panels, and kits for the early detection of infectious and genetic diseases in non-laboratory settings. Specific Aims: 1. Development of ICR probes to sepsis target sequences: We will design and develop ICR assays to rapidly and isothermally detect synthetic target sequences associated with sepsis in a mixed population of templates in less than 10 minutes under isothermal conditions, without enzymes, primers, nucleotides, or master mixes. 2. Identification of known sepsis pathogens in blood samples: We will use ICR assays from Specific Aim 1 to identify known sepsis pathogens from retrospective blood samples. ICR results will be benchmarked to blood cultures to demonstrate the feasibility of using ICR for rapid early detection of sepsis biomarkers. 3. Identification of unknown sepsis pathogens in blood samples: We will use ICR assays from Specific Aim 1 to identify unknown sepsis pathogens from retrospective blood samples. ICR results will be benchmarked to blood cultures to demonstrate the feasibility that ICR has enhanced selectivity to detect pathogens missed by blood culture methods, and ICR is more amenable to point-of-care sepsis testing. Impact: Accomplishing the Specific Aims could significantly impact rapid and early detection of sepsis pathogens when therapeutic interventions are much more effective, and enable routine clinical testing and screening of the disease to improve clinical triage decisions, routine monitoring, and treatment outcomes.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2016	GENENDEAVOR LLC	26219 EDEN LANDING ROAD	HAYWARD	CA	94545	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	1	12/10/2019	NEW	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2016	GENENDEAVOR LLC	26219 EDEN LANDING ROAD	HAYWARD	CA	94545	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	1	6/12/2018	NEW	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $300,000 )
2016	2016	GENENDEAVOR LLC	43055 OSGOOD RD, UNIT B	FREMONT	CA	94539	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	1	6/10/2016	NEW	$300,000
														Subtotal = $300,000

Grand Total All Awards = $300,000

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Isothermal Chain Reaction (ICR) Rapid and Early Detection of Pathogens for Sepsis Pont-of-Care Testing, Stratification, and Monitoring

Award Number: R43AI126956

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2016

PERIOD OF PERFORMANCE END DATE: 06/30/2019

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