Which Drug Works for You?

We’re all unique and often so are features of the diseases we may develop. For example, “cancer” is a term as diverse as “infection”. This means one drug will rarely work for every one of us. Similar to how we often identify pathogens during infection to target them effectively, validated genetic biomarkers identify whether we're likely to respond well to a particular drug. The diagnostic used to test drug-suitability is called a companion diagnostic (companion to the drug).

A significant milestone for QIAGEN and personalized healthcare in general was the 2012 approval by the US Food and Drug Administration (FDA) and subsequent launch of the companion diagnostic for the drug Erbitux. Prior to this, an approved standardized, highly reliable KRAS test paired with an important drug for metastatic colorectal cancer had not been achieved. In this success, our collaborative drug-industry partners were Bristol-Myers Squibb, Eli Lilly, and ImClone. Collectively, we pioneered the path to giving healthcare professionals the stringent, fully validated product they required. Within a few months, nearly half the corresponding tests in the US alone used our kit, demonstrating the acceptance of our setup for real-world practice.

Patients benefit from companion diagnostics by receiving a drug more suitable for them. But gains are also achieved in health economics from targeted delivery of a more effective treatment, rather than the traditional sequential trial approach.

Continuous team communication is critical to progress in personalized healthcare. Both drug and companion diagnostic are regulated. The drug needs to trial in patients identified with its companion diagnostic to gain regulatory approval. Hence, early collaboration with a drug company is a must to develop the market-ready version of our test before the final — and most expensive — drug trial before regulatory submission.

The technological hurdle in creating a drug’s companion diagnostic is finding a system to reliably amplify and detect infrequent mutations against a background of “normal” DNA, and yet remain practical and easily interpretable for labs and physicians. The “Scorpions” technology used in QIAGEN companion diagnostics is our proven solution, allowing detection of mutations by a simple fluorescence signal from the real-time PCR cycler.

QIAGEN continues to work tirelessly in partnership with the drug industry to make more appropriate drugs available to patients — not only for cancer, but for many other diseases and drug factors influenced by mutations.