· Blood-based EGFR mutation testing with AmoyDx’s novel and highly sensitive real-time PCR technology, SuperARMS®, will be made available in China in 2017.
· Boehringer Ingelheim, as one of EGFR-TKI providers, is determined to collaborate with leading molecular diagnostic provider like AmoyDx to support blood-based EGFR mutation testing in China.
Xiamen, China, January 10, 2017–Boehringer Ingelheim, a global, research-driven pharmaceutical company, today announced that it has signed a new collaboration agreement with AmoyDx for the commercialization of a new blood-based EGFR mutation test for patients with advanced non-small cell lung cancer (NSCLC). The test is developed using AmoyDx real-time polymerase chain reaction (PCR) technology, SuperARMS®, and will be made available in China in 2017.
The SuperARMS® (Super Amplification-Refractory Mutation System) technology is designed to support clinical practice in performing specific gene-mutation analysis using circulating tumor DNA from blood samples; the blood EGFR mutation test is easy to perform, provides results within 120 minutes, and has been validated on several PCR platforms that are commonly used in diagnostic laboratories, when assessing for mutations in exons 18~21 of EGFR gene.1
“It is now well accepted within the oncology community that understanding the full EGFR mutation status of advanced non-small cell lung cancer patients is key to supporting timely treatment decision-making,” said Dirk van Niekerk, General Manager of Greater China Region for Human Medicines. “Results of the recent LUX-Lung 7 study further demonstrate the efficacy of Afatinib2, which has been submitted for approval in China, and received priority approval in April last year. Blood-based EGFR mutation testing as a non-invasive approach makes the EGFR mutation detection available to all of the advanced NSCLC patients before consideration for Afatinib treatment. China is a key market for us, and our collaboration with AmoyDx will further strengthen our goal of improving care for patients with advanced NSCLC.”
SuperARMS® is an innovative mutation detection technology developed by AmoyDx, and is one of the key technologies used for liquid biopsy EGFR mutant detection in lung cancer. SuperARMS® detects mutations in blood samples that contain as little as 0.2% mutant DNA in a background of wild-type genomic DNA. The SuperARMS® test is designed to offer highly sensitive and accurate molecular diagnosis for clinical practices. The test requires only one tube of blood sample to perform an EGFR mutation analysis and can provide results in 120 minutes, which will enable clinicians to make treatment decisions in a timely manner.
“At AmoyDx, we pride ourselves on providing highly reliable and effective diagnostic solutions to clinical practices, which will help inform clinical decision-making and make a difference to patients with advanced NSCLC,” said Dr. Limou Zheng, CEO of AmoyDx. “We are excited that we are able to collaborate with Boehringer Ingelheim, with our blood-based mutation testing technologySuperARMS®, we will jointly be able to significantly increase the EGFR mutation testing rate for patients with NSCLC in China.”
Boehringer Ingelheim and AmoyDx plan to implement the blood-based SuperARMS® EGFR test in China medical centers in 2017. The test will be available initially for Research Use Only (RUO) and AmoyDx will submit the assay for CFDA Approval in 2017.
Approximately 35%–40% among Chinese patients with advanced NSCLC have EGFR mutant tumors3. Results from studies assessing EGFR mutation status in patient with advanced NSCLC have shown that EGFR-TKI therapies, such as Gilorif (afatinib), can improve outcomes in patients with EGFR-mut NSCLC2,3. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer (about 85%), with an estimated incidence of 733.3 thousands new cases, and an estimated 610.2 thousands deaths in China every year4.
3. E-E Ke and Yi-Long Wu,* Trends in Pharmacological Sciences, 2016, 37(11):887-903
4. Chen W, Zheng R, CA Cancer J Clin 2016 Jan 25; [Epub ahead of print] PMID: 26808342
Amoy Diagnostics Co., Ltd. (AmoyDx) is the pioneer in leading the technology development and industrialization of molecular diagnostics of Chinese oncology precision medicine. AmoyDx is the biggest provider of oncology molecular diagnostic products and personalized testing services in China, as well as a service center of tumor biomarker analysis. We have a market-leading portfolio of molecular diagnostics, and have been the partner of several major pharmaceutical companies. For more information, please visit our website: www.amoydx.com.
About Gilorif (Afatinib)
Afatinib is a drug approved in United States, Europe, Taiwan,China, Mexico, Chile and Japan as well as other countries for the first-line treatment of patients with distinct types of metastatic (EGFR mutation positive) non-small cell lung carcinoma (NSCLC), developed by Boehringer Ingelheim. It acts as an irreversible covalent inhibitor of the receptor tyrosine kinases epidermal growth factor receptor (EGFR) and erbB-2 (HER2).
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 145 affiliates and a total of around 47,500 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.