Canadian regulatory authorities approved DxS’ TheraScreen K-RAS Mutation Kit for use as a diagnostic for anti-EGFR therapies and as a companion diagnostic for Amgen’s colorectal cancer therapy, Vectibix. Colorectal cancer patients may now be screened to assess their suitability for treatment with Vectibix, which is aimed at the 60% or so of patients with the wild-type K-RAS gene, DxS suggests.
The kit will be distributed in Canada by Roche Diagnostics as part of its exclusive distribution agreement for the TheraScreen K-RAS Mutation Test and TheraScreen EGFR 29 Mutation Test, signed in 2008.
The TheraScreen K-RAS Mutation Kit is designed to detect 7 K-RAS mutations in codons 12 and 13. The kit is CE-marked for commercial use in Europe and is also available in some countries that recognize the CE mark, including Australia, Saudi Arabia, and South Africa, comments Jen Lewis, marketing coordinator at DxS.
In countries where the test has been approved it may also be used as a companion diagnostic to Vectibix and also to the EGRF inhibitor Erbitux, although no formal agreements have been signed, Lewis added. The K-RAS Mutation Kit has yet to be approved in the U.S., although DxS’ K-RAS Mutation Test Kit is available in the U.S. for research use. In December 2008 DxS signed an agreement with Amgen to provide a K-RAS companion diagnostic for Vectibix® in the U.S.