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The number of adults in the U.S. who have ever been diagnosed with cancer totals 18.6 million, or 8.2 percent. Diagnostic tests are widely used to screen for various types of cancer, such as Pap smears for cervical cancer. Increasingly, advanced diagnostic tests are being used to determine the most appropriate treatments for a specific patient.

Recent advances in the field have included approval by the Food and Drug Administration (FDA) of two companion diagnostic tests in 2011. Companion diagnostics are tests that provide information about genomic and proteomic characteristics to help inform use of a specific drug or therapy.

  • FDA approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, and a companion diagnostic test manufactured by Roche Molecular Systems called the cobas 4800 BRAF V600 Mutation Test. The companion diagnostic will determine whether a patient’s melanoma cells have the BRAF V600E mutation and therefore if the patient is a good candidate for Zelboraf.
  • FDA approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers who express the abnormal anaplastic lymphoma kinase (ALK) gene. Xalkori was approved with a companion diagnostic test, the Vysis ALK Break Apart Fluorescence In Situ Hybridization Kit manufactured by Abbott Molecular, which determines if a patient has the abnormal ALK gene.