Interlaboratory Validation of an Exogenous Metabolic Activation System for FETAX

Period of Performance: 12/08/1997 - 12/08/1999

$461K

Phase 2 SBIR

Recipient Firm

Stover & Assoc., Inc.
5302 West 6th
Stillwater, OK 74075
Principal Investigator

Research Topics

Abstract

Frog Embryo Teratogenesis Assay - Xenopus (FETAX) is a 96-hour, whole embryo bioassay designed to detect potential developmental toxicants. Because young Xenopus embryos are virtually incapable of biotransforming compounds during the FETAX assay, an exogenous metabolic activation system (MAS) is required to increase the predictive accuracy and overall versatility of the assay to screen for developmental toxicants which pose a potential hazard to human health. Preliminary studies have suggested that the inclusion of this system has increased the predictive accuracy of FETAX from approximately 83% to >95% at this point. The objective of the proposed project is to interlaboratory validate the exogenous MAS which was developed and standardized in Phase I studies. Furthermore, the second objective will be to demonstrate the utility of FETAX as an alternative method of rapidly identifying developmental toxicants. The effort involved will include a three-tiered, two year validation program conduced in three separate laboratories. The validation program will be initiated with a training tier and conclude with the testing of a series of test materials under a real-world setting (blind testing). The anticipated benefits of this research will be to develop an alternative assay which could not only be used by the U.S. Army, but also the private sector (industries) and regulatory arena, to effectively screen for human-related developmental toxicants in the environment. BENEFITS: The FETAX test may be easily commercialized and used by most environmental and biomedical testing laboratories across the U.S. Industries producing drugs and chemicals can quickly screen their products for developmental toxicity and save considerable amounts of time and money once this test has been validated. Use of FETAX will enable the U.S. Army to evaluate potential developmental toxicity hazards both in the field and work place in a rapid, cost-effective manner.