Analytical Validation of a Highly Quantitative, Sensitive, Accurate, and Reproducible Assay (HERmark®)‎ for the Measurement of HER2 Total Protein and HER2 Homodimers in FFPE Breast Cancer Tumor Specimens

Joint Authors

Huang, Weidong
Frankson, Kristi
Cook, Jennifer W.
Whitcomb, Jeannette M.
Winslow, John
Chen, Lili
Goodman, Laurie J.
Utter, Shannon
Parry, Gordon
Rivera, Amber
Irwin, Sarah
Larson, Jeffrey S.
Petropoulos, Christos J.
Bates, Michael
Cheung, Judy
Tan, Yuping
Defazio-Eli, Lisa
Shi, Yining
Sherwood, Thomas
Paquet, Agnes C.
Weidler, Jodi
Bose, Jolly
Kiss, Linda D. B.

Source

Pathology Research International

Issue

Vol. 2010, Issue 2010 (31 Dec. 2010), pp.1-14, 14 p.

Publisher

Hindawi Publishing Corporation

Publication Date

2010-06-28

Country of Publication

Egypt

No. of Pages

14

Main Subjects

Diseases
Medicine

Abstract EN

We report here the results of the analytical validation of assays that measure HER2 total protein (H2T) and HER2 homodimer (H2D) expression in Formalin Fixed Paraffin Embedded (FFPE) breast cancer tumors as well as cell line controls.

The assays are based on the VeraTag technology platform and are commercially available through a central CAP-accredited clinical reference laboratory.

The accuracy of H2T measurements spans a broad dynamic range (2-3 logs) as evaluated by comparison with cross-validating technologies.

The measurement of H2T expression demonstrates a sensitivity that is approximately 7–10 times greater than conventional immunohistochemistry (IHC) (HercepTest).

The HERmark assay is a quantitative assay that sensitively and reproducibly measures continuous H2T and H2D protein expression levels and therefore may have the potential to stratify patients more accurately with respect to response to HER2-targeted therapies than current methods which rely on semiquantitative protein measurements (IHC) or on indirect assessments of gene amplification (FISH).

American Psychological Association (APA)

Larson, Jeffrey S.& Goodman, Laurie J.& Tan, Yuping& Defazio-Eli, Lisa& Paquet, Agnes C.& Cook, Jennifer W.…[et al.]. 2010. Analytical Validation of a Highly Quantitative, Sensitive, Accurate, and Reproducible Assay (HERmark®) for the Measurement of HER2 Total Protein and HER2 Homodimers in FFPE Breast Cancer Tumor Specimens. Pathology Research International،Vol. 2010, no. 2010, pp.1-14.
https://search.emarefa.net/detail/BIM-500185

Modern Language Association (MLA)

Larson, Jeffrey S.…[et al.]. Analytical Validation of a Highly Quantitative, Sensitive, Accurate, and Reproducible Assay (HERmark®) for the Measurement of HER2 Total Protein and HER2 Homodimers in FFPE Breast Cancer Tumor Specimens. Pathology Research International No. 2010 (2010), pp.1-14.
https://search.emarefa.net/detail/BIM-500185

American Medical Association (AMA)

Larson, Jeffrey S.& Goodman, Laurie J.& Tan, Yuping& Defazio-Eli, Lisa& Paquet, Agnes C.& Cook, Jennifer W.…[et al.]. Analytical Validation of a Highly Quantitative, Sensitive, Accurate, and Reproducible Assay (HERmark®) for the Measurement of HER2 Total Protein and HER2 Homodimers in FFPE Breast Cancer Tumor Specimens. Pathology Research International. 2010. Vol. 2010, no. 2010, pp.1-14.
https://search.emarefa.net/detail/BIM-500185

Data Type

Journal Articles

Language

English

Notes

Includes bibliographical references

Record ID

BIM-500185