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A multimodal platform for Oral screening of COVID-19

Award Number: R42DE030829
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/21/2020
PERIOD OF PERFORMANCE END DATE: 11/30/2024

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A multimodal platform for Oral screening of COVID-19 - The development of a rapid and reliable sensor system from readily available oral specimens is crucial for the screening and management of SARS-CoV-2 infection. Other than tests that require laboratory-scale instrumentation, the development of rapid tests can play a timely role in the management of an outbreak. Current rapid tests often involve the antibodies in a lateral flow format to detect viral protein components and, depending on the implementation, can result in a relatively high degree of error. In partnership with MIT, InnoTech proposes the development of a multiplexed sensor platform based on nanomaterials capable of molecular binding and subsequent reporting. We will develop and commercialize a multiplexed sensor platform using nanomaterial reporters capable of rapid simultaneous detection of multiple components of viral particles in a field applicable electrochemical device. For our Phase I- Aim 1 we will focus on the development and optimization of synthetic biosensors for accurate detection of SARS-CoV-2 viral proteins and nucleic acid. Our milestone is the discovery and validation an array of molecular recognition biosensors against both protein and nucleic acid segments of SARS-CoV-2. We will complete this phase in 4 months. In Phase II-Aim 1, we will develop and validate the electrochemical detectors. We will utilize the synthetic biosensors identified and validated in Aim 1 to an electrochemical platform for the rapid detection of an active SARS-CoV-2 infection using multiple biomarkers of the infection. We will specifically employ commercially-available, disposable electrode platforms and existing potentiostats from Metrohm DropSens to streamline scale-up and commercialization. Our milestone, to be completed in year 1 of Phase II, is to have a multiplex biosensor chip and an alpha prototype with a multiplex biosensor chip and a potentiostat reader which we will benchmark for sensitivity and quantitative accuracy against existing COVID-19 diagnostics. In Phase II-Aim 2, we will validate the prototype chips and detectors with retrospective clinical specimens in preparation for EUA-FDA submission. We will determine the LOD, clinical performance, and cross-reactivity with other respiratory pathogens and normal flora. The milestone for this Aim is to document a multiplex of at least two proteins and two nucleic acid biosensors for SARS-CoV-2 that will provide a LOD of 5-20 viruses per microliter in an oral specimen and will be clinically validated with greater than 95% concordance with RT-PCR in 30 positive and 30 negative specimens.


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	2022	INNOTECH PRECISION MEDICINE, INC	11 PARKSIDE DR	JAMAICA PLAIN	MA	02130	SUFFOLK	USA	Trans-NIH Research Support	000	1	1/30/2025	SUPPLEMENT FOR EXPANSION	$0
2025	2021	INNOTECH PRECISION MEDICINE, INC	11 PARKSIDE DR	JAMAICA PLAIN	MA	02130	SUFFOLK	USA	Trans-NIH Research Support	001	1	4/16/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	INNOTECH PRECISION MEDICINE, INC	11 PARKSIDE DR	JAMAICA PLAIN	MA	02130	SUFFOLK	USA	Trans-NIH Research Support	001	1	10/23/2023	SUPPLEMENT FOR EXPANSION	$0
2024	2021	INNOTECH PRECISION MEDICINE, INC	11 PARKSIDE DR	JAMAICA PLAIN	MA	02130	SUFFOLK	USA	Trans-NIH Research Support	000	1	10/23/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $500,000 )
2022	2022	INNOTECH PRECISION MEDICINE, INC.	11 PARKSIDE DR	BOSTON	MA	02130	SUFFOLK	USA	Trans-NIH Research Support	002	1	9/27/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2022	INNOTECH PRECISION MEDICINE, INC.	11 PARKSIDE DR	BOSTON	MA	02130	SUFFOLK	USA	Trans-NIH Research Support	000	1	8/31/2022	SUPPLEMENT FOR EXPANSION	$500,000
2022	2021	INNOTECH PRECISION MEDICINE, INC.	11 PARKSIDE DR	BOSTON	MA	02130	SUFFOLK	USA	Trans-NIH Research Support	001	1	9/27/2022	NEW	$0
														Subtotal = $500,000

Issue Date FY: 2021 ( Subtotal = $255,999 )
2021	2021	INNOTECH LLC	11 PARKSIDE DR	BOSTON	MA	02130	SUFFOLK	USA	Trans-NIH Research Support	000	1	12/21/2020	NEW	$255,999
														Subtotal = $255,999

Grand Total All Awards = $755,999

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A multimodal platform for Oral screening of COVID-19

Award Number: R42DE030829

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 12/21/2020

PERIOD OF PERFORMANCE END DATE: 11/30/2024

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