Celera Presents Data Validating Its Metastasis Score as a Molecular Prognostic Tool in Breast Cancer
Metastasis Score developed in untreated patients predicts risk of metastasis in Tamoxifen®-treated breast cancer patients
ROCKVILLE, MD - February 22, 2007
Celera (NYSE:CRA), an Applera Corporation business, today announced the presentation of data supporting its multi-gene expression prognostic constellation as a predictor of distant metastasis in Tamoxifen®-treated breast cancer patients. The prognostic constellation provided information that is distinct to that predicted by routine clinical assessment tools, such as tumor grade, and can quantify risk for metastasis for variable time periods rather than only categorically for 5 or 10 years. A key finding was the calculation of a Metastasis Score (MS) for breast cancer that predicts a 3.5-fold difference in risk between the 20 percent of women at highest risk and the 20 percent of women at lowest risk. The data is being presented as a poster at the 24th annual Miami Breast Cancer Conference in Miami Beach, FL.
The current study was based on Tamoxifen-treated research subjects from Guy’s and St. Thomas Hospitals in London, United Kingdom. It is the second study to evaluate a 14-gene signature discovered by Celera scientists and academic collaborators at the University of California at San Francisco, CA, for predicting distant metastatic risk in node-negative (N-), early stage, estrogen receptor positive (ER+) breast cancer. The current findings further validate a previously reported research study with the University of Muenster in Germany, in which untreated and Tamoxifen-treated research subjects were studied using formalin-fixed paraffin embedded (FFPE) tissue sections. The use of FFPE sections permits the same procedure to be used for both archival specimens and routinely prepared sections. The initial validation of the gene expression constellation research data was presented by Celera at the Association for the Advancement of Cancer Research’s Oncogenomics 2007 conference in Phoenix, AZ, in February 2007.
“These research studies are providing additional insights into important pathways involved in breast cancer metastasis,” said Andrew Tutt, M.D., Ph.D., Consultant Oncologist at Guy’s and St. Thomas’ Hospitals, and co-author on the current study. “Large scale studies with well-characterized samples linked to long term patient outcome data, such as these, hold significant promise to enable the development of new diagnostics and targeted therapeutics.”
“It’s important to highlight that this metastasis score for breast cancer was developed and validated on untreated research subjects, and as such, meets the criteria for prognostic use independent of specific treatment regimens,” said John J. Sninsky, Ph.D., Vice President Discovery Research at Celera, and lead author on the current study. “This metastasis score has now been demonstrated to be prognostic in two independent sample sets.”
Laboratory Corporation of America® Holdings (LabCorp) (NYSE:LH), one of the largest independent clinical laboratories in the United States, also collaborated with Celera on the current study. Celera and LabCorp have been seeking to establish the clinical utility of laboratory developed tests based on novel diagnostic markers for breast cancer since 2002.
The current research study aimed to determine the performance in Tamoxifen-treated research subjects of a previously developed 14-gene metastasis score that predicted distant metastasis in breast cancer research subjects without systemic treatment. Many of the genes in this constellation are involved in the p53 and TNF signaling pathways and are implicated in cancer proliferation. The absence of the estrogen receptor gene in the constellation increases the confidence that this information complements routinely assayed estrogen receptor levels determined by immunohistochemistry.
The study involved a cohort of 213 node negative, estrogen receptor positive Tamoxifen-treated breast cancer research subjects from Guy’s Hospital, London, UK. The cohort included 63 percent of research subjects > 55 yrs with tumor size smaller than or equal to 3 cm, and a median follow up of 9.3 yrs. The primary endpoint was distant metastasis-free survival. RT-PCR was carried out on RNA extracted from FFPE sections. Continuous metastasis scores and differential risk per unit increase in metastasis scores were calculated. MS can be used to classify research subjects into high and low-risk groups as well.
The current research study was carried out because the previously derived metastasis risk score for untreated patients was expected to provide a baseline risk assessment for any treatment regimen.
About Breast Cancer
Breast cancer is the most common cancer among women, other than skin cancer. It is the second leading cause of cancer death in women, after lung cancer. According to the World Health Organization, more than 1.2 million people will be diagnosed with breast cancer this year worldwide. It is estimated that more than 40,000 deaths will occur from breast cancer each year in the United States. The death rates from breast cancer declined significantly between 1992 and 1996, with the largest decreases among younger women. Medical experts attribute the decline in breast cancer deaths to earlier detection and more effective treatments.
About Applera Corporation and Celera
Applera Corporation consists of two operating groups. Celera is primarily a molecular diagnostics business that is using proprietary genomics and proteomics discovery platforms to identify and validate novel diagnostic markers, and is developing diagnostic products based on these markers as well as other known markers. Celera maintains a strategic alliance with Abbott for the development and commercialization of molecular, or nucleic acid-based, diagnostic products, and it is also developing new diagnostic products outside of this alliance. Through its genomics and proteomics research efforts, Celera is also discovering and validating therapeutic targets, and it is seeking strategic partnerships to develop therapeutic products based on these discovered targets. The Applied Biosystems Group serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services. Customers use these tools to analyze nucleic acids (DNA and RNA), small molecules, and proteins to make scientific discoveries and develop new pharmaceuticals. Applied Biosystems’ products also serve the needs of some markets outside of life science research, which we refer to as “applied markets,” such as the fields of: human identity testing (forensic and paternity testing); biosecurity, which refers to products needed in response to the threat of biological terrorism and other malicious, accidental, and natural biological dangers; and quality and safety testing, for example in food and the environment. Applied Biosystems is headquartered in Foster City, CA, and reported sales of over $1.9 billion during fiscal 2006. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at www.applera.com, or by telephoning 800.762.6923. Information about Celera is available at www.celera.com.
Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "plan," and "should," among others. These forward-looking statements are based on Applera Corporation’s current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Applera notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to: (1) Celera’s unproven ability to discover, develop, or commercialize proprietary diagnostic products; (2) the risk that studies or trials of products that Celera does discover and develop will not proceed as anticipated or may not be successful, or that such products will not receive required regulatory clearances or approvals; (3) the uncertainty that Celera’s products will be accepted and adopted by the market, including the risk that these products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for these products from third party payors such as private insurance companies and government insurance plans; (4) legal, ethical, and social issues which could affect demand for Celera’s products; and (5) other factors that might be described from time to time in Applera’s filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Applera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
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