The launch of the therascreen KRAS RGQ PCR Kit, which provides guidance on the use of Erbitux ® (cetuximab) as a treatment in patients with metastatic colorectal cancer, has been gaining momentum following the U.S. regulatory approval of this product in July 2012. A number of top U.S. laboratories have already adopted QIAGEN's FDA-approved test, which in many cases has replaced use of their own laboratory-developed tests (LDTs). The transition of many more U.S. laboratories is expected in the coming months. Approval of the KRAS test was a milestone in QIAGEN's global expansion of its Personalized Healthcare franchise, as entry into the U.S. market builds on success in Europe, Japan and other markets where QIAGEN already offers a broad range of Personalized Healthcare tests.
QIAGEN is actively expanding its pipeline in companion diagnostics and plans to submit several other tests for U.S. regulatory approval in the coming years. The next U.S. submission is planned for 2012 involving a therascreen EGFR assay as a companion diagnostic for use with Boehringer Ingelheim's investigational medicine afatinib in patients with non-small cell lung cancer (NSCLC).
Other submissions are expected to emerge from more than 15 projects QIAGEN has under way to co-develop and market companion diagnostics with leading pharmaceutical and biotech companies. In October, a new agreement was announced with Bayer HealthCare, laying the groundwork for a strong collaboration in oncology and other therapeutic areas based on existing and new biomarkers in the QIAGEN portfolio. This new collaboration with Bayer includes companion diagnostics to identify patients who are most likely to respond to therapies in clinically unmet disease classifications.
Growth in the third quarter of 2012 also benefited from novel content added through targeted acquisitions. Most recently, in May 2012 QIAGEN acquired AmniSure International LLC, a U.S. company that created the AmniSure ® assay, a highly sensitive and specific test for rupture of fetal membranes, a condition in pregnant women in which fluid leaks prematurely from the amniotic sac. This product, which is approved in the U.S. and many markets worldwide, is expected to be catalytic to QIAGEN's Point of Need portfolio and synergistic to its clinical sales channels. As announced with the acquisition in May, AmniSure is expected to contribute more than $12 million of sales to QIAGEN in 2012, but to be neutral to adjusted EPS as expansion investments are made.Broaden geographic presence