Biocartis Gets CE Marking for Two Colorectal Cancer Liquid Biopsy Tests

NEW YORK (GenomeWeb) – Biocartis announced today that it has received CE-IVD marking for two liquid biopsy tests to detect RAS mutations in circulating tumor DNA from patients with metastatic colorectal cancer. The tests are the Belgian molecular diagnostics firm's first liquid biopsy assays to receive CE-IVD marking. 

The Idylla ctNRAS-BRAF Mutation Test detects 18 NRAS and five BRAF mutations, and the Idylla ctKRAS Mutation Test detects 21 KRAS mutations. The tests have turnaround times of 110 minutes and 130 minutes, respectively, require less than one minute of hands-on time, and run directly from one milliliter of patient blood plasma on Biocartis' real-time PCR Idylla platform, the firm said.

Biocartis also noted that validation studies performed for the CE-marking of the Idylla tests showed 88 percent concordance between blood plasma-based and tumor tissue-based testing in patients with detectable levels of ctDNA, who are typically mCRC patients with liver metastases. 

The RAS tests were developed as part of a collaboration with Merck KGaA aimed at improving diagnostic testing for patients with mCRC. Patients with RAS wild-type tumors have been shown to benefit from anti-EGFR therapies, such as Erbitux (cetuximab). The drug is marketed by Lilly in the US and Canada, and by Merck KGaA elsewhere. 

The companies will now collaborate to make the tests commercially available to medical centers, however Biocartis noted that the collaboration does not include the US, China, or Japan. Merck KGaA has a partnership for mCRC liquid biopsy development with Amoy Diagnostics in the Chinese market, and has partnered with Sysmex Inostics to develop a CE-marked test for Europe and Australia, with additional test sites planned for Asia and South America.

The Idylla platform along with a respiratory virus panel were granted 510(k) clearance by the US Food and Drug Administration earlier this year.