Peer Review Panel
Independent Scientific Peer Review Panel Report: Evaluation of the LUMI-CELL ER®
(BG1Luc ER TA) Test Method - May 2011 [PDF]
Corrections to the Peer Review Panel Report (August 2011) [PDF]
This document lists changes made to the report by the peer review panel members that were inadvertently omitted
in the printed version of the report. The electronic version of the report available above includes
these corrections. If you have a printed copy of this report, please print this document and
keep it with the printed report. We apologize for any inconvenience.
Read a summary of the March 29-30 Peer Review Panel meeting
[PDF]
See below for documents reviewed by the Peer Review Panel
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In a March 2011 public meeting, an independent international peer review panel agreed with ICCVAM
draft test method recommendations stating that an in vitro test method may be used as an initial
screen to identify substances with the potential to enhance or inhibit activation of the estrogen
receptor. NICEATM and ICCVAM convened the peer review panel meeting on March 29-30, 2011 at the
William H. Natcher Center, on the NIH campus in Bethesda, MD.
The panel of 16 expert scientists from six countries reviewed data from a NICEATM-sponsored
validation study to assess the accuracy and reliability of an in vitro test method that uses human
ovarian cancer cells to predict whether a substance might enhance or inhibit normal estrogen
function. Substances with such properties are often referred to as endocrine active substances. The
Panel also made recommendations on future studies that could further enhance the usefulness of this
test method, and commented on draft performance standards that could be used to expedite the
evaluation of similar test methods.
Studies have indicated that animal populations exposed to high levels of endocrine active
substances have an increased incidence of reproductive and developmental abnormalities. These
findings have raised concerns about the potential public health and environmental effects of these
substances. Accordingly, the EPA initiated the Endocrine Disruptor Screening Program to screen
pesticides and environmental contaminants for their potential to affect the endocrine systems of
humans and wildlife. The test method reviewed by the panel, LUMI-CELL® BG1Luc ER TA, may be
appropriate for use as an initial screen of substances tested in this program. The LUMI-CELL® test
method was developed by Xenobiotic Detection Systems, Inc., with support from a Small Business
Innovation Research grant from NIEHS.
View more information about the validation study of the BG1Luc ER TA test method
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View agenda for the public Peer Review Panel meeting
[PDF]
Federal Register Notices
Independent Scientific Peer Review Panel Report: Evaluation of the Validation
Status of an In Vitro Estrogen Receptor Transcriptional Activation Test Method
for Endocrine Disruptor Chemical Screening: Notice of Availability and Request
for Public Comments (76 FR 28781, May 18, 2011)
[PDF]
Independent Scientific Peer Review Panel Meeting on an
In Vitro Estrogen Receptor Transcriptional Activation Test
Method for Endocrine Disruptor Chemical Screening; Availability
of Draft Background Review Document; Request for Comments
(76 FR 4113, January 24, 2011) [PDF]
Draft Documents Reviewed by the Peer Review Panel
Please note:
- These are draft documents provided as part of the public record of the Peer Review
Panel meeting. The final ICCVAM recommendations, performance standards, protocols, and
background review documents are available on the test method evaluation report page.
- Draft documents may not be completely accessible to those using
assistive technologies. Contact the NICEATM webmaster if
you need assistance accessing any of the documents linked below.
Draft ICCVAM Test Method Recommendations for the BG1Luc ER TA Test Method
[PDF]
Draft ICCVAM Test Method Performance Standards
- Main Body and Appendix A: ICCVAM Recommended Substances [PDF]
Please note: Data in Figures 1 and 2 of the original draft Performance Standards illustrated generalized
curves of agonist and antagonist responses, but were not actual examples of curves generated during the validation study. These
figures are being replaced with graphs of data produced during the BG1Luc validation study.
