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Genetic Cytology for Ovarian and Endometrial Cancer Screening

Award Number: R44CA203350
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/20/2019
PERIOD OF PERFORMANCE END DATE: 06/30/2022

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Genetic Cytology for Ovarian and Endometrial Cancer Screening - DESCRIPTION (provided by applicant): In this Fast Track application, a path to commercialization will be pursued for a breakthrough "genetic cytology" test capable of detecting both ovarian and endometrial cancer from routinely collected Pap specimens. In deference to the notable success of the Pap test in reducing deaths due to cervical cancer, and in reference to the core enabling genetic sequencing technology, this new test has been named PapGene. The PapGene test detects ovarian and endometrial cancers by applying newly affordable sequencing technology to Pap specimens; specimens that are safely and routinely collected from 50 million women each year in the United States. The PapGene test is a genetic cytology assay that achieves sensitivity and specificity through identifying DNA mutations causative of cancer from routinely collected clinical specimens. With traditional cytology (e.g., Pap testing), cells are subjectively analyzed for abnormal cell morphology through visualization by light microscopy. The PapGene test allows cells to be analyzed objectively with a massively parallel sequencing-based assay. The test uses a proprietary sequencing error-reducing strategy to accommodate the relatively low proportions of cancer-derived DNA that may exist in clinical specimens. In Phase I, this study will determine the accuracy, precision, analytical sensitivity, analytical specificity, reportable range, and reference range of the PapGene genetic cytology assay (Aim 1). A retrospective study will also be completed on previously-collected samples to demonstrate the clinical validity of the PapGene assay (Aim 2). In Phase II, this study will demonstrate clinical utility of the PapGene test for women at high risk for ovarian and endometrial cancer. A prospective study will be completed by applying the PapGene assay to two prospective cohorts - patients with postmenopausal bleeding undergoing endometrial biopsy and patients with a germline BRCA1 or BRCA2 undergoing Risk Reducing Salpingo-Oophorectomy (RRSO) (Aim 3). Regulatory approval for the PapGene test will be pursued by establishing a CLIA-certified laboratory for high-complexity testing to allow for commercial use of a Laboratory Developed Test (LDT). Discussions with the FDA will be started regarding premarket clearance and approval for the PapGene test to allow for more widely distributed use (Aim 4).


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 = -$83,802 )
2023	2017	EXACT SCIENCES THRIVE LLC	222 JACOBS ST	CAMBRIDGE	MA	02141	MIDDLESEX	USA	Cancer Treatment Research	000	5	10/1/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$83,802
														Subtotal = -$83,802

Issue Date FY: 2022 ( Subtotal = -$1,800 )
2022	2017	PAPGENE, INC.	1812 ASHLAND AVE STE 640	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Cancer Treatment Research	001	3	6/29/2022	NON-COMPETING CONTINUATION	-$1,800
2022	2017	EXACT SCIENCES THRIVE LLC	222 JACOBS ST FL 9	CAMBRIDGE	MA	02141	MIDDLESEX	USA	Cancer Treatment Research	000	5	12/2/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = -$1,800

Issue Date FY: 2021 ( Subtotal = -$1 )
2021	2017	EXACT SCIENCES THRIVE LLC	222 JACOBS ST FL 9	CAMBRIDGE	MA	02141	MIDDLESEX	USA	Cancer Treatment Research	001	5	9/15/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$83,802
2021	2017	THRIVE EARLIER DETECTION CORP.	38 SIDNEY ST FL 3	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Cancer Treatment Research	000	4	9/15/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$83,803
														Subtotal = -$1

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2017	PAPGENE, INC.	1812 ASHLAND AVE STE 640	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Cancer Treatment Research	000	3	7/15/2020	NON-COMPETING CONTINUATION	-$83,803
2020	2017	THRIVE EARLIER DETECTION CORP.	38 SIDNEY ST FL 3	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Cancer Treatment Research	002	4	9/1/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2020	2017	THRIVE EARLIER DETECTION CORP.	38 SIDNEY ST FL 3	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Cancer Treatment Research	001	4	7/15/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$83,803
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $994,554 )
2017	2017	PAPGENE, INC.	810 WYMAN PARK DR	BALTIMORE	MD	21211	BALTIMORE CITY	USA	Cancer Treatment Research	000	3	8/15/2017	NON-COMPETING CONTINUATION	$994,554
														Subtotal = $994,554

Issue Date FY: 2016 ( Subtotal = $1,286,663 )
2016	2016	PAPGENE, INC.	810 WYMAN PARK DR	BALTIMORE	MD	21211	BALTIMORE CITY	USA	Cancer Treatment Research	001	1	8/26/2016	NEW	$0
2016	2016	PAPGENE, INC	810 WYMAN PARK DR	BALTIMORE	MD	21211	BALTIMORE CITY	USA	Cancer Treatment Research	002	2	8/31/2016	EXTENSION WITH OR WITHOUT FUNDS	$989,879
2016	2016	PAPGENE, INC	810 WYMAN PARK DR	BALTIMORE	MD	21211	BALTIMORE CITY	USA	Cancer Treatment Research	000	1	1/20/2016	NEW	$296,784
														Subtotal = $1,286,663

Grand Total All Awards = $2,195,614

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Genetic Cytology for Ovarian and Endometrial Cancer Screening

Award Number: R44CA203350

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/20/2019

PERIOD OF PERFORMANCE END DATE: 06/30/2022

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