Qiagen's therascreen KRAS Gets FDA Nod - Analyst Blog

Qiagen NV's QGEN clinically proven therascreen KRAS RGQ PCR Kit recently received the U.S. Food and Drug Administration (FDA) approval to identify and guide the treatment of metastatic colorectal cancer patients using Amgen Inc.'s AMGN oncology drug – Vectibix.

Following the news, Qiagen's share price increased 1.8% to close at $22.98 yesterday.

This FDA sanction marks the third U.S. approval for the use of a Qiagen companion diagnostic test in combination with a specific drug. This regulatory nod has naturally improved Qiagen's global leadership position in molecular companion diagnostics for personalized healthcare. The company's global portfolio now covers more than 25 molecular tests that target various companion diagnostic biomarkers.

Management believes that the company's collaboration with Amgen reflects Qiagen's capacity to serve as a preferred partner of pharmaceutical and biotech companies for co-development and commercialization of companion diagnostics. Moreover, the constant rollout of standardized, regulatory-approved tests has also added value to the company's Rotor-Gene Q MDx – a real-time PCR platform in the revolutionary QIAsymphony family.

Close to 40% of colorectal cancer patients have tumors with mutated forms of the KRAS gene which can influence response to anti-EGFR therapies such as Vectibix and Erbitux. The therascreen KRAS test, when used in the screening of colorectal cancer patients, can help detect the most frequent mutations in the KRAS gene. It also facilitates better treatment decisions for both physicians and patients.

This year itself, Qiagen launched its therascreen IDH1/2 RGQ Kit in Europe to guide the treatment of patients with gliomas. The company has also received an approval in China for the therascreen EGFR test for use in the treatment of non-small cell lung cancer (NSCLC), making it the company's first companion diagnostic in China. Qiagen already markets therascreen assays in Europe for biomarkers including KRAS, EGFR, NRAS, BRAF, PI3K, JAK2, MGMT, UGT1A1 and many others.

At present, Qiagen is co-developing the industry's widest range of companion diagnostics under more than 20 project agreements with pharmaceutical and biotech companies, including 5 master collaboration agreements.

Both Amgen and Qiagen currently hold a Zacks Rank #3 (Hold). Some better-ranked stocks worth considering in the med-biomed/generic industry are Myriad Genetics Inc. MYGN and Illumina Inc. ILMN. Both the stocks sport a Zacks Rank #1 (Strong Buy).
 

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