- Appendix B: BG1Luc ER TA – Agonist Protocol [PDF]
- Appendix C: BG1Luc ER TA – Antagonist Protocol [PDF]
Background Review Document
Front Matter [PDF]
Includes Table of Contents, Acknowledgements, Preface and Executive Summary
Section 1: Introduction [PDF]
Section 2: BG1Luc ER TA Test Method Protocol Components [PDF]
Section 3: Substances Used for the Validation of the BG1Luc ER TA Test Method
[PDF]
Section 4: Test Method Data and Results [PDF]
Section 5: Accuracy of the BG1Luc ER TA Test Method [PDF]
Section 6: Test Method Reliability [PDF]
Section 7: BG1Luc ER TA Data Quality [PDF]
Section 8: Other Scientific Reports [PDF]
Section 9: Animal Welfare Considerations (Refinement, Reduction, and Replacement) [PDF]
Section 10: Practical Considerations [PDF]
Section 11: References [PDF]
Section 12: Glossary [PDF]
Background Review Document Annexes
Annex A: XDS Submission Data
- Main Body and Appendix A [PDF]
- Appendix B: Characterization of Substances Tested [PDF]
- Appendix C: Representative 17β-estradiol Curve [PDF]
- Appendix D:
- Agonist Plate-to-Plate Data Summary [PDF]
- Plate-to-Plate Agonist Raw Data [XLS]
- Appendix E:
- Antagonist Plate-to-Plate Data Summary [PDF]
- Plate-to-Plate Antagonist Raw Data [XLS]
- Appendix F:
- Well-to-Well Agonist Data Summary [PDF]
- Well-to-Well Agonist Raw Data [XLS]
- Appendix G:
- QC Charts [PDF]
- QC Performance Charts [XLS]
Annex B: NICEATM Evaluation
[PDF]
Annex C: NICEATM Report on the XDS Protocol Standardization
- Main Body and Appendix A [PDF]
- Appendices B and C: BG1Luc ER TA Initial Protocols [PDF]
Annex D: NICEATM Addendum to ICCVAM Evaluation of In Vitro Test Methods for Detecting Potential Endocrine Disruptors:
Estrogen Receptor and Androgen Receptor Binding and Transcriptional Activation Assays
(NIH Publication No: 03-4503) [PDF]
Annex E: BG1Luc ER TA Agonist Protocol [PDF]
Annex F: BG1Luc ER TA Antagonist Protocol [PDF]
Annex G: Materials Relating to Cell Viability
- Annex G1: Cell Viability Manual
[PDF]
- Annex G2: Cell Viability Assessments - Qualitative versus Quantitative Assessment
[PDF]
- Annex G3: BG1Luc Viability Tables [PDF]
Annex H: Validation Study Documents
- Annex H1: Validation Work Plan [PDF]
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Annex H2: GLP Compliance Statement [PDF]
Annex I: Substances Used for the Validation of the BG1Luc ER TA Test Method
- Annex I1: ICCVAM Recommended Substances – Structures, Chemical, and Product Class
[PDF]
- Annex I2: Substances used during BG1Luc ER TA Validation – Purity and Supplier Information
[PDF]
- Annex I3: Substances used during BG1Luc ER TA Validation – Test Substance Codes
[PDF]
Annex J: ICCVAM/NICEATM BG1Luc ER TA – Prism Files: Prism Files for All Validation Study Phases
[PDF]
Annex K: Experimental Details
- Annex K1: List of Test Substance Ship and Test Dates [PDF]
- Annex K2: Phase 1 Experiments Conducted to Establish Historical Databases
[PDF]
- Annex K3: Phase 2a List of All Experiments
[PDF]
- Annex K4: Phase 2b List of All Experiments
[PDF]
- Annex K5: Phase 3 List of All Experiments
[PDF]
- Annex K6: Phase 4 List of All Experiments
[PDF]
Annex L: Within Plate DMSO Control Values for BG1Luc ER TA Agonist and Antagonist Assays
[PDF]
Annex M: Plate Redesign and the Compilation of an Historical Database
[PDF]
Annex N: Literature Update Files
- Annex N1: Binding Data from the Scientific Literature
[XLS]
- Annex N2: ER TA Data from the Scientific Literature
[XLS]
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Annex N3: References for Annexes N1 and N2
[PDF]
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