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Functional Read-Out Enabling High Compound Throughput Toxicokinetic Assays

Award Number: R43ES032368
ORGANIZATION: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/11/2020
PERIOD OF PERFORMANCE END DATE: 01/31/2022

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Functional Read-Out Enabling High Compound Throughput Toxicokinetic Assays - Summary: This Phase I project will implement and demonstrate the feasibility and utility of a new “universal” assay readout to provide high throughput in vitro toxicokinetics (HTTK) data without having to develop specific analytical methods to measure each compound. The amount of available compound from standard in vitro toxicokinetic modes of plasma binding, metabolic clearance, and bidirectional permeability will be quantified using the microplate-based TempO-Seq® gene expression platform, the S1500+v2 surrogate whole transcriptome assay which measures every known molecular pathway, and a HepaRG cell system to first identify a gene expression signature that is characteristic of each test compound and generate dose response data, then use this and benchmark concentration (BMC) analysis of signature genes and pathways as a calibration curve to quantify the amount of compound available from each in vitro toxicokinetic model. The in vitro TempO-Seq HTTK data will also identify potential safety issues and provide data useful for read-across comparisons, making the assay highly efficient by providing both the in vitro safety and in vitro toxicokinetic data necessary to make in vitro-to-in vivo extrapolations (IVIVE) and prioritize compounds for follow-up based on exposure safety risk. Reference compounds will be tested and we will benchmark the TempO-Seq HTTK data against published data obtained using analytical methods, and also demonstrate that TempO-Seq HTTK results are equivalent to IVIVE results determined using analytical methods. Unlike a functional assay using a single endpoint specific for the compound being measured, the TempO-Seq S1500v2 assay has been shown by numerous labs to provide a signature of many robustly differentially expressed genes for all compounds tested to-date, unique for each compound. Thus, this content represents a “universal” assay for any test compound or mixture (e.g. as produced in industrial chemical processes), producing compound specific signatures for use in the TempO-Seq HTTK assay. By enabling the high throughput in vitro assessment of toxicokinetics of thousands of compounds, the TempO-Seq HTTK assay will enable programs such as ToxCast to achieve the objective of providing IVIVE assessment of the tens of thousands of compounds humans and the environment are exposed to for which there are no safety data. It will also provide the pharma, agricultural, cosmetics, and petroleum/chemical industries comparative in vitro toxicity and toxicokinetic data supporting IVIVE analysis to assist synthetic chemists in design and development decisions for advancing chemical series and leads or protection of employees from exposure, and has the potential to spare animals by preselecting the compounds put into animal models.


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: 2022 ( Subtotal = $0 )
2022	2020	BIOSPYDER TECHNOLOGIES, INC.	5928 PASCAL CT STE 100	CARLSBAD	CA	92008	SAN DIEGO	USA	Environmental Health	000	1	8/17/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $224,980 )
2020	2020	BIOSPYDER TECHNOLOGIES, INC.	5922 FARNSWORTH CT STE 102	CARLSBAD	CA	92008	SAN DIEGO	USA	Environmental Health	000	1	8/11/2020	NEW	$224,980
														Subtotal = $224,980

Grand Total All Awards = $224,980

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Functional Read-Out Enabling High Compound Throughput Toxicokinetic Assays

Award Number: R43ES032368

ORGANIZATION: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/11/2020

PERIOD OF PERFORMANCE END DATE: 01/31/2022

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