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A multimodal platform for Oral screening of COVID-19

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R42DE030829-01
Agency Tracking Number: R42DE030829
Amount: $755,999.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIDCR
Solicitation Number: PA20-272
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2020-12-21
Award End Date (Contract End Date): 2023-11-30
Small Business Information
Boston, MA 02130-2403
United States
DUNS: 128900562
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (617) 372-2141
Business Contact
Phone: (617) 372-2141
Research Institution
255 MAIN STREET NE18-901
CAMBRIDGE, MA 02142-1029
United States

 Nonprofit College or University

Original Abstract
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.For preparedness for future pandemics there is an urgent need for the expedited development of
diagnostics to new pathogens for rapid, accurate, and field deployable diagnostic tests for timely
management of an outbreak. Thus, our innovative platform for expedited development of accurate
and low-cost diagnostics on-site from easily collectible oral specimens is essential for the
successful management of infectious diseases.

* Information listed above is at the time of submission. *

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