Molecular Diagnostics System and BRAF Mutation Test Launched  

Biocartis have announced that it has officially launched its flagship molecular diagnostics system Idylla™. Idylla™’s unrivalled ease of use, access on-demand design, speed and superior sensitivity are unprecedented in the field of molecular diagnostics. Together 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.

“Molecular testing plays a key role in the treatment decision process. It allows doctors to select specifically designed therapies based on the genetic profile of their patient”, said Rudi Pauwels, CEO and Executive Chairman of Biocartis. “Traditionally, molecular diagnostics involves a series of specialised, labour-intensive and time-consuming steps. As a result, most labs do not perform these tests in-house, but send them to specialised labs where they are batched, often delaying treatment decisions.”

Idylla™, Biocartis’ fully automated, real-time PCR system, sets the standard for a novel way of molecular testing. Idylla™’s access on-demand design allows clinicians to initiate a new test at any given 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, significantly speeding up the treatment decision process. Furthermore, Idylla™’s multiplex capability offers the possibility to detect up to 30 molecular targets simultaneously in the same sample, making the system very well suited 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 FFPE tissue slices in about 90 minutes. This direct processing of FPE tissue slices is unique for BRAF testing. The excellent analytical sensitivity of the Idylla™ BRAF Mutation Test was demonstrated during clinical performance studies.