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DxS Developing KRAS Companion Dx for Bristol-Myers Squibb/ImClone's Erbitux

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By Turna Ray

UK-based DxS has inked a deal with Bristol-Myers Squibb/ImClone Systems to develop a companion diagnostic test kit for the colorectal cancer drug Erbitux.

DxS already has a similar deal to develop a companion diagnostic for Amgen's colorectal cancer drug Vectibix.

Financial terms of DxS' agreement with BMS/ImClone were not disclosed.

Erbitux is developed by ImClone, a subsidiary of Eli Lilly. The drug, commonly known as cetuximab, is marketed in the US and Canada. Merck KGaA markets the drug outside these territories.

The KRAS diagnostic test kit to accompany Erbitux will be based on DxS' TheraScreen platform, which is currently undergoing pre-market approval at the US Food and Drug Administration [see PGx Reporter 03-04-2009].

"If approved by the FDA, the DxS TheraScreen: K-RAS Mutation Kit would become a companion diagnostic for use with Erbitux in metastatic colorectal cancer to determine which patients have wild-type KRAS status in the US," DxS said in a statement this week.

Until the company receives notice from the FDA about the regulatory status of its KRAS test, the assay is being sold as a laboratory-developed test through its partner Exiqon

The TheraScreen assay detects KRAS mutations in codons 12 and 13. The FDA recently update the labels of Erbitux and Vectibix to recommend that the monoclonal antibody EGFR inhibitors should not be administered to colorectal cancer patients with these mutations since the drugs will not benefit them [see PGx Reporter 07-22-2009].

Approximately 40 percent of metastatic colorectal cancer patients with mCRC have KRAS mutations, and 60 percent have the wild-type KRAS gene.

DxS' TheraScreen range of products is currently CE-marked in Europe. The company has developed two companion test kits under the TheraScreen brand, one that gauges KRAS mutations and another that detects EGFR mutations.

In addition to Amgen and BMS/ImClone, DxS has inked agreements to develop companion diagnostics for Boehringer Ingelheim and AstraZeneca.

DxS has a worldwide distribution deal with Roche Diagnostics for the KRAS test, as well as other products [see PGx Reporter 06-04-2008].

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