HER1 and HER3 VeraTag(TM) Assays are Now Available for Use in Development and Clinical Evaluation of Cancer Therapeutics

SOUTH SAN FRANCISCO, May 1 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM) today announced that the company's HER1 and HER3 Quantitative Protein Assays are now available for clinical development use. Built on Monogram's VeraTag(TM) platform, the HER1 and HER3 assays provide unique, quantitative measurements of protein expression and activity in formalin fixed paraffin embedded (FFPE) tumor samples. These assays supplement HERmark(TM), 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."

"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. In addition to the HER1 and HER3 assays that are now available for clinical development use, Monogram has assays in advanced development for the measurement of heterodimers of HER1 and HER2 (HER1:HER2), for the measurement of heterodimers of HER2 and HER3 (HER2:HER3), and for the measurement of a truncated form of HER2, known as p95. These activated proteins are believed to mediate resistance to Herceptin(R) in patients with breast cancer and are targets of other cancer drugs in development. This extended range of assays will expand the clinical reach of Monogram's assays to lung, colorectal and other cancers. Understanding these protein markers is expected to inform the rational design of combination therapies, such as those for patients with resistance to Herceptin.

About HERmark

HERmark is a proprietary diagnostic that accurately quantifies HER2 expression and HER2:HER2 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 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.

About VeraTag

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 (FFPE) patient samples.

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 http://www.monogrambio.com.

Forward Looking Statements

Certain statements in this press release are forward-looking. These forward-looking statements include references to, the ability of VeraTag technology to significantly improve the information available to physicians, results of studies intended to demonstrate clinical utility of our VeraTag technology and products and anticipated clinical and laboratory validation of VeraTag in a CLIA setting, future commercialization of the HERmark assay based on the VeraTag technology, expected protection provided by patents, and possible regulation of our products by the FDA. 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; the growth in revenues; the risk that our VeraTag assays may not predict response to particular therapeutic agents; the risk that we may not be able to obtain additional cohorts of patient samples for additional 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 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; the timing and ultimate size of pharmaceutical company clinical trials; 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.

SOURCE Monogram Biosciences, Inc.