Study demonstrating Biocartis' BRAF liquid biopsy assay as good as more invasive tissue tests published in renowned journal of American Association for Cancer Research

PRESS RELEASE                                                                                

Study demonstrating Biocartis' BRAF liquid biopsy assay
is as good as more invasive tissue tests published in renowned journal of American Association for Cancer Research

Test can predict therapy response over the course of the cancer treatment

Mechelen, Belgium, 23 May 2016 - Biocartis Group NV ('Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the recent publication of a research study^[1] demonstrating that testing for BRAF V600 mutations in blood plasma is as good as more invasive tissue tests^[2]. The study by Dr. Filip Janku, PhD, assistant professor of Investigational Cancer Therapeutics at MD Anderson Cancer Center (Houston, US), was published in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR), the world's largest professional association related to cancer research. The press release of AACR announcing the publication of this study can be found here.

In this study, Dr. Janku and his team demonstrated that testing for BRAF V600 mutations in circulating tumour (ct)DNA from plasma, using Biocartis' Idylla(TM) ctBRAF Mutation Assay^[3], was concordant with standard tests using tumour tissue samples and could generate results in an unprecedented short turnaround time of 90 minutes. The study confirms that the Idylla(TM) ctBRAF Mutation Assay can act as a faster and minimally invasive substitute for invasive tissue biopsy testing in advanced cancers such as melanoma or colorectal cancers, which underlines that the test is perfectly suited for treatment monitoring.

Research over the last few years has shown that fragments of tumour DNA are shed into the blood from primary tumours or metastatic sites^[4]. These circulating DNA fragments can be used for diagnostic purposes, such as providing molecular information for treatment selection, or for monitoring disease progression in patients undergoing treatment. According to J.P. Morgan, the global market of liquid biopsy tests is estimated to reach $20 billion by 2020.

In the current study, plasma samples collected from 160 patients with a range of advanced cancers with known BRAF V600 mutation status were tested with the Idylla(TM) ctBRAF Mutation Assay³. Dr Janku and his team found that the test had 88 percent concordance with the results from the tissue tests that used solid, paraffin-embedded tissues, in samples collected at baseline. The concordance increased to 90 percent when results from samples collected at any time point during the course of the treatment were compared. The researchers also found that the amount of BRAF V600 mutant circulating tumour (ct)DNA, as detected by the Idylla(TM) platform³, was predictive of overall survival of the patients: in patients with a BRAF-mutant circulating tumor (ct)DNA percentage of 2 or less, overall survival was 10.7 months, compared with 4.4 months in those who had more than 2 percent of BRAF V600 mutations in their samples.