Download News Release Merck and AmoyDx Collaborate to Bring Liquid

News Release
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Rimmi Harindran
+49 6151 72-32843
Merck and AmoyDx Collaborate to Bring Liquid
Biopsy RAS Biomarker Testing to China
•
Liquid biopsy RAS biomarker test based upon AmoyDx’s real-time
PCR technology, ADx-SuperARMS®, will be made available in China
in 2017
•
Merck is the first pharmaceutical company to collaborate with
multiple diagnostic providers to support liquid biopsy RAS
biomarker testing worldwide
Darmstadt, Germany, July 28, 2016 – Merck, a leading science and technology
company, today announced that it has signed a new collaboration agreement with
Xiamen based Amoy Diagnostics Co., Ltd. (AmoyDx) for the development and
commercialization of a new liquid biopsy RAS biomarker test for patients with
metastatic colorectal cancer (mCRC). The test will be developed using AmoyDx
real-time polymerase chain reaction (PCR) technology, ADx-SuperARMS®, and will
be made available in China in 2017.
The ADx-SuperARMS (AmoyDx-Super-Amplification-Refractory Mutation System)
technology is designed to support clinical practice in performing specific genemutation analysis; the liquid biopsy RAS biomarker 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
KRAS, NRAS and BRAF along with other mutations and gene signatures.1
“It is now well accepted within the oncology community that understanding the
individual RAS biomarker status of metastatic colorectal cancer patients is key to
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News Release
supporting timely treatment decision-making, and results of the recent TAILOR
study in China further support the efficacy of targeted therapies such as
cetuximab in RAS wild-type patients,” said Rehan Verjee, Chief Marketing and
Strategy Officer of Merck’s biopharma business. “China is a key market for us, and
our collaboration with AmoyDx will support our goal of improving care for patients
with metastatic colorectal cancer, by providing access to state-of-the-art, reliable
and accurate testing technology to enable a higher standard of care in China.”
ADx-SuperARMS is an innovative mutation detection technology developed by
AmoyDx, and is one of the key technologies recommended by the Consensus
Group for KRAS Gene Mutation Detection in Colorectal Carcinoma (part of the
China Pathology Quality Control Center)2. ADx-SuperARMS detects mutations in
blood samples that contain as little as 0.2% mutant DNA in a background of wildtype genomic DNA. The ADx-SuperARMS test is designed to offer highly accurate
molecular diagnostic screening for clinical practices;1 cards pre-loaded with PCR
reagents mean a faster, more sensitive and easier to operate protocol than
traditional gene sequencing approaches. The test requires a single patient blood
sample to perform a RAS mutation analysis and can provide results in 120
minutes,1 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 decisionmaking and make a difference to patients with metastatic colorectal cancer,” said
Dr. Li-Mou Zheng, CEO of AmoyDx. “As our understanding of personalized
medicine evolves, we are excited that we are able to collaborate with Merck, to
offer an extension to our ADx-SuperARMS testing technology capabilities that will
see RAS biomarker testing available in Asia and more markets around the world.”
Merck and AmoyDx plan to implement the ADx-SuperARMS liquid biopsy RAS test
in Chinese medical centers in 2017, with a plan to expand into other markets such
as Argentina, India, Mexico, Taiwan, Hong Kong, Brazil, and Russia by 2019. The
test will be available initially for Research Use Only (RUO) and AmoyDx will submit
the assay for CE Mark Approval in 2016. A concordance study will also be
undertaken to verify the accuracy of the test, compared with existing tissue-based
methodologies.
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News Release
About mCRC
Approximately half of patients with mCRC have RAS wild-type tumors and half have RAS mutant
tumors.2 Results from studies assessing RAS mutation status in patients with mCRC have shown that
anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies, such as Erbitux®
(cetuximab), can improve outcomes in patients with RAS wild-type mCRC.3-6 Colorectal cancer (CRC) is
the third most common cancer worldwide, with an estimated incidence of more than 1.36 million new
cases annually.7 An estimated 694,000 deaths from CRC occur worldwide every year, accounting for
8.5% of all cancer deaths and making it the fourth most common cause of death from cancer.7 Almost
55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates
are substantially higher in men than in women.7
References
1. AmoyDx. About Us. Available from: http://www.amoydx.com//en/about.html. Accessed May
2016.
2. Liang ZY. Zhonghua Bing Li Xue Za Zhi 2012;41(9):635–6.
3. Vaughn CP et al. Genes Chromosomes Cancer 2011;50(5):307−12.
4. Bokemeyer C et al. J Clin Oncol 2014; 32:(Suppl 4): abstr 3505.
5. Van Cutsem E et al. J Clin Oncol 2015;33(7):692–700.
6. Stintzing S et al. Oral presentation at the 2014 European Society for Medical Oncology
Congress, September 26–30, 2014. Abstract No:LBA11.
7. Lenz H et al. Ann Oncol 2014;25(Suppl 5):v1–41.
8. Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM,
Forman D, Bray F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC
CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer.
2013. Available from: http://globocan.iarc.fr. Accessed May 2016.
About AmoyDx
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 tumour 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.
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About Merck
Merck is a leading science and technology company in healthcare, life science and performance
materials. Around 50,000 employees work to further develop technologies that improve and enhance
life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for
scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015,
Merck generated sales of €12.85 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding
family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany
holds the global rights to the Merck name and brand. The only exceptions are the United States and
Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
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