FDA Ponders KRAS: Next Step in Personalized Medicine Journey

Yesterday, Amgen (Nasdaq:AMGN) said that it is discussing the clinical utility of the KRAS gene as a predictive biomarker in patients who have a specific type of colorectal cancer with the FDA.  In one more sign that the era of blockbuster drugs is over, Amgen is actually putting forth the arguement that their drug should be used for only a subset of its initial target patient set – those who express the KRAS gene among other characteristics.

An interesting take by Luke Timmerman at Xconomy:  http://www.xconomy.com/seattle/2008/12/15/amgen-cancer-drug-getting-personal-which-may-be-a-good-thing-for-patients-and-sales/

This trend toward finding drugs that treat a particular patient’s disease rather than treating all patients with a disease is commonly referred to as personalized medicine, and it was predicted to take hold much more rapidly than it has.  What does it mean for investors? If the personalized medicine paradigm wins out, then the value chain in cancer medicine will shift towards disease characterization – or diagnostics.

Companies that can benefit from this trend include most reference laboratories but several smaller, more forward thinking firms are making great strides in bringing new biomarkers and novel tests to the market.  Those include Clarient, Inc (Nasdaq:CLRT) www.clarientinc.com, Esoterix www.esoterix.com, and Genoptix (Nasdaq:GXDX) www.genoptix.com.  Clarient CEO Ronnie Andrews is fond of saying that the days of fighting cancer by “burning down the haystack and hoping you get the needle” are ending, because we are developing the technology (like the KRAS marker) in many cases to identify the “needle” and treat it directly.

The diagnostics community will be watching this discussion carefully as an indicator that the tipping point for personalized medicine may be near (or not so near).


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