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A New Rapid DNA Platform for Neonatal Sepsis Diagnostics

Award Number: R44HD084019
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/18/2015
PERIOD OF PERFORMANCE END DATE: 03/31/2021

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A New Rapid DNA Platform for Neonatal Sepsis Diagnostics - Project Summary Severe sepsis strikes more than a million patients in USA per year and it has been estimated that between 28% and 50% percent of these patients die, exceeding the number of U.S. deaths from prostate cancer, breast cancer and AIDS combined. Neonatal sepsis causes over one million death per year worldwide and 5% to 60% of infants treated with antibiotics die despite the treatment, with higher rates occurring in low income countries. Rapid and accurate diagnosis of sepsis in NICUs (Neonatal Intensive Care Units) is crucial for implementing a timely treatment. Because sepsis is a life-threatening medical emergency a large proportion of infants receive treatment with potent systemic antibiotics that can adversely lead to destruction of the infant’s normal gastrointestinal flora and the risk of becoming colonized with drug-resistant microorganisms. Blood culturing is used as the gold standard for neonatal diagnosis of sepsis, however the samples are returned after 48 hrs which often does not provide timely results for neonatal sepsis treatment. Multiple sampling that will increase accuracy of neonatal diagnosis by culturing is minimized because the iatrogenic blood loss may represent up to 12% - 31% of total blood in premature babies. New point-of-care methods with faster detection time and more accurate to use smaller amounts of sample are urgently needed. Molecular DNA-based assays have been introduced into the CDC Guidelines for neonatal sepsis diagnosis but current methods lack accuracy, need enrichment of samples and cannot provide the needed multiplexed pathogen identification. However, today 90% of hospitals in USA and world cannot perform DNA analysis and samples are sent to the centralized reference labs with the response time of 2-3 days. The current point-of-care diagnostics are mostly based on the real-time PCR methods that are limited by the number of colors for detecting multiple organisms or by the high price of the instrument or assay cost. This project introduces a new point-of-care (POC) rapid method for DNA/RNA diagnostics that will approach total assay turn-around time of ~15-20 min and that can use very small sample volumes, as low as 5 - 200 microliters, compatible with the neonatal sepsis detection. Multiplexed identification of the neonatal sepsis pathogens is enabled using the microarray approach. The proposed technology will enable a new diagnostic approach that could more rapidly identify neonatal pathogens including hospital associated infections and antibiotic resistant pathogens yielding a more tailored administration of regimen of antibiotics and promoting a judicious use of antibiotics. Several innovations in manufacturing of cartridge disposable and instrument will bring a 5-8-fold decrease in the cost of instrumentation and cartridges compared to the commercialized platforms. The Phase II project will focus on the platform and neonatal sepsis/HAI assay development; however, it is envisioned that the platform will find other broad applications in decentralized, urgent care settings as well as in hospitals.


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: 2021 ( Subtotal = $0 )
2021	2019	NEXOGEN, INC.	7939 SILVERTON AVE. STE 806	SAN DIEGO	CA	92126	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	3	9/28/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $489,497 )
2019	2019	NEXOGEN, INC.	7939 SILVERTON AVE. STE 806	SAN DIEGO	CA	92126	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	3	3/19/2019	NON-COMPETING CONTINUATION	$489,497
														Subtotal = $489,497

Issue Date FY: 2018 ( Subtotal = $494,099 )
2018	2018	NEXOGEN, INC.	7939 SILVERTON AVE. STE 806	SAN DIEGO	CA	92126	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	2	4/20/2018	COMPETING CONTINUATION	$494,099
														Subtotal = $494,099

Grand Total All Awards = $983,596

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A New Rapid DNA Platform for Neonatal Sepsis Diagnostics

Award Number: R44HD084019

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/18/2015

PERIOD OF PERFORMANCE END DATE: 03/31/2021

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