HER1 and HER3 VeraTag™ Assays now Available for Use in Clinical Evaluation of Cancer Therapeutics
Product News May 02, 2008
Monogram Biosciences, Inc. has announced that the company's HER1 and HER3 Quantitative Protein Assays are now available for clinical development use.
Built on Monogram's VeraTag™ platform, the HER1 and HER3 assays provide quantitative measurements of protein expression and activity in formalin fixed paraffin embedded (FFPE) tumor samples. These assays supplement HERmark™, Monogram's HER2 and HER2:HER2 Homodimer Breast Cancer Assay, and expands the potential clinical reach of Monogram's VeraTag assays to lung, colorectal and other cancers.
"We are excited to make the HER1 and HER3 assays available for clinical development use," said William Young, president and CEO of Monogram Biosciences.
"Our first VeraTag product, HERmark, is already available for use in clinical development programs through our CLIA-approved laboratory and provides quantitative and accurate measurements of the expression of HER2 and HER2:HER2 homodimers. The addition of the HER1 and HER3 assays expands the reach of our VeraTag technology and we look forward to forging collaborations with biopharmaceutical companies to advance the use of our diagnostics and enable the development of new treatment options for those living with cancer,” Young added.
"Oncologists have long known about the role that HER2 plays in breast cancer and, although far from perfect, have had some tools available to measure it," said Michael Bates, M.D., Monogram vice president of clinical research. "Accurate, quantitative measurements for EGFR (HER1) and HER3 have never before been available and are badly needed to help unravel the complex biology of cancer and enable the development and clinical use of targeted cancer therapies."
"Our HER1 and HER3 assays provide accurate, precise and highly reproducible measurements of these key analytes with sensitivity more than five times that of routinely performed IHC testing," said Gordon Parry, Ph.D., Monogram vice president of research & development, oncology. "Making these measurements in FFPE tissue is particularly important as this is the standard fixation and storage method in most pathology laboratories."
Monogram has a growing portfolio of VeraTag assays that measure proteins, protein complexes and post-translational modifications such as phosphorylation, in FFPE tumor samples and can aide cancer drug development and clinical evaluation. The HERmark Assay is validated according to CAP/CLIA regulations for routine testing in our CLIA-approved clinical reference laboratory and provides measurements of HER2 and HER2:HER2 homodimers.