The IdyllaTM solution is a revolutionary, fully-automated, real-time PCR based molecular testing system designed to offer results in a minimum amount of time. It makes molecular testing fast, convenient and suitable for any lab. A modular system ready to accommodate your lab’s throughput even as it changes over the years.
All consumables required to perform sample preparation and RT-PCR amplification and detection are provided in a single cartridge that is loaded into the IdyllaTM system. Handling time is less than two minutes per sample and the liquid-tight, disposable cartridges greatly reduce risk of contamination.
MORE INSIGHT INTO YOUR DATA. ANYWHERE. ANYTIME
- Visualization of PCR curves from IdyllaTM Test Results
- Cq Values per target
- Direct access to Console Result Reports
ADVANCED SERVICES TO ENSURE CONTINUITY IN YOUR LABORATORY WORKFLOW
- Automatic software updates
- Immediate and remote service and support
We at Biocartis work closely together with our pharma partners to facilitate accelerated access to treatment by ensuring companion diagnostic testing readiness in the relevant markets at time of launch. Our dedicated, experienced Companian Diagnostics (CDx) team includes proven, IVD-experienced project managers, highly qualified scientists, manufacturing, quality and regulatory personnel as well as an experienced commercial team to support and accelerate all aspects of our co-development efforts moving from research through clinical & commercial phases.
The Biocartis Research & Development (R&D) team of researchers and laboratory professionals has extensive experience in developing in-vitro diagnostic assays and their critical reagents. Product development projects are fully integrated with our FDA- and ISO-conforming Design Control system for seamless transition from development stages to manufacturing and commercialization. For optimal support of our global CDx development partnerships we have development facilities in Mechelen, Belgium, as well as New Jersey, US.
We are continuously working on the production of safe, effective and high-quality products which are in harmony with applicable regulations.
- Our Quality Management System (QMS) is compliant with ISO 13485:2016, 21CFR820 and other international regulations to enable worldwide filing and marketing of the Biocartis platform and associated applications.
- Biocartis QMS is designed to the highest standards to support PMA filings in US.
- Biocartis QMS is ISO 13485:2016 and MDSAP certified for Canada, Australia, Brazil and US by TUV Rheinland.
Our regulatory team has significant experience in navigating the regulatory landscape in key global territories. The IdyllaTM platform as well as most of our assays are CE-marked and approved in numerous countries worldwide. In addition, Biocartis’ IdyllaTM Instrument and IdyllaTM Console are listed as class II exempt from FDA 510(k) notification with FDA -cleared or -approved assays.1
We engage our commercial operations team with our partners early in the development phase to ensure that product design requirements reflect customer and market needs from an analytic performance, end-user and economic perspective. Our sales, marketing and market access teams have a deep understanding of the oncology testing landscape in the key global territories and will support the launch of the CDx in close alignment with our pharma partner by
- developing a global launch strategy for the companion diagnostic
- developing and implementing market access and reimbursement strategies
- setting up KOL programs to drive market awareness and readiness for the diagnostic test
- establishing medical education programs
- organizing trainings for lab staff