VLGC Virologic (MM)

ViroLogic's eTag System Demonstrates Potential Ability to Better Select Breast Cancer Patients for Therapy With Herceptin -Abstract #553- ORLANDO, Fla., May 17 /PRNewswire-FirstCall/ -- ViroLogic, Inc., (NASDAQ:VLGC) announced today the presentation of clinical data demonstrating the ability of the company's eTag(TM) assays to accurately predict treatment response for patients with breast cancer who receive Herceptin(R) (trastuzumab). The presentation took place at the 2005 American Society of Clinical Oncology (ASCO) Annual Meeting being held this week at the Orange County Convention Center in Orlando, FL. ViroLogic has developed a set of eTag assays that enables broader analysis of the human epidermal growth factor receptor (HER) family than just HER2/neu, the target for the antibody drug Herceptin, and uniquely permits measurement of "activated" HER receptors in fixed patient tumor samples. Breast cancer patients who over-express the HER2/neu protein, or who have excess copies of the HER2/neu gene, are typically treated with Herceptin. However, approximately 60% of patients that test positive for HER2/neu by these methods and are treated with Herceptin do not respond to therapy, suggesting that other mechanisms are likely driving tumor cell growth and contributing to disease progression in these patients. "Our data indicate that the eTag assays, which are directed to activated HER receptor family targets, may more accurately predict response in patients with breast cancer than current methods that look at gene amplification and protein levels of just HER2," said Sharat Singh, Ph.D., ViroLogic's Chief Technical Officer, Oncology, and co-author of the study. "A larger study of Herceptin-treated patients is being undertaken to further assess the clinical utility of eTag assays in the selection of breast cancer patients for receptor-targeted therapies." Researchers at ViroLogic used eTag assays to analyze breast tissue biopsies from 30 patients treated with Herceptin, including 13 samples from an earlier study with the Tokyo Metropolitan Institute of Medical Science (Rinshoken), to determine total HER receptor family expression, HER homo- and heterodimer levels (indicative of activated receptor) and the phosphorylation states of the HER receptors on formalin-fixed, paraffin-embedded tissue sections. The data from these studies were then used to correlate with patient response to Herceptin. Patient samples were analyzed blinded, and the patients were divided into two groups based on their HER receptor activation level. In the first group were patients who exhibited high levels of HER3-containing dimers, and who were predicted to have progressive disease because Herceptin does not affect these molecules. In the second group were patients who showed high levels of HER2/neu homodimers only, or high levels of HER2/neu homodimers and low to moderate levels of Her3-containing heterodimers, who were predicted to respond (complete response/partial response/stable disease) to Herceptin treatment. The difference between these two groups based on the eTag assay-predicted clinical response to Herceptin treatment was highly statistically significant, reaching a p-value of 0.0017. Sensitivity was 90% and specificity was 70%. "These expanded study results are consistent with our early findings from the Rinshoken study, where medium-to-high levels of Her2 homodimers when coupled with high levels of Her3 heterodimers, as measured by eTag assays, had a negative correlation with response," continued Dr. Singh. About the eTag System ViroLogic's eTag assays enable detailed analysis of protein drug targets and signaling pathways in cancer cells, including samples that are formalin-fixed, paraffin-embedded, which is the standard format in most pathology labs. The assays can provide information on a drug's mechanism of action, selectivity and potency in a biological setting in pre-clinical research, and enable enrichment or selection of clinical trial populations later in a drug's development. In addition, ViroLogic believes these assays may ultimately be used to help physicians better determine whether certain therapies are more appropriate for individual cancer patients, and whether to combine therapies with different mechanisms or properties. The first commercially available activated receptor test panel based on eTag technology, focused on the EGFR/HER receptor family, is planned to be introduced in 2006. About ViroLogic ViroLogic is a biotechnology company 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 antiviral 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.virologic.com/. FORWARD LOOKING STATEMENTS Certain statements in this press release are forward-looking, including statements regarding the trend toward individualized medicine and the results of yet-to-be completed clinical studies related to the effectiveness of our eTag assays as predictive tools for targeted cancer therapies. 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 development of future products; the performance of our products; 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; whether larger studies involving tumor samples will yield favorable results regarding the predictive capability of eTag assays for responsiveness to Herceptin; our ability to establish reliable, high-volume operations at commercially reasonable costs; our ability to introduce a product commercially in 2006; our ability to successfully integrate the operations of ACLARA into our operations; competition from larger more established diagnostic providers; 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 level of demand for our products; the timing and ultimate size of pharmaceutical company clinical trials; whether payors will authorize reimbursement for our products; whether the FDA or any other agency will seek to regulate ViroLogic's in house clinical laboratory testing; our ability to comply with FDA regulations in order to establish and maintain diagnostic kit manufacturing operations; whether we will encounter problems or delays in establishing and validating eTag assays within our clinical laboratory; whether we will encounter problems or delays in automating our processes or expanding our capacity; whether the intellectual property underlying the Company's technology is adequate; whether we may be deemed to infringe on the intellectual property of others and whether licenses to third party technology will be available; whether ViroLogic is able to build brand loyalty and expand revenues; the potential impact of any payments under the CVRs on our common stock and capital resources; and whether ViroLogic will be able to raise sufficient capital when required. For a discussion of other factors that may cause ViroLogic's actual events to differ from those projected, please refer to the Company's 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. NOTE: eTag is a trademark of ViroLogic, Inc. Herceptin(R) is a registered trademark of Genentech. DATASOURCE: ViroLogic, Inc. CONTACT: Alfred Merriweather, Vice President and CFO of ViroLogic, +1-650-635-1100, or Carolyn Bumgardner Wang of WeissComm Partners, +1-415-225-5050, or , for ViroLogic Web site: http://www.virologic.com/

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