HER2 homodimer and HER2 total protein assays validated.
Monogram monogram [Gr.,=single letter], symbol of a name or names, consisting typically of a letter or several letters worked together. A famous monogram is that of Christ, consisting of X (chi) and P (rho), the first two letters of Christ in Greek. Biosciences, Inc. (South San Francisco South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , CA) presented the results of a study detailing the HERmark Assay's ability to identify metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.
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pertaining to or of the nature of a metastasis. breast cancer patients who are most likely to respond to Herceptin. The study results were presented this week at the San Antonio San Antonio (săn ăntō`nēō, əntōn`), city (1990 pop. 935,933), seat of Bexar co., S central Tex., at the source of the San Antonio River; inc. 1837. Breast Cancer Symposium. Also this week, Monogram received confirmation from the College of Pathologists that the HERmark assays are approved for routine patient testing in Monogram's CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a certified clinical reference laboratory.
"The results are an important step along the way to clinical validation of HERmark, the first product based on the VeraTag technology platform," said William Young William Young may refer to:
In the study, Monogram analyzed tissue samples from patients with metastatic breast cancer who were treated with Herceptin, having been selected for such treatment by centralized cen·tral·ize
v. cen·tral·ized, cen·tral·iz·ing, cen·tral·iz·es
1. To draw into or toward a center; consolidate.
2. IHC IHC Immunohistochemistry
IHC Intermountain Health Care
IHC Inner Hair Cells
IHC International Harvester Company
IHC Internet Healthcare Coalition
IHC Indian Head Cent
IHC Interactive Health Communication
IHC International Hurricane Center testing. While current testing methods identified all these patients as being appropriate for Herceptin treatment, Monogram's HERmark Assay was able to distinguish separate sub-populations of patients with different clinical outcomes.
Patients with higher HER2 expression levels (i.e. in the upper half of the distribution for the study cohort) experienced a 59% objective response rate while those with lower levels of HER2 expression (i.e. in the lower half of the distribution) had a response rate of only 18%. Additional analyses revealed that patients with higher HER2 expression values had a median time-to-progression of 12.8 months while those in the lower half of the distribution had a median time-to-progression of only 4 months. This result was statistically significant (p = 0.01). Finally, multivariate Cox proportional hazards models General
Proportional hazards models are a sub-class of survival models in statistics.
For the purposes of this article, consider survival models to consist of two parts: the underlying hazard function, describing how hazard (risk) changes over time, and the effect identified HER2 expression (HR = 0.16, p < 0.001) and HER2:HER2 dimer dimer /di·mer/ (di´mer)
1. a compound formed by combination of two identical molecules.
2. a capsomer having two structural subunits.
1. levels (HR = 0.32, p < 0.001) as measured by HERmark as being statistically significant predictors of time-to-progression.
"Current testing technologies do not provide an accurate or precise view of HER2 biology in breast cancer, classifying patients as either HER2 'positive' or HER2 'negative'," continued Young. "At best, conventional technologies provide a semi-quantitative analysis. However, only about half of metastatic patients selected by current technologies for Herceptin treatment respond to the drug. Data are now emerging to suggest that patients who could benefit from Herceptin may be missed by currently used assays. Our HERmark studies have provided data which consistently indicate that HERmark can precisely measure HER2 expression and HER2:HER2 dimer levels in clinical FFPE FFPE Formalin-Fixed, Paraffin-Embedded (tissue)
FFPE Fédération de la Fonction Publique Européenne (Staff Representation at the European Commission) samples, and that those patients with higher levels of expression have significantly better clinical outcomes than those with lower levels. These data strongly suggest that HERmark can identify patients who are likely to respond to Herceptin better than the assays currently in use." HERmark Assay in Metastatic Breast Cancer
At ASCO ASCO American Society of Clinical Oncology
ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland)
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ASCO Automatic Switch Company in June 2007, Monogram reported results of studies of HERmark in two patient cohorts. In the first of these studies, it was demonstrated that within a population of patients that were stringently selected by FISH testing, the HERmark assay was able to measure a gradient of HER2 expression and HER2 homodimer levels that was significantly correlated with time-to-progression and overall survival on Herceptin. In the second metastatic patient cohort presented at ASCO, selected by IHC in a clinic-based setting, the HERmark assay was also able to demonstrate that patients who were confirmed HER2 positive by IHC on repeat testing showed a gradient of response, and that those with higher levels of HER2 expression and HER2 homodimer levels as measured by HERmark lived longer than those who had lower levels. The results of these two previously reported cohorts, along with the third cohort presented, provide the basis for Monogram's ongoing work in metastatic breast cancer. There are approximately 60,000 women annually in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. who are newly diagnosed with Stage IV breast cancer or who have progressed from earlier stages of disease. These are patients for whom the cancer has spread beyond the breast, and in many cases multiple treatments may have already been provided.
Monogram has initiated a study with one of the leading oncology clinical trial cooperative groups in the country. In this ongoing study, we are performing HERmark assays on tissue samples from up to 1,600 breast cancer patients treated with Herceptin in the adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant)
1. assisting or aiding.
2. a substance that aids another, such as an auxiliary remedy.
3. setting. The goal of the study is to clinically validate the ability of HERmark to predict clinical outcome in these Herceptin-treated patients. These patients are generally newly diagnosed with breast cancer, have had surgery and are now on a first course of treatment to supplement the surgical procedure. In the United States, there are approximately 200,000 new cases of breast cancer each year, most of whom are candidates for adjuvant treatment and therefore would be candidates for the HERmark adjuvant breast cancer assay.
HERmark is a proprietary diagnostic that accurately quantifies HER2 expression and dimerization in patients with breast cancer. Preliminary data from three cohorts of Herceptin-treated patients with metastatic breast cancer who were identified as "HER2 positive" by conventional assays suggest that HERmark can identify patients who are likely to respond to Herceptin with greater precision than currently available tests, permitting stratification of patients according to according to
1. As stated or indicated by; on the authority of: according to historians.
2. In keeping with: according to instructions.
3. their degree of clinical benefit from the drug. Additional studies of HERmark for breast cancer in both the metastatic and adjuvant settings are in progress.
VeraTag is a proximity-based assay technology platform that accurately quantifies proteins and functional protein complexes. This platform provides a researcher or clinician a more thorough understanding of protein-protein interactions or signaling pathway activity allowing for disease characterization at the molecular level. VeraTag is designed to run on standard formalin-fixed paraffin embedded patient samples.
Monogram is advancing individualized in·di·vid·u·al·ize
tr.v. in·di·vid·u·al·ized, in·di·vid·u·al·iz·ing, in·di·vid·u·al·iz·es
1. To give individuality to.
2. To consider or treat individually; particularize.
3. medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases infectious diseases: see communicable diseases. and cancer. The company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The company's technology is also being used by numerous biopharmaceutical companies to develop new and improved anti-viral therapeutics and vaccines as well as targeted cancer therapeutics.
Monogram Biosciences, Inc.