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Rapid LFIA blood test for SCD using highly specific monoclonal antibodies

Award Number: R43HL123670
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2014
PERIOD OF PERFORMANCE END DATE: 07/31/2016

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Rapid LFIA blood test for SCD using highly specific monoclonal antibodies - DESCRIPTION (provided by applicant): Neonatal screening for sickle cell disease (SCD) and other hemoglobinopathies has been shown to reduce morbidity and mortality of affected individuals through early intervention, and to also reduce the healthcare burden of this common group of disorders. However, traditional screening methods are laborious and costly, and thereby often inappropriate for low-resource settings in areas of high prevalence of SCD. We propose the development of a rapid, simple, and inexpensive lateral-flow immunoassay (LFIA) test kit for the point-of-care detection of hemoglobin phenotypes directly in whole blood samples. This convenient and inexpensive assay format has proven to be an accurate and reliable diagnostic methodology for a variety of POC applications where a rapid assay is needed. The proposed LFIA for hemoglobin phenotypes will utilize highly specific monoclonal antibodies (MAbs) for HbA, HbS, and HbC, recently developed by Silver Lake Research using a proprietary antibody generation system. By using these MAbs in a single test, the proposed LFIA will be able to identify and distinguish between the most common SCD phenotypes including normal (HbAA), HbSS, HbAS, HbCC, HbSC, and HbS/boThal. The proposed test kit will also include an inexpensive, disposable sample preparation component, capable of rapidly preparing a whole blood sample or dried blood spot filter for analysis by the LFIA test strip. SLRC's existing LFIA formats, used in tests currently manufactured by the Company, share a low-cost production platform that will enable the delivery of tests to the end-user at < $2 per unit. SLRC has over 15 years of experience in LFIA development and production, with more than 20 marketed LFIA products originally designed, developed, and manufactured at SLRC.


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: 2018 ( Subtotal = $0 )
2018	2015	SILVER LAKE RESEARCH CORPORATION	1300 WEST OPTICAL DR STE 300	AZUSA	CA	91702	LOS ANGELES	USA	Blood Diseases and Resources Research	000	2	7/24/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $221,502 )
2015	2015	SILVER LAKE RESEARCH CORPORATION	911 SOUTH PRIMROSE AVENUE	MONROVIA	CA	91016	LOS ANGELES	USA	Blood Diseases and Resources Research	000	2	6/9/2015	NON-COMPETING CONTINUATION	$221,502
														Subtotal = $221,502

Issue Date FY: 2014 ( Subtotal = $221,510 )
2014	2014	SILVER LAKE RESEARCH CORPORATION	911 SOUTH PRIMROSE AVENUE	MONROVIA	CA	91016	LOS ANGELES	USA	Blood Diseases and Resources Research	000	1	8/1/2014	NEW	$221,510
														Subtotal = $221,510

Grand Total All Awards = $443,012

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Rapid LFIA blood test for SCD using highly specific monoclonal antibodies

Award Number: R43HL123670

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2014

PERIOD OF PERFORMANCE END DATE: 07/31/2016

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