Merck and Biocartis to Collaborate on New Liquid Biopsy Technology for RAS Biomarker Testing

PR63015

DARMSTADT, Germany, Jan. 7, 2016/PRNewswire=KYODO JBN / --

    - Merck becomes first pharmaceutical company to collaborate with multiple

      diagnostic providers to support RAS biomarker testing

    - Collaboration allows Merck to provide complementary molecular testing

      solutions to various laboratory segments  

    - Biocartis' fully automated Idylla(TM) system will enable more clinics to

      assess RAS mutation status in metastatic colorectal cancer (mCRC)

      patients

    - New diagnostic test will be fast, minimally invasive, easy-to-perform

      and support timely decision making

    Merck, a leading science and technology company, today announced that it

has signed a collaboration agreement with Biocartis 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 on Biocartis'

innovative, fully automated molecular diagnostics system, Idylla(TM), which is

designed to offer accurate and reliable molecular information from virtually

any biological sample in virtually any setting. The new test aims to support

clinical practice in performing integrated liquid biopsy RAS biomarker tests,

independently of the laboratories' volume of testing or level of expertise.

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    Understanding metastatic colorectal cancer (mCRC) patients' individual

biomarker status is key to support timely treatment decision-making.

    "Through this collaboration, our desire is to have more metastatic

colorectal cancer patients gain access to liquid biopsy RAS testing, regardless

of their geographical location," said Rehan Verjee, Chief Marketing and

Strategy Officer of Merck's biopharma business. "As the first pharmaceutical

company to collaborate with multiple diagnostic providers of liquid biopsy RAS

testing, we are living our commitment to supporting patients and physicians by

going beyond treatment. The Biocartis technology will be complementary to other

technology previously developed, and will allow for liquid biopsy RAS offerings

to a wide range of lab segments, regardless of size and expertise levels."

    The Idylla(TM) system is a fully automated sample-to-result PCR-based

(polymerase chain reaction) molecular diagnostics system. It is designed to

offer real-time, reliable and sensitive molecular diagnostic tests. Whereas

most of today's solutions only look for the most prevalent RAS mutations, the

Idylla(TM) RAS test, comprising two Idylla(TM) cartridges, will be designed to

detect an extended panel of RAS mutations. In addition, the new test will also

provide a BRAF V600 mutation analysis directly integrated with the Idylla(TM)

RAS test, to allow clinicians to evaluate BRAF and RAS mutation status

simultaneously. Based on a direct sample of only 2 ml of blood plasma, the test

aims to provide high sensitivity and ease-of-use. The test will be designed to

require less than 2 minutes of hands-on time and a turnaround time of

approximately 2 hours, enabling clinical decision-making in a timely manner.

    "Today, complex diagnostic laboratory infrastructure and specialized

expertise requirements are important barriers when it comes to the

implementation of personalized medicine on a global scale," said Rudi Pauwels,

CEO Biocartis. "We are pleased to partner with Merck, who supports us in

putting personalized medicine into daily practice with this collaboration,

through the development of rapid and accurate tests on the Idylla(TM)

system. After having already launched solid biopsy RAS tests, the Idylla(TM)

liquid biopsy RAS test is a logical next step in our rapidly expanding menu of

oncology tests."

    Merck and Biocartis plan to implement the Idylla(TM) liquid biopsy RAS test

in numerous medical centers across the world, excluding the U.S., China and

Japan. The test will be available for Research Use Only (RUO) in H2 2016 and is

shortly thereafter planned to be submitted for a CE Mark. A concordance study

is currently also being undertaken to substantiate the value of the test.

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    About mCRC

    Approximately half of patients with mCRC have RAS wild-type tumors and half

have RAS mutant tumors.[1] 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.[2-6] 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) Vaughn CP, et al. Genes Chromosomes Cancer. 2011;50(5):307-12.

    2) Douillard J-Y, et al. N Engl J Med 2013;369(11):1023-34.

