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A New Rapid DNA Platform for Neonatal Sepsis Diagnostics

Award Number: R43HD084019
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: 11/30/2016

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A New Rapid DNA Platform for Neonatal Sepsis Diagnostics - ¿ DESCRIPTION (provided by applicant): 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 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 in 2 to 3 days which often does not provide timely results for neonatal sepsis cases. Typical neonatal patients are weighing 1,000 grams or less and their total blood volume may be as low as ~ 50 mL, thus the iatrogenic blood loss for premature babies may represent up to 12% - 31% of total blood loss due to phlebotomy. New point-of-care methods with faster detection time and using smaller amounts of sample are urgently needed. Molecular assays based on DNA specificity for sepsis pathogens represent a promising diagnostic tool for early identification of bacteremia. However, today 90% of hospitals in USA 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 (maximum 4-6) 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 min and that is capable of using very small sample volumes, as low as 2 - 200 microliters, compatible with the neonatal sepsis detection. Multiplexed identification of the neonatal sepsis pathogens is enable using the microarray approach. In addition, a number of innovations are offered in the project that will bring a 5 fold decrease in the cost of instrumentation and cartridges compared to the commercialized platforms. The platform also offers a unique new qualitative parameter in DNA/RNA diagnostics that will enable integration of data for both the length of the nucleic acids as well as it will preserve the strand specificity, e.g., important in alternative splicing mechanisms. The assay development in the Phase I will focus on representative neonatal sepsis pathogens and will establish the basic platform, and cartridge prototypes and will provide a thorough validation of the assays developed using de- identified archived clinical samples.


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: 2017 ( Subtotal = $0 )
2017	2015	NEXOGEN, INC.	7939 SILVERTON AVE. STE 806	SAN DIEGO	CA	92126	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	1	3/27/2017	NEW	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $218,289 )
2015	2015	NEXOGEN INC	9412 MALER ROAD	SAN DIEGO	CA	92129	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	1	9/18/2015	NEW	$218,289
														Subtotal = $218,289

Grand Total All Awards = $218,289

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A New Rapid DNA Platform for Neonatal Sepsis Diagnostics

Award Number: R43HD084019

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: 11/30/2016

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