A fully automated real-time PCR based molecular diagnostics system and a dedicated assay that identifies cancers driven by the BRAF oncogene recently received European CE marking certification.

The recently launched Biocartis (Mechelen, Belgium) Idylla instrument is the backbone of the company's flagship molecular diagnostics system. Along with Idylla, Biocartis also released the Idylla BRAF Mutation Test for detection of mutations in the BRAF oncogene.

The BRAF (v-Raf murine sarcoma viral oncogene homolog B1) gene encodes the protein serine/threonine-protein kinase B-Raf. About half of melanomas express the BRAFV600E mutation (at amino acid position number 600 on the B-Raf protein, the normal valine is replaced by glutamic acid). Inhibitors of B-Raf such as vemurafenib have been approved for the treatment of metastatic melanoma since August 2011. In addition to melanoma this mutation has been widely observed in papillary thyroid carcinoma and colorectal cancer.

The Idylla system is expected to establish a new standard for molecular diagnostic testing. The instrument'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. Idylla utilizes liquid-tight, disposable cartridges that reduce of risk of contamination and eliminate the necessity for separate pre- or post-PCR labs.

The BRAF Mutation Test is Idylla’s first oncology test and is designed to determine the most appropriate treatment for specific types of skin cancer. The assay can detect mutations directly from formalin-fixed paraffin-embedded (FFPE) tissue slices in about 90 minutes. This direct processing of FFPE tissue slices was cited as being unique for BRAF testing.

“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 of Biocartis. “Traditionally, molecular diagnostics involves a series of specialized, labor-intensive, and time-consuming steps. As a result, most labs do not perform these tests in-house, but send them to specialized labs where they are batched, often delaying treatment decisions. We are convinced that Idylla will completely transform the day-to-day practice in molecular labs, making molecular testing more straightforward than ever imagined. This will significantly speed up the diagnostic process and will enable doctors to make therapy decisions in a much shorter time frame. Ultimately, patients will receive a personalized therapy faster, ultimately improving treatment outcomes.”

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