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Monogram and Dana-Farber Cancer Institute Initiate Evaluation of HERmark(TM) Breast Cancer Assay in Metastatic Breast Cancer

SOUTH SAN FRANCISCO, Calif., Sept. 23 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM) announced today that it has initiated a study, in collaboration with the Dana-Farber Cancer Institute (DFCI), to evaluate Monogram's HERmark(TM) Breast Cancer Assay in metastatic breast cancer.

In the study, Monogram's proprietary HERmark assay will be used to analyze approximately 600 tissue samples from patients with breast cancer, approximately half of whom were eligible for treatment with Herceptin(R) on the basis of prior HER2 IHC and/or FISH testing. HERmark measurements of HER2 total protein and HER2 homodimer levels will be compared with the results of IHC and/or FISH testing as well as response to treatment with Herceptin.

"Results from prior studies in metastatic breast cancer have suggested that HERmark can identify subsets of patients with different responses to Herceptin even though they had all been previously assessed as 'HER2-positive' by IHC and/or FISH, tested centrally," said Michael Bates, M.D., Monogram's Vice President of Clinical Research. "The aim of this study is to test the hypothesis that HERmark selects patients for Herceptin treatment in the metastatic setting better than other currently available assays, as well as to test cutoff values that have been previously defined for HERmark. In addition, we will also measure HER3 expression levels in these tumors and see if they correlate with clinical outcomes in this cohort. The study will also provide enough tissue to facilitate testing of assays that are in advanced development at Monogram, including assays for HER1 expression, p95 expression, as well as heterodimers of HER2, such as HER2:HER3 and HER1:HER2."

"The VeraTag technology represents a novel approach to the study of HER2- positive breast cancer by virtue of its ability to make accurate measurements of HER2 and its homodimer in actual breast tumors," said Ian Krop, M.D., Ph.D., Assistant Professor of Medicine, Division of Medical Oncology at the Dana Farber Cancer Institute and principal investigator of the study. "We look forward to working with Monogram on this study to try to develop a better understanding of the biology of HER2 positive breast cancer and the biomarkers that influence its clinical outcome."

About HERmark

HERmark is a proprietary diagnostic that accurately quantifies HER2 total protein levels and HER2 homodimerization in patients with breast cancer. HERmark is a CLIA-validated assay that is performed exclusively in Monogram's CAP-certified clinical reference laboratory in South San Francisco. Robust, accurate, sensitive and reproducible measurements of HER2 status are reported to physicians with a turnaround time of 7 days.

With the accurate measurements provided by HERmark, it is expected that as many as 15-20% of patients determined by conventional technologies to be HER2- negative would be reclassified by HERmark.

About Monogram

Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious 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. More information about the Company and its technology can be found on its web site at

About Dana-Farber Cancer Institute

Dana-Farber Cancer Institute is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana- Farber/Harvard Cancer Center (DF/HCC), a designated comprehensive cancer center by the National Cancer Institute.

Forward-Looking Statements

Certain statements in this press release are forward-looking. These forward-looking statements include references to the ability of the HERmark assay to predict response to Herceptin or to significantly improve the information available to physicians, results of studies intended to demonstrate clinical utility of HERmark, and potential commercialization of the HERmark assay or other VeraTag assays. These forward-looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: risks and uncertainties relating to the performance of our products, including HERmark; the risk that our VeraTag assays, including HERmark may not predict response to Herceptin or other therapeutic agents; the risk that we may not be able to obtain additional cohorts of patient samples for additional HERmark or VeraTag studies; our ability to successfully conduct clinical studies and the results obtained from those studies; whether larger confirmatory clinical studies will confirm the results of initial studies; our ability to establish reliable, high-volume operations at commercially reasonable costs; actual market acceptance of our products for patient use and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; whether payers will authorize reimbursement for our products and services and the amount of such reimbursement that may be allowed; whether the FDA or any other agency will decide to further regulate our products or services; whether the draft guidance on Multivariate Index Assays issued by FDA will be subsequently determined to apply to our current or planned products; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; restrictions on the conduct of our business imposed by the Pfizer, Merrill Lynch and other debt agreements; the impact of additional dilution if our convertible debt is converted to equity; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.

VeraTag and HERmark are trademarks of Monogram Biosciences, Inc. Herceptin is a registered trademark of Genentech, Inc.


Alfred G. Merriweather

Chief Financial Officer

Tel: 650 624 4576

Jeremiah Hall

Feinstein Kean Healthcare

Tel: 415 677-2700

SOURCE Monogram Biosciences, Inc.
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