Merck and AmoyDx Collaborate to Bring Liquid Biopsy RAS Biomarker Testing to China

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DARMSTADT, Germany, July 28, 2016 / PRNewswire=KYODO JBN / --

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    - Liquid biopsy RAS biomarker test based upon AmoyDx's real-time PCR

technology, ADx-SuperARMS(R), 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

    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(R), 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

    1) AmoyDx. About Us. Available from: http://www.amoydx.com//en/about.html.

Accessed July 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 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(R) (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 EUR12.85 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