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Gen-Probe, Diagnocure Amend Prostate Cancer Test Deal

NEW YORK (GenomeWeb News) – Gen-Probe and DiagnoCure said this week that they have amended their 2003 license agreement regarding development and commercialization of a molecular diagnostic test for prostate cancer.

The amended deal establishes new Food and Drug Administration milestones and key distribution arrangements, the partners said in a joint statement.

San Diego-based Gen-Probe can fulfill the milestone for an FDA submission with its current end-point TMA assay or its investigational real-time TMA assay, they said. As part of the amendment, Gen-Probe will make annual payments of $500,000 to Diagnocure until specific milestones are met. Half of the amounts paid to DiagnoCure will be applied against future royalties payable to the Quebec-based firm.

As part of the deal, Gen-Probe will acquire 4.9 million shares of newly issued DiagnoCure convertible preferred stock for $5.0 million, representing a premium of 19.8 percent over the average market price of DiagnoCure's common shares during the 20 trading days from April 28. The convertible preferred shares are non-voting, and may be exchanged for common shares on a one-for-one basis, the firm's said.

Gen-Probe also said that it plans to initiate a pivotal clinical trial of the PCA3-based prostate cancer test during the third quarter of this year for potential regulatory clearance by FDA.

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