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NICEATM coordinated an international interlaboratory validation study of a MCF-7 cell
proliferation test method developed by CertiChem, Inc. (CertiChem) for the detection of estrogenic activity.
The international validation study included participating laboratories located in the
U.S., Japan, and Korea. It was sponsored jointly by ICCVAM, the Japanese Center for the
Validation of Alternative Methods, and the Korean Center for the Validation of Alternative Methods.
The validation study was completed in 2011. Results from the study are currently being evaluated
to determine the usefulness and limitations of the test method.
Background
The MCF-7 cell proliferation test method was developed by CertiChem in collaboration with laboratories
at the University of Missouri and Northwestern University. It was further refined
by CertiChem with the support of NIH Phase I and II Small Business Innovation
Research (SBIR) grants awarded in 2001 and 2004 respectively. The test method uses MCF-7 WS8 cells to measure
whether and to what extent a substance induces cell proliferation via estrogen receptor (ER)-mediated pathways.
MCF-7 WS8 cells are a subclone of the MCF-7 cell line, an immortalized human breast adenocarcinoma cell line
that endogenously expresses both human ER forms, ERα and ERβ.
The specific objectives of the validation study of the CertiChem MCF-7 cell proliferation test method were to:
- Optimize the test method using agonist and antagonist protocols to
test the 78 ICCVAM recommended substances for the validation of in vitro ER transcriptional activation
(TA) test methods in three
laboratories to maximize test method reliability (intralaboratory repeatability, intra- and
inter-laboratory reproducibility)
- Use the results from the testing of the 78 ICCVAM recommended substances to develop a high
quality in vitro ER TA database that can be used to characterize the extent to which other
individual in vitro endocrine disruptor test methods (or test method batteries) might be used to
further reduce the expected requirements for animal use in the screening of potential endocrine
disruptors
Presentation at the 2011 Society of Toxicology Meeting
NICEATM staff and international collaborators presented an update on the international validation study
of the MCF-7 cell proliferation test method
at the 2011 meeting of the Society of Toxicology.
"International Validation Study of an In Vitro Cell
Proliferation Test Method for Screening Potential Estrogenic Agonists and Antagonists in MCF-7
Cells"
F Deal, W Casey, P Ceger, D Allen, C Yang, M Nakamura, H Kojima, A Ono, H Yoon, S Han, W Stokes
View abstract [PDF]
View poster [PDF]
View all ICCVAM posters presented at the 2011 SOT meeting
Related Documents
Test Method Nomination for the MCF-7 Cell Proliferation Assay of Estrogenic Activity (January 2006) [PDF]
NICEATM Pre-Screen Evaluation of the In Vitro Endocrine Disruptor Assay
(Robotic MCF-7 Cell Proliferation Assay of Estrogenic Activity) (October 2006) [PDF]
Federal Register notice announcing the availability of the Pre-Screen Evaluation
(71 FR 60748, October 16, 2006)
[PDF]
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