Companion Diagnostics for Cancer Drugs Advancing Personalized Medicine

1/31/13Follow @cathyarnst

The medical world took little notice earlier this month when Qiagen (NASDAQ: QGEN), a German maker of diagnostics equipment, asked the Food & Drug Administration to approve its test for a certain gene mutation associated with lung cancer. The mutation, involving the epidermal growth factor receptor (EGFR) found on the surface of cells, plays an important role in the rapid spread of tumor cells and is found in about 10 percent to 15 percent of Caucasians and 40 percent of Asians with non-small cell lung cancer.

This may all sound pretty esoteric, but Qiagen’s filing is in the vanguard of a major change in the way cancer drugs are being developed—and a critical step towards the long-awaited era of personalized medicine. Qiagen’s FDA application was made in tandem with a filing by Boehringer Ingelheim, another German company with a large U.S. operation in Ridgefield, CT, for its lung cancer drug afatinib, which targets the EGFR mutation. Indeed, the test and drug were developed in tandem, and Qiagen and Boehringer want the FDA to approve them both simultaneously.

The tests in these sorts of pairings are called companion diagnostics, and they are meant to determine if a patient should receive a particular drug, or how much of the drug should be administered. A number of diagnostic and pharma companies with a presence in the Northeast are, like Qiagen and Boehringer, forging partnerships to develop drugs and companion diagnostics simultaneously—more on this below. Qiagen, whose U.S. headquarters are in Gaithersburg, MD, has more than 15 projects underway to co–develop companion diagnostics, many of them with some of the biggest pharma companies, such as New York-based Pfizer (NYSE: PFE).

Such tests aren’t new, certainly. Roche’s Herceptin, prescribed for women with HER2-positive breast cancer, was the first cancer drug … Next Page »

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