Gen-Probe Acquires Rights from Qualigen

Gen-Probe has acquired from Qualigen an exclusive option to develop a point-of-use nucleic acid testing (NAT) instrument based on Qualigen's FDA-approved FastPack(R) immunoassay system.

If development is successful, the portable instrument would use Gen-Probe's NAT technologies to rapidly detect, at the point of sample collection, the presence of harmful microorganisms and genetic mutations. The platform could be used in physicians' offices, outpatient clinics, blood screening centers and various industrial settings.

Under the terms of the agreement, Gen-Probe will pay Qualigen $1 million for an 18-month option to license, on an exclusive basis, Qualigen's technology to develop NAT assays for the clinical diagnostics, blood screening and industrial fields. During this period, Gen-Probe intends to evaluate the feasibility of adapting Qualigen's immunoassay platform to perform NAT using Gen-Probe's proprietary technologies.

If Gen-Probe exercises its option, it will purchase shares of Qualigen preferred stock convertible into approximately 19% of Qualigen's fully diluted common shares outstanding. The cost of acquiring this equity interest may vary between $5.9 and $7.0 million, depending on the timing of the option exercise. In addition, Gen-Probe may pay Qualigen up to $3 million in license fees based on development milestones, as well as royalties on any eventual product sales.

Qualigen's FastPack(R) system is an automated blood testing system that provides rapid, fully quantitative immunoassay test results in physician offices and other point-of-care locations. The system's current test menu includes total PSA, free PSA (internationally), and testosterone. Qualigen has placed more than 400 FastPack(R) systems to date. Approximately 70% have been sold in the United States, and the balance in Europe.