Idylla™ : a lab-in-a-box

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Janssen and Biocartis are collaborating in order to bring diagnostic  testing closer to the patients. To learn more about the future objectives of the Janssen – Biocartis partnership we are talking with Daap Kooij, the Global Business Leader at Janssen Diagnostics, a Medical Biologist who also holds an MBA.

Based on recent scientific findings, doctors are beginning to move away from the one-drug-fits-all approach to prescribe medicine. Instead doctors are using personalized medicine, which uses the genetic profile of the patient and/or the pathogen, to diagnose and help determine the optimal treatment for the patient. Personalized medicine uses molecular diagnostics, makes treatments more effective and decreases healthcare costs. In order to be able to provide a personalized approach to treating patients, patient samples must be analyzed. Currently most hospitals send patient samples to a centralized laboratory, this is both time- and labor-consuming. Moreover, only highly trained personnel are qualified to analyze these samples. It can take up to several weeks before the results are available and treatment can start. Idylla™, developed and produced by Biocartis, is a miniaturized, fully automated molecular diagnostics platform that is about to create a new standard in patient sample processing.

What is Idylla™?

Idylla™ is a molecular diagnostics system that integrates all of the technical procedures into a one step, easy-to-use system. It can be used for any human clinical sample, including blood and biopsies, even if they are paraffin embedded. DNA or RNA present in any clinical sample can now be processed directly and analyzed with multiplexed real-time PCR amplification and detection technology on Idylla™. Biocartis launched the platform in September 2014 along with the BRAF mutation test for melanoma. A second test, the KRAS mutation test for colorectal cancer was launched in June 2015. Biocartis is in the process of developing additional assays for different types of cancer. The platform also has the potential to be used in the diagnosis of indications other than cancer, such as infectious diseases. Both Biocartis and its strategic partner, Janssen Diagnostics, are developing assays for the diagnosis of infectious diseases to be used with the Idylla™ system.

Janssen Diagnostics – a partner from day 1

Janssen Diagnostics, established in 2012 as a part of Janssen Pharmaceutica R&D, is focused on personalized medicine. Could you explain your business model?
Daap Kooij: “We are orchestrating access to diagnostic tools that are not yet available on the market. We look at diagnostics from a global perspective, so we team up with other players in this field in order to gain access to foreign markets. Collaborations with our partners also help us to identify the areas where we can add the most value to the healthcare system and generate tools that will directly benefit patients.”

Partnership is a key aspect in regards to success in all diagnostic domains and to cover the marketplace worldwide.

“In order to achieve these goals we are working together with Biocartis, but we have also formed partnerships with other companies such as with Philips to develop diagnostic applications in the field of neuroscience (schizophrenia), with Irish Almac to set up services in support of our compounds, with Danish Dako and many others.

The partnership with Biocartis was established to bring diagnostic tools closer to the patient. What is special about this collaboration?
Daap Kooij: “Our partnership with Biocartis reflects our vision of what the future diagnostics market will look like. Today, most of the testing is processed in centralized labs, around which the healthcare system is organized. This organizational structure has arisen from the available technologies.”

There are many cases in which time is essential. Life saving decisions need to be made quickly; therefore testing should be easily accessible, fast and close to the patients.

“These unmet needs are what particularly attracted us to the Biocartis’ Idylla™ platform. After obtaining necessary regulatory approval, Idylla™ could be run anywhere. This is how we see the future of the diagnostic testing evolving; it will become an integral part of the healthcare system, providing a rapid, easily accessible solution.”

What additional tests are being developed for Idylla™?
Daap Kooij: “Strategically we are looking to develop companion diagnostics for drugs developed by Janssen Pharmaceuticals that would have optimal performance when used in combination with personalized information from patients. Companion diagnostics also provide additional information on efficacy and safety. We are currently partnered with Biocartis in the development of an Ebola diagnostic assay that is expected to be available in September. We have also independently developed the Idylla™ INF/RSV respiratory viral panel assay, which is for the diagnosis of Influenza and Respiratory Syncytial Virus infections. It will be launched in the third quarter of this year.”

Idylla™, with its ability to be used in multiple disease indications and simple design and use, has great potential to revolutionize healthcare.
Daap Kooij: “Taking time-critical tests out of the centralized labs, while ensuring the highest possible sensitivity, specificity, and speed, and bringing them closer to the patients is our ultimate goal. This domain is very much underserved, and Idylla™ is one of the options that allow us to address this.”