With hundreds of new drugs in development, cancer is a top priority for drugmakers including Pfizer, AstraZeneca, Roche, Novartis, GlaxoSmithKline and Sanofi-Aventis, all of whom are busy incorporating diagnostic biomarkers into their drug trials.
Translating the complex messages from genetic assays into clinical practice is not always easy.
Research published this week found up to two-thirds of patients with aggressive breast cancer were not tested for the HER2 gene to see if they should get Herceptin, while one in five of those who were may have had incorrect results.
Roche’s Herceptin, which has annual sales of nearly US$5 billion, was the first of the new generation of targeted cancer drugs linked to a biomarker test, or “companion diagnostic.”
“There are huge issues around quality control of the companion diagnostics,” Verrill said. “It’s not like testing if the lights are on or off. It’s generally a question of a threshold having to be reached and there is a spectrum of positivity for any of these tests.”
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