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Roche, Qiagen Make Up Over Distributing DxS' TheraScreen Tests


This article was posted May 27.

Roche Molecular Systems and Qiagen have reconciled their tiff over distribution rights for the Therascreen suite of genetic tests from Qiagen subsidiary DxS.

According to Qiagen, the two firms signed an out-of-court agreement this week in which Roche retained rights to distribute Therascreen-branded test kits that detect EGFR and KRAS mutations in cancer patients. The agreement includes conditions under which Roche can retain distribution rights for future versions of these tests. Additionally, Roche has the option to extend the term of its distribution rights for the EGFR assay beyond 2011, when the agreement is slated to expire.

Simultaneously, Qiagen also retained rights to distribute these tests under its own label, and obtained exclusive distribution rights for all other tests, including future versions of the assays developed by DxS.

After these agreements were reached, both Qiagen and Roche withdrew their claims filed against one another in lawsuit filed in the US Southern District Court of New York.

In June 2008, Roche and DxS signed a distribution agreement granting Roche exclusive global distribution rights for DxS' TheraScreen KRAS Mutation Test and the TheraScreen EGFR 29 Mutation Test in all markets except the US, Canada, Mexico, and Hong Kong (PGx Reporter 06/04/08).

Then after Qiagen acquired DxS last fall, the distributions rights over these tests began to get murky.

In a complaint filed with the New York federal district court, Roche accused DxS of trying to get out of its distribution deal by asserting "unfounded allegations" that Roche did not fulfill its obligation to develop software that would allow DxS' products to run on Roche's Cobas 4800 system. Roche maintains that the contract in question is a distribution agreement and not a manufacturing deal. As such, Roche maintained it was not in breach of its distribution agreement with DxS.

Roche also charged DxS of failing to hold up its end of the distributor agreement by falling behind on delivering TheraScreen KRAS tests and by not updating its EGFR test.

According to Roche, DxS was planning to terminate the distribution agreement by Feb. 15 if an agreement between the two parties had not been reached. At the time, DxS denied Roche's allegations.

Since the companies settled the dispute out of court, the terms of the agreement have not been disclosed.