NICEATM coordinated an international interlaboratory validation study of the BG1Luc ER TA (LUMI-CELL®) test method developed by Xenobiotic Detection Systems, Inc. The study included three laboratories sponsored by NICEATM, the European Centre for the Validation of Alternative Methods, and the Japanese Center for the Validation of Alternative Methods. The goal of the validation study was to evaluate the usefulness of the BG1Luc ER TA test method as a screening test to identify substances with in vitro estrogen receptor (ER) agonist and antagonist activity.
The validation study of the BG1Luc ER TA test method has been completed and was the subject of a 2011 peer review by an ICCVAM-sponsored independent peer review panel. Following the recommendations of the independent peer review panel, ICCVAM recommends that the BG1Luc ER TA test method may be used as a screening test to identify substances with in vitro estrogen receptor agonist and/or antagonist activity. The ICCVAM recommendations to be transmitted to Federal agencies include recommendations on performance standards for the expedited validation of functionally and mechanistically similar test methods.