Merck and Sysmex Inostics receive CE Mark approval for liquid biopsy test for colorectal cancer

Merck has announced that a new liquid biopsy RAS biomarker test, which they are co-developing and commercialising with Sysmex Inostics, has been granted CE Mark approval.

This test will now be made widely accessible for patients with metastatic colorectal cancer (mCRC) in Europe, Asia and Australia. The testing technology, OncoBEAM^® RAS CRC assay, has been shown to have a similar performance to that of conventional tissue-based testing^1–3 and can be used to determine which patients would benefit from anti-epidermal growth factor receptor (anti-EGFR) therapies, such as Erbitux^® (cetuximab), as demonstrated by recent data.^4–8

“In keeping with our philosophy of patient focus, we strive to evaluate all aspects of the patient journey, to focus our efforts on projects that improve treatment experience and outcomes for the patients,” said Rehan Verjee, Chief Marketing and Strategy Officer of Merck’s biopharma business. “The CE mark approval of the liquid biopsy RAS biomarker test is therefore a pivotal milestone for patients with metastatic colorectal cancer, as it allows for informed and rapid treatment decisions. We, with our partner Sysmex Inostics, can now start making this test available to more patients around the world.”

“We have achieved a significant milestone with the CE Mark of the OncoBEAM^® RAS colorectal cancer assay,” said Fernando Andreu, CEO of Sysmex Inostics. “Together with Merck, we are advancing biomarker testing in metastatic colorectal cancer, and we are already seeing strong acceptance and uptake of the test in pilot centres, with clinicians globally recognising the clinical value of a blood-based test.”

The liquid biopsy RAS biomarker test is a comprehensive 34-mutation panel that is based on the BEAMing (Beads, Emulsion, Amplification and Magnetics) technology. The test only requires a small blood sample (10ml), rather than a tissue biopsy, to determine the mutation status of tumours.⁹ The test has the potential to provide mutation status results within days, which can help guide quicker treatment decisions.⁹

”As the first test center to use the liquid biopsy RAS biomarker testing technology we have seen first-hand how this technology has advanced treatment decision-making,” said Professor Josep Tabernero, Director Head of the Medical Oncology Department of Vall d’Hebron University Hospital, Spain. “The speed at which the test results become available has helped us initiate effective treatments faster, which has led to improved patient outcomes.”

Merck and Sysmex Inostics entered into an agreement to co-develop and commercialise the liquid biopsy test on May 19, 2014 and opened the first test center, for research use only, at the Vall d’Hebron Institute of Oncology in Barcelona, Spain on February 20, 2015. Now with the CE Mark, the liquid biopsy RAS biomarker testing technology is expected to be widely implemented across Europe, Asia, Latin America and Australia by the end of 2016.

References

1. Hahn S et al. Eur J Cancer 2015;51(suppl 3):S79.
2. Jones S et al. Poster discussion presentation at the European Cancer Congress 2015, September 25–29, 2015.
3. Scott R et al. Ann Oncol 2015;16(suppl 4):iv1–iv100.
4. Douillard J-Y et al. N Engl J Med 2013;369(11):1023–34.
5. Schwartzberg LS et al. J Clin Oncol 2014;32(21):2240–7.
6. Bokemeyer C et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30–June 3, 2014. Abstract No:3505.
7. Stintzing S et al. Oral presentation at the European Society for Medical Oncology Congress, September 26–30 2014. Abstract No:LBA11.
8. Ciardiello F et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30–June 3, 2014. Abstract No:3506.
9. Diaz LA and Bardelli A. J Clin Oncol 2014;32(6):579−86.