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Rapid, Multiplexed Biosensor for Non-Invasive Detection of Gene Mutations and Personalization of Therapy in Non-Small Cell Lung Cancer

Award Number: R44CA240021
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/17/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Rapid, Multiplexed Biosensor for Non-Invasive Detection of Gene Mutations and Personalization of Therapy in Non-Small Cell Lung Cancer - PROJECT SUMMARY/ABSTRACT Rapid, Multiplexed Biosensor for Non-Invasive Detection of Gene Mutations and Personalization of Therapy in Non-Small Cell Lung Cancer There is an urgent need for improved blood-based liquid biopsies to aid the detection circulating tumor DNA (ctDNA). Such assays will be revolutionary for guiding cancer treatment because ctDNA is a very specific cancer biomarker that can be collected non-invasively, thus addressing the challenges of traditional invasive tissue biopsies. Detection of ctDNA is challenging because these biomarkers exist at trace concentrations and are vastly outnumbered by background wild type DNA. Giner, Inc. proposes to develop an electrochemical detection method for rapid, sensitive, and selective detection of single-base mutations in the EGFR gene associated with sensitivity to the tyrosine kinase inhibitor (TKI) class of drugs in non-small cell lung cancer (NSCLC). The developed assay will be adapted for multiplexed ctDNA detection, validated with lung cancer patient plasma samples, and integrated into a prototype microfluidic device, thus achieving a significant milestone toward regulatory evaluation. This technology will help increase access of personalized therapies to NSCLC patients for better treatment outcomes, and offer a compelling competitive advantage over gold standard digital PCR tests in terms of lower cost, minimized sample preparation requirements, increased multiplexed detection, and a much faster sample-to-answer turnaround time.


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: 2026 ( Subtotal = $0 )
2026	2023	GINER, INC.	89 RUMFORD AVE	AUBURNDALE	MA	02466	MIDDLESEX	USA	Cancer Detection and Diagnosis Research	000	3	1/14/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	GINER INC	89 RUMFORD AVE	AUBURNDALE	MA	02466	MIDDLESEX	USA	Cancer Detection and Diagnosis Research	000	3	8/15/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $976,557 )
2023	2023	GINER INC	89 RUMFORD AVE	AUBURNDALE	MA	02466	MIDDLESEX	USA	Cancer Detection and Diagnosis Research	002	3	8/29/2023	NON-COMPETING CONTINUATION	$997,685
2023	2021	GINER INC	89 RUMFORD AVE	AUBURNDALE	MA	02466	MIDDLESEX	USA	Cancer Detection and Diagnosis Research	001	2	5/1/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
2023	2019	GINER INC	89 RUMFORD AVE	AUBURNDALE	MA	02466	MIDDLESEX	USA	Cancer Detection and Diagnosis Research	000	1	3/13/2023	NEW	-$21,128
														Subtotal = $976,557

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	GINER, INC.	89 RUMFORD AVE	NEWTON	MA	02466	MIDDLESEX	USA	Cancer Detection and Diagnosis Research	000	2	8/19/2022	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $1,002,148 )
2021	2021	GINER, INC.	89 RUMFORD AVE	NEWTON	MA	02466	MIDDLESEX	USA	Cancer Detection and Diagnosis Research	001	2	9/3/2021	EXTENSION WITH OR WITHOUT FUNDS	$1,002,148
2021	2019	GINER, INC.	89 RUMFORD AVE	NEWTON	MA	02466	MIDDLESEX	USA	Cancer Detection and Diagnosis Research	000	1	5/10/2021	NEW	$0
														Subtotal = $1,002,148

Issue Date FY: 2019 ( Subtotal = $299,881 )
2019	2019	GINER, INC.	89 RUMFORD AVE	NEWTON	MA	02466	MIDDLESEX	USA	Cancer Detection and Diagnosis Research	000	1	9/16/2019	NEW	$299,881
														Subtotal = $299,881

Grand Total All Awards = $2,278,586

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Rapid, Multiplexed Biosensor for Non-Invasive Detection of Gene Mutations and Personalization of Therapy in Non-Small Cell Lung Cancer

Award Number: R44CA240021

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/17/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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