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Point of Care HPV 16/18/45 DNA Test for Cervical Cancer

Award Number: R44CA250663
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/22/2023
PERIOD OF PERFORMANCE END DATE: 02/28/2026

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Point of Care HPV 16/18/45 DNA Test for Cervical Cancer - Point of Care HPV 16/18/45 DNA Test for Cervical Cancer. CrossLife Technologies Inc. Project Summary/Abstract Human cervical cancer is the fourth most common cancer among women worldwide [1]. Despite cervical cancer has been thoroughly studied and the mortality has been significantly reduced through efficient screening, these preventive programs are found to be less effective in developing countries [2-3]. There are unmet needs for nucleic acids new diagnostics that can be applied at the point-of-care to detect HPV 16/18/45 DNA for cervical cancer. A simple, sensitive, multiplex and robust testing kits for detecting cervical cancer biomarker HPV 16/18/45 DNA at the point-of-care will be developed. The competitive advantage of TARA is the utilization of a novel chemical reaction with similar detection sensitivity and specificity compared to the Hologic Aptima HPV 16 18/45 Genotype assay and simple readout on paper-strip more suitable for field devices without an instrument. TARA also offers the potential for direct detection in complex sample matrices, such as cervical sample or blood, without sample preparation. Building on the chemistry and device innovations (TARAplex, and 1D paper network), we have made significant progress and begun to explore integration through our established collaborations. We aim to develop a rapid point-of-test that detects HPV at the point-of-need in < 30 minutes and is appropriate for non-laboratory settings and non-technical personnel. Our proprietary test exploits a novel probe reaction chemistry that allows multiplexed detection of DNA or RNA without sample purification, making it operable as a simple, hand-held test. Patient samples to be input directly into the device without pre-processing and a disposable cartridge carry out amplification of all targets and reports visible results that can be read by eye. We expect a sensitivity (>90%) and specificity (>90%) to the U.S. commercially-available the Aptima HPV 16 18/45 Genotype assay (HOLOGIC) data on the same samples. We will conduct a large-scale validation and obtain World Health Organization (WHO) expedited review approval and recommendation for procurement on our product and market it first to non-governmental organizations (NGO) such as the Doctors Without Borders or the Gates Foundation. We will obtain USFDA 510 K clearance in Phase 3 in order to market our product in the U.S.


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 = $994,439 )
2025	2025	CROSSLIFE TECHNOLOGIES INC.	5937 DARWIN CT	CARLSBAD	CA	92008	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	3	4/24/2025	NON-COMPETING CONTINUATION	$994,439
														Subtotal = $994,439

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	CROSSLIFE TECHNOLOGIES INC.	5937 DARWIN CT	CARLSBAD	CA	92008	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	2	9/9/2024	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $994,004 )
2023	2023	CROSSLIFE TECHNOLOGIES INC.	5937 DARWIN CT	CARLSBAD	CA	92008	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	001	2	9/18/2023	EXTENSION WITH OR WITHOUT FUNDS	$994,004
2023	2020	CROSSLIFE TECHNOLOGIES INC.	5937 DARWIN CT	CARLSBAD	CA	92008	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	1	5/22/2023	NEW	$0
														Subtotal = $994,004

Issue Date FY: 2020 ( Subtotal = $299,945 )
2020	2020	CROSSLIFE TECHNOLOGIES INC.	5937 DARWIN COURT, #105	CARLSBAD	CA	92008	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	1	5/14/2020	NEW	$299,945
														Subtotal = $299,945

Grand Total All Awards = $2,288,388

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Point of Care HPV 16/18/45 DNA Test for Cervical Cancer

Award Number: R44CA250663

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/22/2023

PERIOD OF PERFORMANCE END DATE: 02/28/2026

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