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A RAPID AND EXPANDABLE NUCLEIC ACID PLATFORM TO DETECT BLOODSTREAM INFECTIONS

Award Number: U01AI066561
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/14/2005
PERIOD OF PERFORMANCE END DATE: 03/31/2011

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A RAPID AND EXPANDABLE NUCLEIC ACID PLATFORM TO DETECT BLOODSTREAM INFECTIONS - DESCRIPTION (provided by applicant): Blood stream infections (BSIs) are a significant cause of morbidity and mortality in the USA. While the true incidence of nosocomial BSIs is unknown, several studies have reported that an estimated 250,000 cases occur annually. There is evidence to show that early and appropriate antimicrobial therapy is an important contributor to a favorable outcome for patients with BSI. Current diagnostic methods can take from 24 hours up to a week or more for positive pathogen identification and characterization. The reduction of the time period from specimen collection until the availability of species identification and antimicrobial susceptibility is therefore critical in improving outcomes for patients with severe bloodstream infections. No molecular diagnostic tool is currently available to clinical microbiology laboratories that have been validated against the existing gold standard methods for pathogen identification, and susceptibility testing. We plan to develop in close collaboration with bioMerieux, a global leader in clinical diagnostics, a next-generation nucleic acid based NASBA-Molecular Beacons platform for rapid identification of bacterial and fungal pathogens, and associated drug resistance in selected organisms. Three clinical sites in New York (USA), Toronto (CAN) and Manchester (UK) have been selected to evaluate the new platform in relation to an existing culturebased gold standard. These large tertiary care medical centers will create a robust environment to conduct the studies. They all provide complex intensive care services (greater than 300 beds total) to highly diverse at risk populations, have leading infectious diseases clinical researchers, and a clinical microbiology laboratory with the expertise and the experience necessary to conduct the evaluation. This comprehensive approach joining PHRI's technical expertise in molecular beacon probe development with bioMerieux NASBA technology and clinical diagnostic product development, along with outstanding clinical partners will help ensure that a product applicable to improving Sepsis outcome will emerge.


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: 2010 ( Subtotal = $72,359 )
2010	2009	UNIVERSITY OF MEDICINE & DENTISTRY OF NEW JERSEY	65 BERGEN STREET	NEWARK	NJ	07107	ESSEX	USA	Allergy and Infectious Diseases Research	001	6	3/29/2010	NON-COMPETING CONTINUATION	$0
2010	2009	UNIVERSITY OF MEDICINE & DENTISTRY OF NEW JERSEY	65 BERGEN STREET	NEWARK	NJ	07107	ESSEX	USA	Allergy and Infectious Diseases Research	000	6	3/29/2010	NON-COMPETING CONTINUATION	$72,359
														Subtotal = $72,359

Issue Date FY: 2009 ( Subtotal = $1,059,362 )
2009	2009	UNIVERSITY OF MEDICINE & DENTISTRY OF NEW JERSEY	65 BERGEN STREET	NEWARK	NJ	07107	ESSEX	USA	Trans-NIH Recovery Act Research Support	002	6	9/7/2009	SUPPLEMENT FOR EXPANSION	$335,767
2009	2009	UNIVERSITY OF MEDICINE & DENTISTRY OF NEW JERSEY	65 BERGEN STREET	NEWARK	NJ	07107	ESSEX	USA	Allergy and Infectious Diseases Research	001	6	6/9/2009	NON-COMPETING CONTINUATION	$72,359
2009	2009	UNIVERSITY OF MEDICINE & DENTISTRY OF NEW JERSEY	65 BERGEN STREET	NEWARK	NJ	07107	ESSEX	USA	Allergy and Infectious Diseases Research	000	6	2/24/2009	NON-COMPETING CONTINUATION	$651,236
														Subtotal = $1,059,362

Issue Date FY: 2008 ( Subtotal = $757,554 )
2008	2008	UNIVERSITY OF MEDICINE & DENTISTRY OF NEW JERSEY	65 BERGEN STREET	NEWARK	NJ	07101	ESSEX	USA	Allergy and Infectious Diseases Research	000	5	4/22/2008	NON-COMPETING CONTINUATION	$757,554
														Subtotal = $757,554

Issue Date FY: 2007 ( Subtotal = $638,889 )
2007	2007	UNIVERSITY OF MEDICINE & DENTISTRY OF NEW JERSEY	65 BERGEN STREET	NEWARK	NJ	07101	ESSEX	USA	Allergy and Infectious Diseases Research	000	4	9/4/2007	NON-COMPETING CONTINUATION	$638,889
														Subtotal = $638,889

Issue Date FY: 2006 ( Subtotal = $573,544 )
2006	2006	PUBLIC HEALTH RESEARCH INSTITUTE OF NEW YORK CITY	225 WARREN STREET, SUITE E230F	NEWARK	NJ	07103	ESSEX	USA	Allergy and Infectious Diseases Research	000	2	4/10/2006	NON-COMPETING CONTINUATION	$573,544
														Subtotal = $573,544

Grand Total All Awards = $3,101,708

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A RAPID AND EXPANDABLE NUCLEIC ACID PLATFORM TO DETECT BLOODSTREAM INFECTIONS

Award Number: U01AI066561

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 07/14/2005

PERIOD OF PERFORMANCE END DATE: 03/31/2011

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