U.K. firm DxS hopes a collaboration with AstraZeneca announced July 31 will be a small first step toward gaining a foothold in the yet-unformed European companion diagnostics market.

Under the agreement, DxS is "working closely" with the drug firm to make its CE marked TheraScreeen EGFR29 gene assay available to inform use of the drug firm's recently approved Iressa lung cancer therapy.

European authorities granted market clearance to Iressain early July. It was approved only for patients with certain activating mutations of the gene that expresses the protein targeted by the drug, epidermal growth factor receptor (EGFR).

A trial supporting the European approval found that not only did patients with the targeted mutation do better than with standard chemotherapy, but patients without the mutations "actually did worse," according to Peter Collins, VP-business development for DxS.

AstraZeneca assessed different technologies for identifying the needed genetic markers during the clinical trial phase and "was very happy with the performance of our test," Collins claimed. This sparked the sort of gentlemen's agreement that was announced last week: "Wherever DxS and the local AstraZeneca affiliate can work together to ensure there is access to our technology and our testing, we will work together to do so," as Collins describes it.

It is a far cry from a full-fledged commercial co-marketing agreement, he acknowledges. That is in recognition of a practical reality: that the test will not be reimbursed in most of Europe for some time.

In most cases, EGFR testing will be carried out on assays designed in-house by labs; the AstraZeneca sales force, however well-funded, is not going to be able to change that, Collins acknowledges. He hopes that the small number of assays the firm is able to place with the help of AstraZeneca will over time help make the case to government payers that its assay, which will be available on a Roche Diagnostics platform later this year, will provide more consistent results than lab-developed tests, and thus is worth supporting.

"This represents an early opportunity for our test to be used for clinical purposes," he said.

[Editor's note: This story appears courtesy of the editorial staff of 'The Gray Sheet,' your source for coverage of devices and diagnostics. For a sample copy, call customer service at 800-332-2181.]

-David Filmore (d.filmore@elsevier.com)

DxS Hopes AstraZeneca's Iressa EU Launch Will Help Build Companion Test Business

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