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Focus Diagnostics, Inc. Signs Agreement With Stratagene To Develop Real-Time PCR In Vitro Diagnostic Products

12/5/2005 11:56:20 AM

HERNDON, Va., Dec. 5 /PRNewswire/ -- Today Focus Diagnostics announced that it has entered into a collaborative agreement with Stratagene Corporation whereby Focus will develop and commercialize infectious disease molecular products, supplied by Stratagene, for the clinical in vitro diagnostic (IVD) market worldwide. Under the terms of the agreement Stratagene has agreed to license its Full Velocity(TM) nucleic acid amplification technology and associated know-how to Focus for the development of molecular diagnostic products. Stratagene will manufacture and supply diagnostic products for Focus to commercialize worldwide and will also supply reagents for Focus to perform molecular diagnostic testing services in its reference laboratory.

Molecular testing has dramatically improved the process of detecting the presence of agents that cause both viral and non-viral infectious disease. Using nucleic acid-based diagnostics for the detection of DNA or RNA, clinical laboratories can deliver results within hours, allowing patients to receive appropriate treatment faster than with traditional testing methods. The greater sensitivity of amplified nucleic acid testing methods allow for the detection of microorganisms even when present in very low concentrations.

"Since the late 1980's Focus has served as a pioneer in the area of molecular testing for infectious diseases. Today we have one of the most comprehensive molecular test menus in the country. Expansion into molecular in vitro diagnostic product development is a natural extension of our molecular diagnostics expertise," notes Charles C. Harwood, Jr., CEO of Focus Diagnostics. "Our comprehensive evaluation of Stratagene's Full Velocity chemistry has convinced us of its exceptional performance characteristics in terms of speed, sensitivity and overall competitiveness. Our intention is to bring to market an innovative collection of FDA-cleared molecular products that will enable more laboratories to conduct testing that produces actionable results important to patient care."

"Stratagene is enthusiastic about the opportunities that will be created by our relationship with Focus," says Joseph A. Sorge, MD, President and CEO of Stratagene. "Both companies are innovators and we believe that the products resulting from this collaboration will allow an increasing number of laboratories to provide molecular testing services that will improve the speed and accuracy of diagnosing infectious diseases."

Even though the molecular diagnostics segment currently accounts for only 5% of the IVD market, it is expected to grow rapidly as a result of increasing investment by the IVD industry in this area. By 2010 revenues in the molecular diagnostics market are expected to reach $3.7 billion, representing an annual growth rate in excess of 20%. Infectious disease testing makes up the largest and fastest growing segment of the nucleic acid testing (NAT) market. Current tests are primarily for the detection of HIV, HBV, HCV and sexually transmitted diseases. Other segments of the molecular diagnostic market include oncology, cardiovascular, identity testing and prenatal screening.

About Focus Diagnostics, Inc.

Focus Diagnostics has served the healthcare community for nearly three decades as an innovative developer and provider of products and testing services for complex diagnostics, including infectious disease, autoimmune and newly introduced genetic testing. Focus Diagnostics' USFDA-registered and ISO 9001-certified diagnostics manufacturing facility and ISO 9001-certified reference laboratory are located in Cypress, California. Corporate headquarters are in Herndon, Virginia and Focus' Pharmaceutical Diagnostics Group, known as Focus Bio-Inova, is located in Herndon, Virginia and Plasir, France. For additional information about Focus Diagnostics, visit

Focus Diagnostics, Inc.

CONTACT: Mary Kay Mosch of Focus Diagnostics, Inc., +1-410-832-7575,

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