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Automated Ultrasensitive Detection of Light Chain Restriction in Lymphoproliferat

Award Number: R44CA168019
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/14/2012
PERIOD OF PERFORMANCE END DATE: 12/31/2016

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Automated Ultrasensitive Detection of Light Chain Restriction in Lymphoproliferat - DESCRIPTION (provided by applicant): Immunoglobulin (Ig) light chain restriction (LCR) detection is an important molecular diagnostic tool in the differential diagnosis that includes lymphoid hyperplasia, atypical lymphoid hyperplasia, chronic inflammation, and B cell neoplasms. LCR can be detected by flow cytometry (FCM) as an abnormal kappa:lambda ratio on the cell surface. However, FCM requires fresh (unfixed) tissue. Some B cell lymphomas lack surface Ig expression detectable by FCM, some demonstrate nonspecific antibody binding. Often only formalin-fixed paraffin-embedded (FFPE) tissue is available for pathologic evaluation. Current methods of LCR identification in FFPE tissue include immunohistochemistry (IHC) and conventional chromogenic in situ hybridization (CISH), which measure kappa or lambda protein and mRNA, respectively. However, both IHC and conventional CISH lack sufficient sensitivity to detect LCR in many non-Hodgkin lymphoma (NHL), including the most common NHL variants - follicular lymphoma, diffuse large B cell lymphoma, small B lymphocytic lymphoma, and extranodal marginal zone lymphoma of MALT type. RNAscope is a novel RNA in situ hybridization technology which has single-molecule detection sensitivity and is fully compatible with FFPE tissue using either chromogenic or fluorescent detection. We have developed a manual bright-field kappa and lambda duplex RNA ISH assay for LCR, which has demonstrated broad applicability to all NHL subtypes. In this project, we will develop a fully automated duplex RNAscope LCR assay with digital pathology interpretation, which should greatly facilitate clinical adoption of this novel assay.


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 = -$661,306 )
2017	2015	ADVANCED CELL DIAGNOSTICS, INC.	7707 GATEWAY BLVD	NEWARK	CA	94560	ALAMEDA	USA	Cancer Detection and Diagnosis Research	001	3	5/9/2017	NON-COMPETING CONTINUATION	-$529,530
2017	2014	ADVANCED CELL DIAGNOSTICS, INC.	7707 GATEWAY BLVD	NEWARK	CA	94560	ALAMEDA	USA	Cancer Detection and Diagnosis Research	000	2	5/9/2017	COMPETING CONTINUATION	-$131,776
														Subtotal = -$661,306

Issue Date FY: 2015 ( Subtotal = $529,530 )
2015	2015	ADVANCED CELL DIAGNOSTICS INC	6519 DUMBARTON CIRCLE	FREMONT	CA	94555	ALAMEDA	USA	Cancer Detection and Diagnosis Research	000	3	8/6/2015	NON-COMPETING CONTINUATION	$529,530
														Subtotal = $529,530

Issue Date FY: 2014 ( Subtotal = $834,236 )
2014	2014	ADVANCED CELL DIAGNOSTICS INC	6519 DUMBARTON CIRCLE	FREMONT	CA	94555	ALAMEDA	USA	Cancer Detection and Diagnosis Research	000	2	9/26/2014	COMPETING CONTINUATION	$834,236
														Subtotal = $834,236

Grand Total All Awards = $702,460

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Automated Ultrasensitive Detection of Light Chain Restriction in Lymphoproliferat

Award Number: R44CA168019

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/14/2012

PERIOD OF PERFORMANCE END DATE: 12/31/2016

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