November 2014—Biocartis announced the launch of its flagship molecular diagnostics system, Idylla. With Idylla, Biocartis also released its first oncology assay, the Idylla BRAF Mutation Test. Both Idylla and the Idylla BRAF Mutation Test have obtained CE-IVD marking.
Idylla is a fully automated, real-time PCR system that allows clinicians to initiate a new test at any time, without the need for batching or for trained operators. The system’s short turnaround time—between 35 and 120 minutes—enables laboratories to report same-day results. The system’s multiplex capability can detect up to 30 molecular targets simultaneously in the same sample, making the system suitable for more complex assays.
The BRAF Mutation Test is Idylla’s first oncology test and is designed to determine the most appropriate treatment for a specific type of skin cancer. The assay can detect mutations directly from formalin-fixed, paraffin-embedded tissue slices in about 90 minutes. This direct processing of FFPE tissue slices is unique for BRAF testing, the company said in a statement. The analytical sensitivity of the BRAF Mutation Test was demonstrated during clinical performance studies.
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