Biocartis, an innovative molecular diagnostics company, announced that it has officially launched its flagship molecular diagnostics system Idylla. Idylla’s unrivaled 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, chief executive officer, & 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 FFPE tissue slices is unique for BRAF testing. The excellent analytical sensitivity of the Idylla BRAF Mutation Test was demonstrated during clinical performance studies. Rudi Pauwels added: “Biocartis has the crucial expertise in house to bring a whole new generation of diagnostic tests for oncology and infectious diseases to the market. Furthermore, we are also working with Janssen Pharmaceutica and Abbott Molecular to develop a range of diagnostic tests in other disease areas.”“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 personalised therapy faster, ultimately improving treatment outcomes”, stated Rudi Pauwels.
Every person has a unique genetic profile. Understanding and leveraging the molecular mechanisms underlying diseases empowers doctors to shift away from the one-drug-fits-all paradigm and tailor a treatment to the genetic profile of their patient, also known as ‘personalised medicine’. Specific molecular diagnostics tests can, for instance, aid a doctor in the selection of the appropriate therapy for a melanoma patient whose tumour carries a specific genetic mutation. Eventually, this makes treatments more effective, improves outcomes and ultimately reduces healthcare costs. However, in order to be truly sustainable and beneficial, molecular information needs to be gathered quickly and easily, at the point of need. Today, this is not the case. Most hospitals do not perform molecular tests in-house, but send the test samples out to specialised labs where they are processed in batches, on multiple instruments and operated by highly trained personnel. This time-consuming and labor-intensive process delays treatment decisions which are often crucial to save patients’ lives.
Biocartis has developed a miniaturised, fully automated molecular system that integrates all molecular diagnostic steps in one easy-to-use system. Idylla offers clinicians fast and easy access to molecular diagnostics information, anywhere and anytime. It can be used for any human clinical sample type and covers the entire process from sample to result in a time frame of 35 to 120 minutes. Idylla enables clinical laboratories to perform a broad range of applications in oncology, infectious diseases and beyond. Idylla and the system’s first assay, the Idylla BRAF Mutation Test, have obtained CE-IVD marking.
About 50 per cent of melanoma patients harbour mutations in the BRAF oncogene. In more than 90 per cent of the cases, BRAF mutations are located in the BRAF V600 codon (V600E and V600K). Several therapies that treat cancers associated with BRAF mutations have been developed, showing response rates in up to half of metastatic melanomas. Tumour mutation status is usually assessed starting from formalin-fixed paraffin-embedded (FFPE) tumour tissue material. Currently the process for detecting BRAF mutations is labour-intensive, requiring multiple steps. Most labs do not perform these tests in-house, but send them to specialised laboratories, where samples are batched such that it often takes weeks before results are available.