QIAGEN receives regulatory approval in Japan for EGFR companion diagnostic to guide cancer treatments
- therascreen® EGFR Mutation Detection Kit RGQ approved in Japan, one of the leading markets for pairing diagnostics with drug therapies in personalized healthcare
- QIAGEN assay detects genetic mutations to identify patients likely to experience efficacy with EGFR-inhibitor drugs targeting Non-small Cell Lung Cancer
- Adds further important approval to QIAGEN's portfolio of companion diagnostics
QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced the regulatory approval of its therascreen® EGFR Mutation Detection Kit RGQ in Japan. EGFR, the epidermal growth factor receptor, has been shown to play an important role in certain cancers and is the target of many new anticancer drugs.
The approval is a milestone in QIAGEN's Personalized Healthcare strategy, as Japan is one of the world's largest markets for companion diagnostic tests. In April 2011, QIAGEN's therascreen® KRAS Mutation Detection Kit was approved in Japan, targeting a different biomarker that is also used to guide cancer treatment decisions. The potential patient population alone in Japan for EGFR and KRAS testing is estimated at approximately 100,000 per year.
"Greater use of companion diagnostic tests such as our EGFR and KRAS assays may help overcome significant challenges by maximizing the efficacy and safety of therapies and improving patient outcomes," said Dr. Stephen Little, Vice President Global Personalized Healthcare at QIAGEN. "Japanese and other East Asian populations generally have a higher rate of EGFR mutations than other groups, and non-smoking East Asian women are the largest potential market for EGFR-inhibitor anticancer drugs. This approval allows QIAGEN to market our companion diagnostic along with major pharmaceutical companies offering certain EGFR-inhibitor drugs. The approval of therascreen EGFR exemplifies our strategy of driving dissemination of molecular technologies by creating innovative test content and providing efficient, automated platforms for hospitals and laboratories to use these tests."
Companion diagnostic tests targeting EGFR, like QIAGEN's therascreen EGFR Mutation Detection Kit RGQ, determine the presence or absence of an EGFR mutation in a patient's tumor. Individuals, for whom treatment decisions are made following determination of EGFR mutation status, can experience 60% response rates to EGFR-inhibitor drugs, a much higher success rate than with traditional chemotherapy, studies show. Conversely, other patients can be unresponsive to EGFR-inhibitor drugs. Using the companion diagnostic not only may improve therapeutic outcomes, but also save patients and healthcare systems a significant amount of money since the newer classes of drugs can cost tens of thousands of dollars. By determining EGFR mutation status, doctors can prescribe the relevant drugs only to patients who are expected to benefit from them.
QIAGEN is the world's leading independent provider of molecular technologies for personalized healthcare, currently offering more than 30 assays that include tests for the biomarkers KRAS, BRAF and PI3K. QIAGEN is expanding its presence in the personalized healthcare field through regulatory submissions, such as two completed in mid-2011 in the U.S. for the KRAS biomarker, that are the result of an extensive range of research and development partnerships. In 2011, QIAGEN also acquired the French diagnostics company Ipsogen, gaining rights to a portfolio of biomarkers, including JAK2 and BCR-ABL, that are believed to play a role in various blood cancers.
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results are forward-looking, such statements are based on current expectations that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations and risks of dependency on logistics), variability of operating results, the commercial development of the applied testing markets, clinical research markets and proteomics markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's products (including fluctuations due to the level and timing of customers' funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products, the ability of QIAGEN to identify and develop new products and to differentiate its products from competitors' products, market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).
QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. As of September 30, 2011, QIAGEN employed nearly 3,800 people in over 35 locations worldwide. Further information about QIAGEN can be found at www.qiagen.com.