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Direct bioelectronic detection of SARS-CoV-2 from saliva using single-molecule field-effect transistor array

Award Number: R44DE030841
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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Direct bioelectronic detection of SARS-CoV-2 from saliva using single-molecule field-effect transistor array - Direct bioelectronic detection of SARS-CoV-2 from saliva using single-molecule field-effect transistor array Nucleic acid tests have become the gold-standard for diagnostic testing for COVID-19, usually performed in specialized laboratories. Most are based on reverse-transcription quantitative polymerase chain reaction (qRT-PCR). The time required for specimen transport and processing results in a turnaround time that is typi- cally several days. The few rapid (<1 hour) point-of-care (POC) tests are more expensive, still require sample preparation and specialized reagents, and do not have the throughput needed for population surveillance. Di- rect testing for the virus, which also reduces requirements for multiple reagents, is a necessary step to improv- ing diagnostic testing. While four such antigen tests have been approved for detection of SARS-CoV-2 based on immunoassays to the N protein, sensitivity is limited and no quantitation of viral load is possible. We will address this gap by using DiagnostikosTM, an in-development rapid POC platform for direct, real- time, multiplexed, quantitative bioelectronic detection of biomolecules that employs an all-electronic detection device that functions at the single-molecule level. These single-molecule field-effect transistors (smFETs) are arrayed on a complementary metal-oxide-semiconductor (CMOS) integrated circuit chip. Chips will interface with an envisioned USB-stick-form-factor reader device. Robust single-domain antibodies, known as nanobod- ies and immobilized on these devices, are used for sensitive detection of viral particles and viral debris. The use of multiple nanobodies for a single protein and nanobodies for different proteins in a single assay allows for significant improvements in specificity. Nanobodies will be specific for one or more of the four major struc- tural proteins in SARS-CoV-2; the nucleocapsid (N) protein engulfing the viral RNA, the spike (S) protein, the membrane (M) protein and the envelope (E) protein. No sample preparation or specialized reagents are re- quired for detection, and the device will be designed to operate with saliva, which has very recently been shown to be a reliable medium for detecting SARS-CoV-2. Individual sensor chips can be manufactured at a cost of $35. With the addition of other nanobodies, these large dense arrays can also allow detection of many pathogens in a single test. In this Direct-To-Phase-2 SBIR program we will pursue several key innovations that are required to make such a platform possible, including isolation of nanobodies for key structure proteins of SARS-CoV-2 (Specific Aim 1), development of the smFET platform for antigen detection (Specific Aim 2), development of large CMOS arrays of these smFET devices (Specific Aim 3), and verification of detection in increasingly complex samples up to and including clinical samples (Specific Aim 4). This project is a partnership between university researchers who developed the smFET technology and a venture-based start-up venture, Quicksilver Biosci- ences, spun out to commercialize smFET technology and develop smFET/CMOS arrays for molecular diag- nostic applications.


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	QUICKSILVER BIOSCIENCES INC	1361 AMSTERDAM AVE	NEW YORK	NY	10027	NEW YORK	USA	Trans-NIH Research Support	000	2	5/27/2025	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	QUICKSILVER BIOSCIENCES INC	1361 AMSTERDAM AVE	NEW YORK	NY	10027	NEW YORK	USA	Trans-NIH Research Support	001	2	5/20/2024	EXTENSION WITH OR WITHOUT FUNDS	$0
2024	2022	QUICKSILVER BIOSCIENCES INC	1361 AMSTERDAM AVE	NEW YORK	NY	10027	NEW YORK	USA	Trans-NIH Research Support	000	2	11/9/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	QUICKSILVER BIOSCIENCES INC	1361 AMSTERDAM AVE	NEW YORK	NY	10027	NEW YORK	USA	Trans-NIH Research Support	001	2	9/14/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
2023	2021	QUICKSILVER BIOSCIENCES INC	1361 AMSTERDAM AVE	NEW YORK	NY	10027	NEW YORK	USA	Trans-NIH Research Support	000	1	9/14/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $447,801 )
2022	2022	QUICKSILVER BIOSCIENCES, INC.	1361 AMSTERDAM AVE STE 340	NEW YORK	NY	10027	NEW YORK	USA	Trans-NIH Research Support	000	2	2/10/2022	EXTENSION WITH OR WITHOUT FUNDS	$447,801
2022	2021	QUICKSILVER BIOSCIENCES, INC.	1361 AMSTERDAM AVE STE 340	NEW YORK	NY	10027	NEW YORK	USA	Trans-NIH Research Support	001	1	4/20/2022	NEW	$0
														Subtotal = $447,801

Issue Date FY: 2021 ( Subtotal = $817,335 )
2021	2021	QUICKSILVER BIOSCIENCES, INC.	1361 AMSTERDAM AVE STE 340	NEW YORK	NY	10027	NEW YORK	USA	Trans-NIH Research Support	001	1	3/15/2021	NEW	$0
2021	2021	QUICKSILVER BIOSCIENCES, INC.	1361 AMSTERDAM AVE STE 340	NEW YORK	NY	10027	NEW YORK	USA	Trans-NIH Research Support	000	1	12/21/2020	NEW	$817,335
														Subtotal = $817,335

Grand Total All Awards = $1,265,136

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Direct bioelectronic detection of SARS-CoV-2 from saliva using single-molecule field-effect transistor array

Award Number: R44DE030841

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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