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Celera Presents Data Prescribing an Immunodiagnostic Assay to Detect Lung Cancer from Blood Serum

Panel of 6 protein biomarkers detected lung cancer with 94% sensitivity and 93% specificity

Additional data on pancreatic and colorectal cancer also to be presented

Alameda, CA - April 21, 2009

Celera Corporation (NASDAQ:CRA) today announced the presentation of data describing a novel mass spectrometry-based approach to identify and validate circulating protein biomarkers that detect non-small cell lung cancer (NSCLC). A key outcome of the study was the assembly of an immunoassay test for a panel of 6 biomarkers that detected lung cancer with 94% sensitivity and 93% specificity in a blinded analysis. In addition to detecting all stages of lung cancer studied and all major histological subtypes, the panel also accurately distinguished malignant cases from benign lung disease. The data will be presented from 8:00 a.m. to 12:00 p.m. MDT today as poster #3542 at the 100th Annual American Association for Cancer Research (AACR) Conference in Denver, CO.

“We believe these findings present an important development in our efforts to develop a robust method to detect lung cancer using a simple blood test,” said Steve Ruben, Ph.D., Vice President of Proteomics at Celera. “To this end, we have employed a novel mass spectrometry-based approach to finding biomarkers based on discovery from tumor tissues and tumor cell lines rather than from serum directly. This has allowed us to identify a collection of biomarkers which we have subsequently shown to be elevated in the blood of non-small cell lung cancer patients relative to appropriate controls.”

“We believe a test with this accuracy would have an opportunity to impact non-small cell lung cancer patient outcomes at many levels,” said Thomas White, Ph.D., Chief Scientific Officer at Celera. “For example, a test that precedes radiographic methods of detection, such as helical Computed Tomography, could reduce the number of patients requiring subsequent CT scans substantially, potentially reducing expensive workup and minimizing the morbidities associated with additional diagnostic procedures following a positive CT scan. We’re exploring the commercial opportunities for this program as we continue to validate these findings in a clinical setting.”

Study details
The study included 27 candidate biomarkers from approximately 500 proteins previously identified by mass spectrometry that were used to test serum specimens using ELISA (Enzyme Linked Immunosorbent Assay) methods in a pilot set of sera comprising 12 individuals with lung cancer and 12 healthy controls. Several of the selected markers have not previously been reported to show elevated expression in the blood of lung cancer patients. Markers that showed elevated disease expression in cancer patients were then validated in sera from 103 patients with NSCLC and 104 healthy controls who were matched for age, gender and smoking history. Cases comprised more prevalent histological types: adenocarcinoma (n=54), squamous cell (n=24) and large cell (n=11), and spanned all 4 stages of tumor progression. Additional control samples included 70 individuals with non-malignant lung disease, which included bronchitis, asthma, COPD, and benign pulmonary nodules.

The test panels that were configured detected lung cancer with higher sensitivity and specificity than previously reported. A blinded analysis was performed in which a logistic regression classifier was generated using a collection of serum samples (control, n=54; tumor, n=53). The performance of the classifier was then evaluated on a panel of blinded samples (control, n=50; tumor, n=50), and the 6-marker panel achieved 91% sensitivity at 91% specificity in correctly classifying cases and controls. This panel and others described in the study are expected to provide the flexibility to design tests with performance specifications suitable for a variety of diagnostic applications, such as screening individuals at risk for lung cancer and for monitoring of disease following diagnosis and treatment.

Biomarkers and Lung Cancer
Lung cancer is the leading cause of cancer mortality in the U.S. accounting for about 29% of all cancer deaths that occurred in 2008 (Cancer J Clin, 2008; 58:71-96). Currently, there are no guidelines for screening of individuals at risk for lung cancer, and current biomarkers are used only for monitoring of disease following diagnosis and treatment. Novel biomarker panels with improved performance, such as the one described in the current study, may have considerable value at various stages in the detection and diagnosis of lung cancer, which includes independent screening for high risk individuals, and/or for subsequent CT analysis used in combination with imaging technologies to improve resolution of malignant nodules. Such a panel could also be used to improve the monitoring of lung cancer progression by enhancing the management of pulmonary nodules that are identified through CT scanning.

Other data presented in pancreatic and colorectal cancer
Applying similar methodology to that described above for lung cancer, Celera has identified other multi-member biomarker panels capable of detecting pancreatic and colorectal cancer in serum samples, and is presenting results from these programs at the 100th Annual AACR conference today. These include:

  1. an oral presentation entitled, “Pancreatic cancer serum protein markers identified using mass-spectrometry based discovery platform” which describes a 7-member pancreatic cancer panel that is able to detect both early and late stage lesions with high performance; and,
  2. a poster presentation entitled, “Colon cancer serum protein markers identified using mass-spectrometry based discovery platform”, which describes markers in a 9-member colorectal panel that were shown to distinguish both proximal and distal lesions with 90% sensitivity and 93% specificity. These data demonstrate improved sensitivity over the Fecal Occult Blood Test, which the American Cancer Society recommends should be performed annually as part of a screening program for colorectal cancer in people over the age of 50 years.

About Celera
Celera is a healthcare business delivering personalized disease management through a combination of products and services incorporating proprietary discoveries. Berkeley HeartLab, a subsidiary of Celera, offers services to predict cardiovascular disease risk and improve patient management. Celera also commercializes a wide range of molecular diagnostic products through Abbott and has licensed other relevant diagnostic technologies developed to provide personalized disease management in cancer and liver diseases. Information about Celera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.celera.com.

Forward-Looking Statements
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,” “expect,” “will,” “should,” “anticipate,” “may,” “could,” and “intend,” among others. These forward-looking statements are based on Celera’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, Celera 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. The risks and uncertainties that may affect the operations, performance, development, and results of our business include, but are not limited to, the risks and uncertainties that: (1) Celera is using novel and unproven methods to discover markers for the development of new diagnostic products, which may not be successful; (2) the diagnostic industry is very competitive, and new diagnostic products may not be accepted and adopted by the market; (3) demand for diagnostic products may be adversely affected if users of these products cannot receive adequate reimbursement for these products from third party payors such as private insurance companies and government insurance plans; (4) potential product liability or other claims against Celera as a result of the testing or use of its products; and (5) uncertainty of the availability to Celera of intellectual property protection, limitations on its ability to protect trade secrets, the risk to it of infringement claims, and the possibility that it may need to license intellectual property from third parties to avoid or settle such claims The foregoing list sets forth some, but not all, of the factors that could affect Celera's ability to achieve results described in any forward-looking statements. For additional information about the risks and uncertainties that Celera faces and a discussion of its financial statements and footnotes, see documents filed by Celera with the SEC, including its transition report on Form 10-KT and all subsequent periodic reports. All information in this press release is as of the date of the release, and Celera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

Copyright© 2009. Celera Corporation. All Rights Reserved. Celera is a registered trademark of Celera Corporation or its subsidiaries in the U.S. and/or certain other countries.

Contact
David Speechly, Ph.D.
tel.: 510.749.1853
email: david.speechly@celera.com


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