Biocartis
A New Realm in Molecular Diagnostics

The molecular diagnostics market has witnessed several breakthroughs over the last decade, providing clinicians with results that are easily obtained and accurate. As such, molecular applications have gradually transitioned from being manual and labor-intensive to rapid and automated owing to improvements in target amplification, sample extraction, and sensitive and specific detection schema. Keeping up with this evolution, Belgium-based Biocartis, an innovative commercial stage molecular diagnostics (MDx) company is providing next-gen diagnostic solutions in an ambitious bid to improve clinical practice for the benefit of patients, clinicians, and payers in the industry. To this end, the company has introduced its proprietary MDx Idylla platform, a real-time, fully automated system offering highly reliable, accurate molecular information from any biological sample in virtually any setting.

Addressing the growing demand for personalized medicine by allowing fast and effective treatment selection and treatment progress monitoring, Idylla is facilitating fast and actionable results. Further, to address the key unmet clinical needs in oncology and infectious diseases, Biocartis is also developing and marketing a rapidly expanding test menu.

Molecular Testing: Not a Hassle Anymore

The revolutionary PCR-based molecular testing system, Idylla is designed to deliver results in a minimum amount of time— 90-150 minutes turnaround time with less than two minutes hands-on time. The Idylla modular system can accommodate a lab’s throughput as it changes over the years. As an all-in-one system, Idylla comes loaded with all the consumables needed to perform sample preparation along with RT-PCR amplification and detection. Further, the disposable, liquid tight cartridges used in the significantly reduce the risk of contamination. Idylla brings forth two solutions—Idylla Connect and Idylla Explore—to ensure seamless continuity in laboratory workflow.

Idylla Connect comes with automatic software updates, whereby new releases of assay and console software are sent to the Idylla console and can be installed with a single touch on the screen. Moreover, in order to facilitate swift actions and effective solutions, Idylla system parameters and error logs can be evaluated anytime and anywhere through immediate and remote service support. On the other hand, Idylla Explore provides more insight into test data anywhere, anytime through visualization of PCR curves from Idylla Test Results and direct access to Console Result Reports.

In terms of data protection and privacy, the Idylla Connect network guarantees maximum security as it is built on cutting-edge security technology that allows only Idylla Systems to get access to the network. Idylla Connect mandates a certificate based authentication procedure to make certain that only Biocartis trusted and known systems can connect with the system. Both Idylla Connect and Idylla Explore solutions comply with CLSI’s cyber security standards, AUTO11-A2 (Remote Access to Clinical Laboratory Diagnostic Devices via the Internet), and AUTO-9A (Remote Access to Clinical Laboratory Diagnostic Devices via the Internet), all adopted by the US FDA. The data is transported over a single Transport Layer Security socket between the Biocartis server and the Idylla system, enabling secure end-to-end confidentiality of encrypted data. In doing so, the Idylla Connect data transfer technology thwarts possibilities of tampering with the data.

Added to that, Idylla does not require any information pertaining to patient identity with the test results referencing to anonymous sample IDs. Biocartis suggests users to avoid including patient names and other relevant medical information in the annotations field or the sample ID. To further bolster the data safety, gaining access to the data stored on Idylla Explore requires valid login credentials that are associated with specific data group definitions. The data security architecture makes sure that the test results data are available to only authorized people within the group. The Biocartis server that contains all the transferred test result data is located at the European Biocartis headquarters and is operated by Biocartis staff members with audit functionality.

In terms of data protection and privacy, the Idylla Connect network guarantees maximum security as it is built on cutting-edge security technology that allows only Idylla Systems to get access to the network

Biocartis also allows devising custom-made personalized solutions to meet the unique needs of clients. One can create a network between numerous Idylla User sites and share information and knowledge while gaining direct access to their data to formulate their own solution. The company also empowers users to perform statistical analysis on their obtained data and monitor the data over time. Linking real-time molecular diagnostic test to sample or geo-location data, users can also conduct disease surveillance or diagnostic grids.

Setting a New Benchmark with Idylla

Idylla brings a comprehensive assay menu for oncology comprising assays for KRAS, EGFR, BRAF, NRAS, and MSI. With its state-of-the-art solution and its exceptionally fast turnaround time, Biocartis has made molecular testing affordable and convenient. One of the company’s testimonials reads, “Idylla delivers results within 2 hours instead of 2 days, with minimal hands-on time. This brings huge benefits, as it has the potential to enable faster and improved cancer treatment decisions.” While pathology labs engaging in traditional methods of molecular testing often face difficulties in obtaining samples of sufficient size and quality, with the Idylla system, users require only a minimal amount of sample to conduct tests.

When compared with NGS and other RT-PCR testing methods, the Idylla system eliminates the requirement for large number of consumables, multiple instruments, and increased square footage of laboratory space, ensuring a small footprint and low consumable costs. The single disposable cartridge comes with everything a user needs, which is then loaded onto the Idylla system to prepare for the simultaneous detection of up to 30 molecular targets. Evidently, it’s faster and more intuitive than other molecular testing procedures and revolutionizes the way pathology labs streamline their workflows and conduct tests. Specifically helpful for oncologists, the Idylla system provides fast, reliable, and accurate information for the treatment of lung cancer, colorectal cancer, melanoma, and immune-oncology.

A Team Committed to Enhancing Treatment

Biocartis works closely with its pharma partners to enable accelerated access to treatment with companion diagnostic testing readiness in relevant markets during the launch of their products. Consisting of IVD-experienced project managers, expert scientists, and highly qualified manufacturing, quality, and regulatory personnel, the high-performing Companion Diagnostics (CDx) team supports and helps advance every aspect of the company’s co-development efforts moving from research through commercial and clinical phases. The R&D team at Biocartis consists of laboratory professionals and researchers who hold extensive experience in developing in-vitro diagnostic assays and their critical reagents. The company’s regulatory team too possesses profound knowledge in navigating the regulatory landscape across key global territories. Added to that, engaging its commercial operations team with its partners early in the development phase, Biocartis ensures that their product requirements take into account the market and customer needs from an economic, end-user perspective. Biocartis’ sales, marketing, and market access teams leverage their deep understanding of the oncology testing landscape to support the launch of CDx working closely with its pharma partner.

The Idylla platform and most of Biocartis’ assays are CE marked and approved in many different countries worldwide. Besides, the company’s Idylla Console and Idylla Instrument are listed under class II exempt from FDA 510(k) notification. Fully integrated with the FDA- and ISO-conforming Design Control System, the company’s product development projects undergo a seamless transition from the development stages to manufacturing and commercialization. Biocartis has also established development facilities in Mechelan, Belgium, as well as in New Jersey, US for the optimal support of the company’s global CDx development partnerships. In harmony with applicable regulations, Biocartis is continuously working on the production of effective, safe, and high-quality products and will continue to bring in more innovation in the molecular testing landscape with further enhancements in its ingenious platform.