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Silicon Photonic Detection of anti-ABO Antibodies

Award Number: R43HL156294
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/01/2021
PERIOD OF PERFORMANCE END DATE: 09/30/2022

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Silicon Photonic Detection of anti-ABO Antibodies - Summary Problem: Detecting and quantifying Anti-ABO antibodies is essential for some medical procedures, such as whole blood transfusion and ABO-incompatible solid organ transplant and could greatly impact patient care for other indications, such as hemolytic disease of the fetus and newborn. However, current testing methods are encumbered by the need for large blood samples, transportation to centralized laboratories, time to centrifuge and perform testing of serial dilutions, specialized reagents and technical training needs, and technical variability between users and sites. Thus, there is a need for antibody detection and quantification that is standardized, multiplexed, and automated while simultaneously providing for speed and lower cost. Solution: SiDx has demonstrated the promise of our technology in proof-of-concept studies to detect A, B, RhD (D), C, E, and Kell blood group antigens in small volume blood samples and is working to multiplex these assays for commercialization. However, detection and quantification of anti-ABO antibodies presents further technical challenges. This SBIR application is seeking SBIR support to determine the feasibility of detecting and semi- quantitatively characterizing isotype-specific anti-ABO antibodies using silicon photonic biosensors. We propose to do this in two aims: In Aim 1, we propose developing proof-of-concept assays for IgG, IgM, and total anti- ABO antibodies. In Aim 2, we propose detecting and semi-quantitatively characterizing anti-ABO IgG antibodies in O-type samples over a physiologic range of titers. This work will provide data to support a SBIR phase II application in which we will propose optimization of the assays developed in phase I and quantitative analysis of IgG and IgM antibodies as well as providing a road map for future work on detection and quantification of other antibodies on our platform. Impact: This silicon photonic blood typing platform holds the promise to modernize blood group testing with simple, fast, fully automated, multiplexed blood group testing in small volume blood samples. The addition of quantitative and isotype-specific information about anti-ABO antibodies will increase the value of the SiDx platform by providing more actionable information in an easy to use automated test. We predict that this product will transform both blood group testing and transfusion medicine through small sample volume, fully automated testing, and rapid time to results.


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: 2023 ( Subtotal = $0 )
2023	2021	SIDX, INC.	4000 MASON RD STE 300	SEATTLE	WA	98195	KING	USA	Blood Diseases and Resources Research	000	1	11/4/2022	NEW	$0
2023	2021	SIDX, INC.	4000 MASON RD STE 300	SEATTLE	WA	98195	KING	USA	Blood Diseases and Resources Research	001	1	9/20/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $253,054 )
2021	2021	SIDX, INC.	4000 MASON RD STE 300	SEATTLE	WA	98195	KING	USA	Blood Diseases and Resources Research	000	1	12/11/2020	NEW	$253,054
														Subtotal = $253,054

Grand Total All Awards = $253,054

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Silicon Photonic Detection of anti-ABO Antibodies

Award Number: R43HL156294

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 01/01/2021

PERIOD OF PERFORMANCE END DATE: 09/30/2022

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