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FLOW CYTOMETRY-BASED UNSCHEDULED DNA SYNTHESIS (FLUDS)

Award Number: R44CA113243
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2004
PERIOD OF PERFORMANCE END DATE: 08/31/2006

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FLOW CYTOMETRY-BASED UNSCHEDULED DNA SYNTHESIS (FLUDS) - DESCRIPTION (provided by applicant): There is a growing need in industry for an inexpensive screening assay which can reliably determine the genotoxic potential of the large number of new chemical compounds synthesized each year. The Unscheduled DNA Synthesis (UDS) Assay is a proven method to identify and characterize genotoxic chemicals. However, several technical aspects of the standard assay limit its widespread use. We have made modifications to the standard UDS assay in Phase I studies through incorporation of flow cytometry as a detection method, and have proven feasibility of our optimized version of UDS, termed FLUDS. The FLUDS assay allows higher throughput and much shorter study times (a few days versus weeks for the standard UDS). This new assay can discriminate between innate and biotransformed genotoxicants, and is fully quantitative. It has reliably predicted the UDS induced by ethylnitrosourea, aphidicolin, 2- acetylaminofluorene, and fluorene. We intend to pre-validate the FLUDS assay by testing an expanded set of genotoxic and non-genotoxic chemicals in preparation for a multi-laboratory validation under ICCVAM guidelines. The pre-validated FLUDS assay would be of considerable commercial value to customers in the pharmaceutical, chemical, cosmetic and consumer products industries.


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: 2005 ( Subtotal = $489,302 )
2005	2005	MB RESEARCH LABORATORIES	1765 WENTZ ROAD	SPINNERSTOWN	PA	18968	BUCKS	USA	Cancer Cause and Prevention Research	000	3	8/29/2005	NON-COMPETING CONTINUATION	$489,302
														Subtotal = $489,302

Issue Date FY: 2004 ( Subtotal = $585,850 )
2004	2004	MB RESEARCH LABORATORIES	1765 WENTZ ROAD	SPINNERSTOWN	PA	18968	BUCKS	USA	Cancer Cause and Prevention Research	000	2	9/15/2004	OTHER REVISION	$585,850
														Subtotal = $585,850

Grand Total All Awards = $1,075,152

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FLOW CYTOMETRY-BASED UNSCHEDULED DNA SYNTHESIS (FLUDS)

Award Number: R44CA113243

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/15/2004

PERIOD OF PERFORMANCE END DATE: 08/31/2006

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