ROCKVILLE, Md.--(BUSINESS WIRE)--Aug. 21, 2006--Celera Genomics (NYSE:CRA - News), an Applera Corporation business, today announced that the National Institutes of Health (NIH) has awarded Celera approximately $900,000 to develop and commercialize an in vitro diagnostic (IVD) test for the highly pathogenic influenza A/H5 virus (Asian lineage, H5N1). The test Celera plans to develop will be based on the Primer and Probe Set and protocols used in the test from the U.S. Health and Human Services’ Centers for Disease Control and Prevention (CDC) recently cleared by the U.S. Food and Drug Administration (FDA). The CDC assay is the only FDA-cleared assay for detection of the H5N1 virus, and its use is limited to the laboratories designated by the Laboratory Response Network. Celera’s access to the H5N1 assay information will be through a license to be obtained by Celera from the CDC. The test is expected to be sold through Celera’s alliance with Abbott.
“Early detection of avian influenza H5N1 in humans could allow for intervention with antiviral therapeutic drugs and institution of vaccination or quarantine strategies to prevent or delay spread of the infection,” said Tom White, Ph.D., Chief Scientific Officer at Celera. “An accurate, standardized, and robust test would enable testing in more locations, and most importantly, enable investigators to make meaningful comparisons between laboratories quickly and reliably across the globe. The assay format that we’re developing is expected to be suitable for widespread testing should a pandemic occur.”
The grant will partially support a multi-phased, three year project. Performance testing and validation will be done in collaboration with the CDC, which has accumulated a large collection of influenza strains and clinical respiratory specimens as a World Health Organization (WHO) Collaborating Center for Surveillance, Epidemiology and Control of Influenza, as well as with other interested laboratories.
“We have a track record of developing and commercializing molecular diagnostic tests for human viral pathogens based on real-time PCR technology, which specifically and rapidly detects and quantifies low levels of pathogens,” said Michael Zoccoli, Ph.D., Vice President of Development at Celera. “The information from the CDC’s FDA-cleared test and their vast influenza strain and specimen collection, combined with Celera’s diagnostic product development and manufacturing expertise, should drive rapid progress on a test that could be broadly used in the event of a pandemic.”
The avian influenza test to be developed by Celera is expected to run on Abbott’s new m2000(TM) instrument system for detecting and monitoring infectious diseases, using automated real-time PCR technology from Applied Biosystems. The m2000 is currently available in Europe with CE Mark certification and is pending 510(k) clearance with the FDA in the United States.
About Applera Corporation and Celera Genomics
Applera Corporation consists of two operating groups. Celera Genomics 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 Genomics 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 Genomics 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 http://www.applera.com, or by telephoning 800.762.6923. Information about Celera Genomics is available at 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,” “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 Genomics’ unproven ability to discover, develop, or commercialize proprietary diagnostic products; (2) uncertainty that the Avian Flu assay will be accepted by the market, including the risk that this product will not be competitive with products offered by other companies; (3) reliance on existing and future collaborations with other companies, including, in the case of Celera Genomics, its strategic alliance with Abbott Laboratories, which may not be successful; (4) intense competition in the industries in which Celera Genomics operate; (5) potential product liability or other claims against Celera Genomics as a result of the testing or use of their products; (6) uncertainty of the availability to Celera Genomics of intellectual property protection, limitations on their ability to protect trade secrets, the risk to them of infringement claims, and the possibility that they may need to license intellectual property from third parties to avoid or settle such claims; (7) legal, ethical, and social issues which could affect demand for Celera Genomics’ products; and (8) 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.
Copyright© 2006. Applera Corporation. All rights reserved. Celera is a registered trademark and Applera, Applied Biosystems and Celera Genomics are trademarks of Applera Corporation or its subsidiaries in the U.S. and/or certain other countries. m2000 is a trademark of Abbott or its subsidiaries in the U.S. and/or certain other countries.
Contact: Celera Genomics David Speechly, Ph.D., 510-749-1853 david.speechly@celera.com
Source: Celera Genomics
