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NGS based metagenomic screening of ocular infections

Award Number: R42EY033266
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2022
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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NGS based metagenomic screening of ocular infections - Project Summary/Abstract: The project objective is to develop an organism-agnostic deep sequencing-based diagnosis of ocular infectious disease from microliter-sized biopsies in less than 24 hours and for less than $1000. Current diagnostic approach relies on bacterial and fungal cultures that are time-consuming (~2-3 days) and often leads to the overuse of broad-spectrum antibiotics. In Phase I, we successfully developed and validated the EYE-Path™ system, demonstrating an integrated Scalable Metagenomics Alignment Research Tool (SMART) with an automated DNA extraction system for sample preparation. This system achieved a low limit of detection (104 cells/mL) and a turnaround time of <3 hours for bacterial infections. In Phase II, we plan to optimize the adaptive sequencing software for the SMART Adapt algorithm, validate the system in a multi-site clinical study (University of California, Los Angeles and University of Washington) in patients with corneal ulcer and suspected endophthalmitis, validate the system as a CLIA ready test and initiate a pre-submission meeting with the FDA to determine the appropriate regulatory strategy for eye-PATH to be considered as a CLIA waived in vitro-diagnostic device. The success completion of this project could significantly impact ocular infection diagnosis and treatment planning, with broader applications in point-of-care devices and non-ophthalmic diagnostics, helping to combat antimicrobial resistance.


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: 2024 ( Subtotal = $803,560 )
2024	2024	CHROMOLOGIC LLC	1225 S SHAMROCK AVE	MONROVIA	CA	91016	LOS ANGELES	USA	Vision Research	000	2	9/12/2024	COMPETING CONTINUATION	$803,560
														Subtotal = $803,560

Grand Total All Awards = $803,560

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NGS based metagenomic screening of ocular infections

Award Number: R42EY033266

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/01/2022

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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