Applied Biosystems Receives FDA 510(k) Clearance For Real-Time PCR Instrument For Use With New Flu Test From U.S. Centers For Disease Control And Prevention

FOSTER CITY, Calif.--(BUSINESS WIRE)--Applied Biosystems Inc. (NYSE:ABI) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its new 7500 Fast Dx Real-Time PCR Instrument for use with the new CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel) from the U.S. Centers for Disease Control and Prevention. While both products received independent FDA 510(k) clearances, they are required to be used together as a system for the detection of influenza.

Together with the 7500 Fast Dx Real-Time PCR Instrument, the new CDC diagnostic assay is designed to help standardize influenza virus testing and sub-typing and provide accuracy, specificity and dependability of influenza test results among qualified laboratories that conduct influenza subtype testing in the United States. Developed through a coordinated effort between the CDC and Applied Biosystems, the new test can accurately detect and identify commonly circulating human influenza viruses as well as avian influenza A (H5N1, Asian lineage) viruses within four hours and in multiple samples at one time. The test enables clinical researchers to discriminate between both the common seasonal subtypes of flu as well as the avian influenza A subtype, in order to aid public health officials in making a rapid and accurate diagnosis.

"The FDA's decision to clear our real-time PCR instrumentation is an important milestone for Applied Biosystems as it presents us with an exciting opportunity to apply our technology to the rapidly growing clinical diagnostics market," said Mark Stevenson, president and chief operating officer for Applied Biosystems. "In this instance, we've been able to apply our real-time PCR technology to support laboratories on the front line of influenza testing in the United States. This is an important diagnostic tool that will enhance monitoring of influenza infections each year and improve early detection of influenza viruses with pandemic potential in the United States and abroad."

Applied Biosystems is a worldwide leader in real-time PCR instruments. The 510(k) clearance for the 7500 Fast Dx Instrument is the company's first clearance for a real-time PCR instrument for the clinical diagnostics market. Real-time PCR (polymerase chain reaction) is a common laboratory method which measures PCR amplification as it occurs, cycle-by-cycle, allowing quantitative measurements to be made in the highly reproducible exponential phase of PCR. This enables extremely accurate and precise quantitation over a large dynamic range compared to traditional techniques.

The 510(k) clearance for the 7500 Fast Dx Real-Time PCR Instrument follows the recent ISO 13485:2003 Quality System certification for the Applied Biosystems Singapore facility awarded by The British Standards Institution Americas, Inc., which enables CE Marking to the In-Vitro Diagnostics Directive 98/79/EC of products for sale within the European Community.

The Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument employs 96-well format reaction plates and enables scientists to complete real-time PCR amplification in less than 40 minutes. CDC-qualified laboratories that previously purchased the 7500 Fast Real-Time PCR System should contact their Applied Biosystems representative for information on how to purchase a ‘Dx' upgrade to the 7500 Fast Dx Real-Time PCR Instrument for use with the new CDC flu assay. For more information please visit http://www.appliedbiosystems.com.

About Applied Biosystems Inc.

Applied Biosystems Inc. (formerly known as Applera Corporation) is a global leader in the development and marketing of instrument-based systems, consumables, software, and services for academic research, the life science industry and commercial markets. Driven by its employees' belief in the power of science to improve the human condition, the company commercializes innovative technology solutions for DNA, RNA, protein and small molecule analysis. Customers across the disciplines of academic and clinical research, pharmaceutical research and manufacturing, forensic DNA analysis, and agricultural biotechnology use the company's tools and services to accelerate scientific discovery, improve processes related to drug discovery and development, detect potentially pathogenic microorganisms, and identify individuals based on DNA sources. Applied Biosystems has a comprehensive service and field applications support team for a global installed base of high-performance genetic and protein analysis solutions. Applied Biosystems Inc. is headquartered in Norwalk, CT. On June 12, 2008, Applera Corporation and Invitrogen Corporation (NASDAQ:IVGN) announced that their Boards of Directors had approved a definitive merger agreement under which Invitrogen will acquire all of the outstanding shares of Applied Biosystems stock. The merger is subject to customary closing conditions and is targeted to close in the fall of 2008. Further information regarding the merger is contained in a joint proxy statement/prospectus that has been mailed to stockholders of the company and Invitrogen. Investors and security holders are urged to read this document because it contains important information. Information about Applied Biosystems, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.appliedbiosystems.com. All information in this news release is as of the date of the release, and Applied Biosystems does not undertake any duty to update this information unless required by law.

Applied Biosystems 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 "should," "expect," and "planned," among others. These forward-looking statements are based on Applied Biosystems' 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, Applied Biosystems 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) rapidly changing technology and dependence on the development and customer acceptance of new products; (2) sales dependent on customers' spending policies; (3) diagnostic products may not receive required regulatory clearances or approvals; (4) the markets for clinical laboratory testing services and diagnostic products are very competitive, healthcare providers may prefer to use better-known laboratories for clinical testing, and healthcare providers may not accept new diagnostic products developed by the company, and (5) other factors that might be described from time to time in Applied Biosystems' filings with the Securities and Exchange Commission.

©Copyright 2008. Applied Biosystems Inc. All rights reserved. Applied Biosystems and AB (Design) are registered trademarks of Applied Biosystems or its subsidiaries in the U.S. and/or certain other countries.

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