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Point-of-care screening test for early cervical cancer detection

Award Number: R01CA246315
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/22/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Point-of-care screening test for early cervical cancer detection - SUMMARY ABSTRACT Although cervical cancer is an easily curable disease if detected early, it continues to claim the lives of hundreds of thousands of women worldwide. Healthcare disparities have resulted in cervical cancer incidence and mortality that are five times higher in low and middle income countries (LMICs) than in high-income countries. In the United States, cervical cancer mortality rates are twice as high among rural women than their urban counterparts. The wide disparity in cervical cancer incidence rates and deaths is attributed to both higher HPV infection rates and a lack of accessible screening and treatment of pre-invasive cervical lesions. The current standard of care in the US, a cytology-based Pap smear, requires resource intensive laboratory and clinical specialists with a long turnaround time from sample collection to result. Alternatives, such as visual inspection with acetic acid and emerging HPV-targeted tests, have poor specificity for cervical cancer, leading to overtreatment that can cause complications including infertility and pre-term births and that further the burden on limited healthcare resources. This proposal aims to create an integrated point-of-care screening test that can be used by healthcare providers in under-resourced settings to obtain relevant clinical insights, including cervical cancer risk stratification, and enable same-visit treatment of high risk cervical lesions. Building on our preliminary development of a highly sensitive paper-based immunoassay to test for the key cervical cancer biomarker, valosin containing protein (VCP), the objective of this proposal is to combine VCP detection with three other known cervical cancer protein biomarkers, in a sensitive and specific single-step point- of-care assay. Specific milestones include: 1) Integrating and optimizing multiplex detection of cervical cancer biomarkers into a simple paper-based sample-to-answer device. 2) Evaluating the operational and performance metrics of the test in retrospective cervical swab samples. The outcome of this proposal will be a highly characterized point-of-care test with high sensitivity (95%) and specificity (90%) to detect high-risk cervical intraepithelial neoplasia and invasive cervical cancer within 40 minutes. This affordable solution for cervical cancer screening and control programs will be applicable in LMICs and will provide highly sensitive monitoring of cervical intraepithelial neoplasia in the US, where it will be especially impactful in high-risk populations that are currently underserved by existing screening programs.


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: 2024 ( Subtotal = $392,991 )
2024	2024	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE # 1100	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Cancer Detection and Diagnosis Research	000	5	6/11/2024	NON-COMPETING CONTINUATION	$392,991
														Subtotal = $392,991

Issue Date FY: 2023 ( Subtotal = $405,400 )
2023	2023	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE STE 1900	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Cancer Detection and Diagnosis Research	000	4	7/17/2023	NON-COMPETING CONTINUATION	$405,400
														Subtotal = $405,400

Issue Date FY: 2022 ( Subtotal = $392,792 )
2022	2022	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE STE 1900	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Cancer Detection and Diagnosis Research	000	3	6/17/2022	NON-COMPETING CONTINUATION	$392,792
														Subtotal = $392,792

Issue Date FY: 2021 ( Subtotal = $384,085 )
2021	2021	PURDUE UNIVERSITY	155 S GRANT ST	WEST LAFAYETTE	IN	47907	TIPPECANOE	USA	Cancer Detection and Diagnosis Research	000	2	7/1/2021	NON-COMPETING CONTINUATION	$384,085
														Subtotal = $384,085

Issue Date FY: 2020 ( Subtotal = $384,085 )
2020	2020	PURDUE UNIVERSITY	155 S GRANT ST	WEST LAFAYETTE	IN	47907	TIPPECANOE	USA	Cancer Detection and Diagnosis Research	000	1	9/22/2020	NEW	$384,085
														Subtotal = $384,085

Grand Total All Awards = $1,959,353

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Point-of-care screening test for early cervical cancer detection

Award Number: R01CA246315

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/22/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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