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Evaluation of Population Based Testing for HBOC and Lynch Syndromes

Award Number: U01CA232819
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/10/2020
PERIOD OF PERFORMANCE END DATE: 05/31/2025

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Evaluation of Population Based Testing for HBOC and Lynch Syndromes - SUMMARY The standard of care for genetic testing of hereditary breast and ovarian cancer (HBOC) syndrome and Lynch syndrome is based on guidelines from the NCCN. The paradigm was developed based on the principle that genetic testing was expensive and that the incidence of these syndromes was low. Over the past twenty years the price of testing has fallen dramatically and it is now recognized that both HBOC and Lynch syndrome are relatively common (joint incidence of about 1 in 200). Many individuals in the population are affected by HBOC or Lynch but come from small families with few female relatives. Given the decreases in family size that have occurred over the past 50 years this is becoming a common situation. It is estimated that only 20% of those affected by HBOC are aware of their condition. Overall, there is a significant unmet need for those with HBOC and Lynch syndrome to be identified so they can have the opportunity for appropriate medical care. What we need are approaches that can rapidly, accurately, and inexpensively identify those with inherited cancer syndromes. The costs of sequencing have fallen dramatically and members of our team have QIAseq based targeted resequencing platforms for germline studies that dramatically lower the cost of panel based sequencing while allowing easy, rapid multiplexing. The costs of testing will be near $90 per sample. We have taken the task of developing a strategy that can be applied to detect HBOC and Lynch syndromes in broader populations. We will study the effectiveness of population scale testing of these two syndromes by enrolling 27,500 individuals, who are (a) eligible for inherited cancer syndrome testing (2,500) (b) have had cancer but are not covered by current screening guidelines to receive a low cost genetic screen (7,500) or (c) healthy (17,500). Those individuals identified to have Lynch or HBOC will be followed for outcomes and compared to a matched cohort identified following standard screening guidelines. Additionally, relatives of those identified will be enrolled in cascade screening. We will determine if testing either cancer patients or the general population represents a sustainable strategy for population screening based on QALY measurements.


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: 2025 ( Subtotal = $0 )
2025	2020	OREGON HEALTH & SCIENCE UNIVERSITY	3181 SW SAM JACKSON PARK RD	PORTLAND	OR	97239	MULTNOMAH	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	9/22/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	OREGON HEALTH & SCIENCE UNIVERSITY	3181 SW SAM JACKSON PARK RD	PORTLAND	OR	97239	MULTNOMAH	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	11/6/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $161,578 )
2023	2023	OREGON HEALTH & SCIENCE UNIVERSITY	3181 SW SAM JACKSON PARK RD	PORTLAND	OR	97239	MULTNOMAH	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	002	1	9/14/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2023	OREGON HEALTH & SCIENCE UNIVERSITY	3181 SW SAM JACKSON PARK RD	PORTLAND	OR	97239	MULTNOMAH	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	1	9/13/2023	SUPPLEMENT FOR EXPANSION	$161,578
2023	2023	OREGON HEALTH & SCIENCE UNIVERSITY	3181 SW SAM JACKSON PARK RD	PORTLAND	OR	97239	MULTNOMAH	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	003	1	9/22/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2020	OREGON HEALTH & SCIENCE UNIVERSITY	3181 SW SAM JACKSON PARK RD	PORTLAND	OR	97239	MULTNOMAH	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	9/7/2023	NEW	$0
														Subtotal = $161,578

Issue Date FY: 2020 ( Subtotal = $6,132,471 )
2020	2020	OREGON HEALTH & SCIENCE UNIVERSITY	3181 SW SAM JACKSON PARK RD	PORTLAND	OR	97239	MULTNOMAH	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	6/10/2020	NEW	$6,132,471
														Subtotal = $6,132,471

Grand Total All Awards = $6,294,049

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Evaluation of Population Based Testing for HBOC and Lynch Syndromes

Award Number: U01CA232819

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 06/10/2020

PERIOD OF PERFORMANCE END DATE: 05/31/2025

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