Not intended for UK- or US-based media
- 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 /CNW/ - 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 gene-mutation 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 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 wild-type 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 decision-making 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.
References
- AmoyDx. About Us. Available from:
http://www.amoydx.com//en/about.html. Accessed July 2016.
- Liang ZY. Zhonghua Bing Li Xue Za Zhi 2012;41(9):635-6.
- Vaughn CP et al. Genes Chromosomes Cancer
2011;50(5):307−12.
- Bokemeyer C et al. J Clin Oncol 2014; 32:(Suppl 4): abstr
3505.
- Van Cutsem E et al. J Clin Oncol 2015;33(7):692-700.
- Stintzing S et al. Oral presentation at the 2014 European
Society for Medical Oncology Congress, September 26-30, 2014. Abstract No:LBA11.
- Lenz H et al. Ann Oncol 2014;25(Suppl 5):v1-41.
- 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 July
2016.
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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]
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: http://www.amoydx.com.
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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SOURCE Merck