You are here

Next Generation Testing Strategies for Assessment of Genotoxicity

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44ES029014-01
Agency Tracking Number: R44ES029014
Amount: $178,854.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 113
Solicitation Number: PA16-302
Solicitation Year: 2016
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-03-01
Award End Date (Contract End Date): 2018-11-30
Small Business Information
Rochester, NY 14623-2860
United States
DUNS: 085992055
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (585) 442-0930
Business Contact
Phone: (585) 489-0256
Research Institution

Project SummaryIt is well recognized that current batteries of genetic toxicology assays exhibit two critical deficienciesFirstthe throughput capacity of in vitro mammalian cell genotoxicity tests is lowand does not meet current
needsSecondconventional assays provide simplistic binary callsgenotoxic or non genotoxicIn this scheme
there is little or no consideration for potencyand virtually no information is provided about molecular targets
and mechanismsThese deficiencies in hazard characterization prevent genotoxicity data from optimally
contributing to modern risk assessmentswhere this information is essentialWe will address these major
problems with current in vitro mammalian cell genetic toxicity assays by developing methods and associated
commercial assay kits that dramatically enhance throughput capacityand delineate genotoxicantsandaposprimary
molecular targetswhile simultaneously providing information about potencyOnce biomarkers and a family of
multiplexed assays have been developed for these purposesan interlaboratory trial will be performed with
prototype assay kits to assess the transferability of the methods Project NarrativeDNA damage that cannot be faithfully repaired results in gene mutation and or chromosomal
aberrationsand these effects are known to contribute to cancer and other severe diseasesThusthere is an
important need for sensitive assays to evaluate chemicals for genotoxic and other deleterious effectsThe
work proposed herein will address issues that have plagued genotoxicity assessments for the last several
decadeslow throughputlack of potency metricsand little to no information about molecular targetsWe will
address these major problems with current genetic toxicity assays by developing new methods and associated
commercial assay kits

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

US Flag An Official Website of the United States Government