) 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
) oncology drug - Vectibix.
Following the news, Qiagen's share price increased 1.8% to close at
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
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
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
Both Amgen and Qiagen currently hold a Zacks Rank #3 (Hold). Some
better-ranked stocks worth considering in the med-biomed/generic
Myriad Genetics Inc.
). Both the stocks sport a Zacks Rank #1 (Strong Buy).
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