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Merck KGaA, Sysmex Inostics Garner CE Mark for Liquid Biopsy CRC Test

This article has been updated with additional details about analysis Sysmex performed on the OncoBEAM RAS CRC test's concordance with tissue-based tests.

NEW YORK (GenomeWeb) – Merck KGaA and Sysmex Inostics have garnered a CE Mark for the OncoBEAM RAS CRC, a blood test the companies are developing and commercializing together.

The firms now plan to market the test in Europe, Asia, and Australia as a tool oncologists can use to determine which metastatic colorectal cancer patients have RAS mutations and would likely benefit from EGFR inhibitors, such as Erbitux (cetuximab). The drug is marketed by Lilly in the US and in Canada, and by Merck KGaA outside these territories.

Around 50 percent of metastatic colorectal cancer patients have mutations in RAS. Sysmex CEO Fernando Andreu stated that the company has already seen strong uptake of the test at pilot centers.

Following a 2014 deal, Merck began working with Sysmex to develop the 34 mutation panel based on Sysmex's emulsion-based digital PCR technology, called BEAMing, which stands for beads, emulsions, amplification, and magnetics.

According to the companies, the test requires 10 ml of blood and yields results in a couple of days. According to an abstract published in the Annals of Oncology, Sysmex has also assessed the concordance of its blood test against traditional tissue-based analysis by Sanger and pyrosequencing, and found 93.5 percent concordance across 31 paired samples.

A spokesperson for Sysmex told GenomeWeb that in order to garner the CE Mark, the company looked at the concordance between OncoBEAM RAS CRC and tissue-based tests in more than 240 paired samples. The spokesperson did not provide additional details, which will be presented at a major medical conference later this year.

Last year, Merck and Sysmex began offering OncoBEAM RAS CRC for research use at the Vall d'Hebron Institute of Oncology in Barcelona, Spain.

"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 Josep Tabernero, who leads the oncology department at the Vall d'Hebron University Hospital. "The speed at which the test results become available has helped us initiate effective treatments faster, which has led to improved patient outcomes."

 

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