Sysmex wins approval for RAS gene mutation testing in Japan
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Sysmex wins manufacturing approval for RAS gene mutation testing

05 Aug 2019 (Last Updated August 5th, 2019 11:31)

Sysmex has secured the first manufacturing and marketing approval in Japan for the OncoBEAM RAS CRC Kit, which is used for the blood-based circulating tumour DNA molecular testing of KRAS and NRAS gene mutations in patients with colorectal cancer.

Sysmex wins manufacturing approval for RAS gene mutation testing
OncoBEAM RAS CRC Kit is used to detect RAS gene mutations in genomic DNA extracted from plasma. Credit: © Sysmex Corporation.

Sysmex has secured the first manufacturing and marketing approval in Japan for the OncoBEAM RAS CRC Kit, which is used for the blood-based circulating tumour DNA molecular testing of KRAS and NRAS gene mutations in patients with colorectal cancer.

The company noted that the product is the first in vitro diagnostic reagent in the country to be used for RAS gene mutation testing using liquid biopsy.

The new OncoBEAM is simpler, minimally invasive, and provides detection results on a par with the use of tumour tissue.

It is capable of reducing the physical and mental burden on patients as well as expanding testing opportunities. It also contributes to the determination of treatment methods at an early stage.

OncoBEAM is used to test samples of tumour-derived DNA suspended in the blood of colorectal cancer patients.

As the approach uses BEAMing technology to provide auxiliary test data for the appropriateness of molecularly targeted drugs Cetuximab and Panitumumab for patients with colorectal cancer, doctors will also be able to determine treatment methods.

OncoBEAM, which received CE Marking certification in March 2016, was developed by Merck and the company’s subsidiary Sysmex Inostics.

For the approval of the method as an in vitro diagnostic reagent in Japan, eight medical facilities were involved in a multi-facility evaluation, including the National Cancer Center Hospital East.

Sysmex plans to launch the OncoBEAM RAS CRC Assay Service for colorectal cancer using a liquid biopsy to detect RAS gene mutations in the blood, at the Sysmex IMP laboratory in the Kobe Biomedical Innovation Cluster.