Recently, Qiagen (NasdaqGS: QGEN - News) entered into an agreement with Pfizer Inc. (NYSE: PFE - News) to develop a companion molecular diagnostic test for use with an investigational Pfizer compound for treating non-small cell lung cancer (NSCLC). Financial terms of the deal were not disclosed. The proposed test will use the same core assay component as Qiagen’s proprietary KRAS assay technology, which detects mutations of the KRAS gene, frequently found in human colorectal cancers.
Earlier this month, Qiagen opted for the pre-market approval from US Food and Drug Administration (FDA) for KRAS companion diagnostics for use with two other separate drugs targeting metastatic colorectal cancers. Through this partnership, Qiagen expects to develop the KRAS companion diagnostic for use with dacomitinib (PF-00299804). This partnership will also cover clinical trials and submissions for a pre-market approval application in the US and the CE mark in Europe, as well as approvals in other regions.
Companion diagnostics are currently gaining significant traction and peers of Qiagen like Myriad Genetics (MYGN'>MYGN) are establishing themselves as strong players in the companion diagnostics market. However, this latest move on Qiagen’s part is e xpected to strengthen its foothold in this market by combining its excellence in companion diagnostics with Pfizer's scientific and global background while developing innovative diagnostic-therapeutic care with the potential to improve the treatment of NSCLC patients.
The molecular diagnostics segment of Qiagen contributed to 46% of total sales in the second quarter of fiscal 2011 and registered a 2% growth at constant exchange rate (CER) on the back of solid growth in consumable products, partially offset by lower instrument sales. However, the comparison was hampered by higher one-time contributions in the prior-year quarter, which included payments for companion diagnostic co-development projects to pharmaceutical companies.
Going forward, the company expects a wave of newly discovered biomarkers and companion diagnostics to transform the treatment of a number of diseases.