    3) Schwartzberg LS, et al. J Clin Oncol 2014; March 31 [Epub ahead of

       print]. Available online: http://www.ncbi.nlm.nih.gov/pubmed/24687833.

       Last accessed January 2016.

    4) Bokemeyer C, et al. Oral presentation at the 2014 American Society of

       Clinical Oncology Annual Meeting, May 30-June 3, 2014.

    5) Stintzing S, et al. European Cancer Congress 2013:Abstract No:LBA17.

    6) Ciardiello F, et al. Oral presentation at the 2014 American Society of

       Clinical Oncology Annual Meeting, May 30-June 3, 2014.

    7) 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 at: http://globocan.iarc.fr. Last accessed January 2016.

    About Biocartis  

    Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics

(MDx) company providing next generation diagnostic solutions aimed at improving

clinical practice for the benefit of patients, clinicians, payers and industry.

Biocartis' proprietary MDx Idylla(TM) platform is a fully automated

sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers

accurate, highly reliable molecular information from virtually any biological

sample in virtually any setting. Idylla(TM) addresses the growing demand for

personalized medicine by aiming to allow fast and effective treatment selection

and treatment progress monitoring. Biocartis launched the Idylla(TM) platform

commercially in September 2014 together with its first assay to identify BRAF

Mutations in metastatic melanoma. Its second assay, a KRAS Mutation panel for

colorectal cancer, was launched in June 2015. Biocartis is developing and

marketing a rapidly expanding test menu addressing key unmet clinical needs in

oncology and infectious diseases. These areas represent respectively the

fastest growing and largest segments of the MDx market worldwide. Further

information can be found at: http://www.biocartis.com.

    About Idylla(TM)

    Idylla(TM), Biocartis' fully automated, real-time PCR based molecular

diagnostics system, is designed to offer fast and easy access to clinical

molecular diagnostic information, anywhere and anytime. The Idylla(TM) platform

covers the entire process from sample to result in a time frame of 35 to 150

minutes with less than two minutes hands-on time. Idylla(TM) is applicable for

a wide range of clinical sample types and can analyze both RNA and DNA. The

fully integrated system enables clinical laboratories to perform a broad range

of applications in oncology, infectious diseases and beyond. The Idylla(TM)

system's first diagnostic tests, the Idylla(TM) BRAF Mutation Test for

metastatic melanoma, the Idylla(TM) KRAS Mutation Test for colorectal cancer

and the first infectious disease test, the Idylla(TM) Respiratory (IFV-RSV)

Panel developed in collaboration with Janssen Diagnostics, have obtained CE-IVD

marking. Further information can be found at: http://www.idylla.com.

    About Erbitux

    Erbitux(R) is a highly active IgG1 monoclonal antibody targeting the

epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of

action of Erbitux is distinct from standard non-selective chemotherapy

treatments in that it specifically targets and binds to the EGFR. This binding

inhibits the activation of the receptor and the subsequent signal-transduction

pathway, which results in reducing both the invasion of normal tissues by tumor

cells and the spread of tumors to new sites. It is also believed to inhibit the

ability of tumor cells to repair the damage caused by chemotherapy and

radiotherapy and to inhibit the formation of new blood vessels inside tumors,

which appears to lead to an overall suppression of tumor growth.

    The most commonly reported side effect with Erbitux is an acne-like skin

rash that seems to be correlated with a good response to therapy. In

approximately 5% of patients, hypersensitivity reactions may occur during

treatment with Erbitux; about half of these reactions are severe.

    Erbitux has already obtained market authorization in over 90 countries

world-wide for the treatment of colorectal cancer and for the treatment of

squamous cell carcinoma of the head and neck (SCCHN).

    Merck licensed the right to market Erbitux outside the US and Canada from

ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. Merck

has an ongoing commitment to the advancement of oncology treatment and is

currently investigating novel therapies in highly targeted areas.

    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 2014, Merck generated sales of EUR 11.3 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