Abbott’s Vysis ALK FISH test approved as companion diagnostic

Abbott has been granted European regulatory approval for its Vysis ALK Break Apart FISH Probe Kit to be marketed as a companion diagnostic tool.

The product has been ratified for use in detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in advanced non-small cell lung cancer patients who may be eligible for treatment with Xalkori, a new drug from Pfizer.

It was the only diagnostic test used in multi-centre global clinical trials in conjunction with Xalkori and was shown to be able to help clinicians make important treatment decisions.

Previous trials have proven the performance of Vysis as a rapid, sensitive and specific test for detecting ALK gene rearrangements among lung cancer patients.

Kristina Rodnikova, head of Abbott's molecular diagnostics business in Europe, said: "Laboratories throughout Europe are familiar with and experienced in using the Vysis ALK FISH test so they will be able to start testing lung cancer patients immediately."

Earlier this month, the company published its financial results for the third quarter of 2012, during which it experienced a year-on-year sales increase of 4.1 percent on an operational basis.