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SIMPLE AND RAPID ON-SITE MOLECULAR DETECTION OF MYCOBACTERIUM TUBERCULOSIS

Award Number: R43AI077025
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: 02/01/2008
PERIOD OF PERFORMANCE END DATE: 12/31/2008

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SIMPLE AND RAPID ON-SITE MOLECULAR DETECTION OF MYCOBACTERIUM TUBERCULOSIS - DESCRIPTION (provided by applicant): This SBIR Phase I application will focus on the development of a simple and inexpensive, handheld, battery-operated biosensor integrating microfluidics and molecular biology to rapidly detect Mycobacterium tuberculosis, the etiologic agent of tuberculosis (TB) in humans. With as many as 9 million new cases of TB and approximately 2 million deaths per year and the difficulties encountered in resource-limited countries to accurately diagnose TB, the World Health Organization has urged the development of new diagnostic platforms for the detection of M. tuberculosis. Relying upon 100-year old microscopic methods that lack sensitivity, resource-limited countries represent a major market for a successful product. Furthermore, the risk of transmission of multi-drug resistant TB to industrialized nations via the availability of air travel makes this a global health issue. With almost $ 1.0 Billion spent every year to perform TB testing, the commercial market potential for an easy-to-use test for M. tuberculosis is immediate and will have broad implications for improving a worldwide health issue. In order to exploit modern molecular biology detection methods without imposing a need for expensive equipment and time-consuming analytical steps, we propose to utilize two different sets of oligonucleotide probes complementary to a M. tuberculosis rRNA sequence. One set will be bound to magnetic beads while a second set will be conjugated to liposomes that encapsulate enzyme substrates. The resulting hybridization complex will be immobilized via a magnet within a microfluidic device. Liposomes will then be lysed allowing the now released enzyme substrates to drive an electrochemical reaction that will be quantitated by an integrated interdigitated ultramicroelectrode array (IDUA). Thus, the IDUA will transduce the biological signal into a digital electronic signal. The accomplishment of these goals and objectives will permit the direct detection of M. tuberculosis rRNA without the need for time-consuming enrichment or gene amplification steps. Furthermore, it is anticipated that this easy-to-use diagnostic test will permit near-patient testing by individuals who will not require extensive training and background in molecular biology. Successful completion of the proposed Phase I effort will result in a unique biosensor, capable of rapidly detecting Mycobacterium tuberculosis, the causative agent of TB. Inasmuch as more than two-thirds of the world's TB cases are found in resource-limited countries that lack the financial or technical resources to accurately diagnose new TB cases or monitor treatment of existing cases, such a biosensor will have an immediate and dramatic impact on improving the health of individuals living in such countries. Furthermore, since TB can be efficiently spread by airborne transmission, the ability to control TB in those portions of the world with high infection rates will also reduce the risk of spreading TB, including that caused by multi-drug resistant strains of M. tuberculosis, to industrialized nations.


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: 2011 ( Subtotal = -$99,975 )
2011	2008	INNOVATIVE BIOTECHNOLOGIES INTERNATIONAL	335 LANG BLVD	GRAND ISLAND	NY	14072	ERIE	USA	Allergy and Infectious Diseases Research	000	1	1/27/2011	NEW	-$99,975
														Subtotal = -$99,975

Issue Date FY: 2009 ( Subtotal = $99,975 )
2009	2008	INNOVATIVE BIOTECHNOLOGIES INTERNATIONAL	335 LANG BLVD	GRAND ISLAND	NY	14072	ERIE	USA	Allergy and Infectious Diseases Research	000	1	3/27/2009	NEW	$0
2009	2008	RHEONIX INC	22 THORNWOOD DRIVE	ITHACA	NY	14850	TOMPKINS	USA	Allergy and Infectious Diseases Research	001	2	3/27/2009	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$99,975
														Subtotal = $99,975

Issue Date FY: 2008 ( Subtotal = $99,975 )
2008	2008	INNOVATIVE BIOTECHNOLOGIES INTERNATIONAL	335 LANG BLVD	GRAND ISLAND	NY	14072	ERIE	USA	Allergy and Infectious Diseases Research	000	1	1/25/2008	NEW	$99,975
														Subtotal = $99,975

Grand Total All Awards = $99,975

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SIMPLE AND RAPID ON-SITE MOLECULAR DETECTION OF MYCOBACTERIUM TUBERCULOSIS

Award Number: R43AI077025

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: 02/01/2008

PERIOD OF PERFORMANCE END DATE: 12/31/2008

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