West Coast Editor

Gen-Probe Inc. is checking out the feasibility of making a point-of-use nucleic acid-testing instrument based on Qualigen Inc.'s FDA-approved FastPack immunoassays, and is paying the latter $1 million for an 18-month license option.

Gen-Probe's stock (NASDAQ:GPRO) closed Thursday at $38.59, up 1 cent. Neither company could be immediately reached for comment.

If Gen-Probe goes ahead with the option, the firm would buy shares of Qualigen preferred stock convertible into about 19 percent of Qualigen's fully diluted common shares outstanding, for a cost of between $5.9 million and $7 million, with the precise amount depending on timing. Gen-Probe also could pay Qualigen up to $3 million in license fees based on development milestones, as well as royalties.

Qualigen's FastPack is an automated blood-testing system that provides quick, quantitative immunoassay results in physicians' offices and other points of care. The system's current test menu includes total prostate-specific antigen, free PSA (internationally) and testosterone. Qualigen has sold more than 400 of the systems, 70 percent of them in the U.S.

Gen-Probe, which offers a portfolio of bug-detecting tests that are used worldwide, hopes to come up with a portable instrument that deploys its own nucleic acid-testing technology for use at the point of sample collection.

The firm also is known for having developed and made the only FDA-approved blood-screening assay for simultaneous detection of HIV-1 and hepatitis C virus, the Procleix System, which is marketed by Chiron Corp., of Emeryville, Calif.

In October, Gen-Probe and Chiron said a design dossier amendment for use of the Procleix Ultrio Assay on the Procleix Tigris System had been submitted to Gen-Probe's European-notified body. The change would allow the already CE-Marked assay to be run on the Tigris high-throughput instrument platform, as well as on the Procleix System, which is a semi-automated instrument platform. Procleix Ultrio was developed to simultaneously detect HIV-1, HCV and hepatitis B in donated blood, plasma, organs and tissue. In the U.S., a biologics license application had been submitted several weeks earlier.

Also last month, Gen-Probe signed licensing agreements with Paris-based bioMerieux and its affiliates granting access to ribosomal RNA technologies and, in return, providing Gen-Probe admittance to bioMerieux's intellectual property related to genetic mutation detection, specifically in blood-clotting disorders. Terms include a payment to Gen-Probe of up to $250,000 for a limited nonexclusive research license and options to develop diagnostic products for certain targets using its technology. Options in that deal, if exercised, could be worth $4.5 million.