Sysmex Inostics has announced that its OncoBEAM® RAS CRC test has been granted CE Mark approval. The test, developed by Sysmex Inostics GmbH in collaboration with Merck, can now be accessed by patients with metastatic colorectal cancer (mCRC) across Europe. The OncoBEAM® RAS CRC assay has been shown to have similar performance to conventional tissue-based testing1-3 and can be used to determine which patients would benefit from anti-EGFR therapies, such as Erbitux, as demonstrated by recent data.4-8
"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 centers, with clinicians globally recognizing the clinical value of a blood-based test."
"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."
The highly sensitive OncoBEAM® RAS CRC test is a simplified method for determining the RAS mutation status of tumors, which requires only a single blood-draw. Thus, the test has the potential to provide mutation status results within days, which can help guide quicker treatment decisions. Moreover, the blood-based test is an alternative to tissue biopsies or other surgical procedures, and can also be performed when no tumor tissue is available or a rapid test result is crucial for therapy success.9
"As the first test center to use the liquid biopsy RAS biomarker testing technology we have seen firsthand 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."
The OncoBEAM® RAS assay is a comprehensive test which includes 34 KRAS and NRAS mutations reflecting the recommendations of the NCCN, ESMO as well as EMA guidelines to determine the RAS mutation status before initiating treatment.10-13 Now with the CE Mark, it is expected to be widely implemented across Europe, Asia, Latin America, and Australia by the end of 2016. OncoBEAM® is a registered trademark of Sysmex Corporation. OncoBEAM® is distributed and marketed by Sysmex Inostics, Hamburg, Germany.