Alliance to Develop In Vitro Diagnostics

A collaborative agreement between Focus Diagnostics (Herndon, VA, USA) and Stratagene Corp. (La Jolla, CA, USA) has been announced, whereby Focus will develop and commercialize infectious disease molecular products, supplied by Stratagene, for the worldwide clinical in vitro diagnostic (IVD) market.

Under the terms of the agreement, Stratagene will license its nucleic acid amplification technology, called Full Velocity, and associated know-how to Focus for the development of the molecular diagnostic products. In return, Stratagene will manufacture and supply diagnostic products for Focus to sell worldwide and will also supply reagents for Focus to use in performing molecular diagnostic testing services in its reference laboratory.

By using nucleic acid-based diagnostics for the detection of DNA or RNA, laboratories can now deliver results within hours, allowing patients to be treated sooner than before. Amplified nucleic acid testing is much more sensitive today and can detect microorganisms even in very low concentrations.

While the molecular diagnostics market segment now accounts for only 5% of the IVD market, it is expected to grow rapidly because of the increasing investment being made by the IVD industry in this area, according to Focus Diagnostics. By 2010, revenues in the molecular diagnostics market are forecast to reach U.S.$3.7 billion, which represents an annual growth rate of more than 20%. Infectious disease testing comprises the largest and fastest growing segment of the nucleic acid testing market.

"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,” said Charles C. Harwood, Jr., CEO of Focus Diagnostics. "Our intention is to bring to market an innovative collection of [U.S.]FDA (Food and Drug Administration)-cleared molecular products that will enable more laboratories to conduct testing that produces actionable results important to patient care.”





Related Links:
Focus Diagnostics
Stratagene