Biocartis: ready for commercial boom

While there are many innovative biotech companies in Belgium, few are in a position as enviable as that of Biocartis. Over the past few years Biocartis  set itself apart from the field with the release of its revolutionary diagnostic platform Idylla™ and a more than successful IPO on Euronext Brussels. Since the launch of Idylla™ back in September 2014, the company has been able to fully focus on expanding its menu of available assays. With more and more tests being released, Biocartis is rapidly increasing its reach, and with each available Idylla™ cartridge, it comes closer to becoming an absolute force within the biotech and diagnostics industry.

In 2007, serial biotech entrepreneur Rudi Pauwels founded Biocartis in Lausanne, Switzerland. When looking for suitable regions to accommodate its expansion, Biocartis soon looked to Belgium, and in 2011 the company decided to establish its R&D center and first production unit in Mechelen. Biocartis has been a well-known and respected member of the Belgian biotech community ever since. Read more news on Biocartis

Tools of the trade

The Idylla™ molecular diagnostics platform is the foundation upon which Biocartis is built. Idylla™ is the first diagnostic instrument that integrates all steps from sample preparation to analysis, resulting in a fully automated workflow from sample to result. This shortens the necessary hands-on time to less than two minutes. In total, the tests can be completed in a timeframe between 35 and 150 minutes; comparable analyses with previously existing methods can take days or even weeks. The assays are developed in cartridge form, which can then be run on the Idylla™ platform. Biocartis consciously chose to focus its assay development on the largest and fastest-growing market segments of IVD: infectious diseases and oncology, respectively. As of now, the repertoire of assays includes mutational panels for melanoma, colorectal and lung cancer and an assay that can detect influenza and respiratory syncytial viruses. In the coming years, however, Biocartis will expand its “diagnostic app store” with both solid and liquid biopsy cancer tests when it comes to its oncology test menu, and syndromic panels including a respiratory pathogen panel, a meningitis panel and bloodstream infections (including sepsis) in terms of its infectious disease test menu.

Broadening the scope

“In the fields of oncology and infectious diseases, we can leverage an important asset of Idylla™: its tremendous potential for multiplexing,” says Geert Maertens, Chief Scientific Officer at Biocartis. “We can detect a large range of mutations related to a specific cancer. Our KRAS test for colorectal cancer, for instance, analyses 21 relevant mutations in one assay. While today clinicians only need to know whether or not a mutant is present, many drugs are in development that target specific KRAS mutants. By reporting 21 mutations in detail, we have developed a product that can be routinely used for diagnosis, e.g., in hospital settings, and for drug development in clinical trials. We know that in the near future, this additional, detailed info can possibly be very valuable for patient-specific or ‘personalized’ medicine. This is already the case for BRAF mutations in melanoma, where patient treatment depends on which kind of BRAF mutation is present in the tumor.” “In the market segment of infectious diseases, there is a large demand for syndromic panels. Patients often show general symptoms such as fever, diarrhea or respiratory problems. In these cases, it could be relevant to scan a broad spectrum of possible pathogens in one sample, as quickly as possible. Idylla™ is excellently suited for such use, and here, the speed and multiplex capacity of the system can truly make a difference. An important trend, not only in infectious diseases but in the diagnostics market as a whole, is the move towards a more comprehensive approach. Idylla™ fits perfectly with that notion.”   Read more news on Biocartis Getting rid of the time factor With infectious diseases, it is easy to see why time is an important element: Infections such as meningitis can have serious consequences in the short term. For cancer, however, this is less obvious, as the disease is generally more chronic in nature. Regardless, the speed of Idylla™ has heralded a true transformation for the diagnostic process in cancer. Maertens elaborates: “Two years ago, people told us that time wasn’t important in oncology. It takes a few days before patients can be scanned, the medical board needs to convene to decide on further action, molecular testing takes another two or three weeks. Now that we are able to drastically decrease the time for molecular testing to a couple of hours, the whole process could be sped up.”

We see that Idylla™ has become an enabler: Based on the turnaround time of our tests, certain hospitals try to carry out everything from scans to molecular testing to diagnosis and treatment selection in one single day.

“As such, Idylla™ becomes an essential part of the fast decision-making process. As with many revolutionary technologies, users get accustomed to the fact that it works so tremendously fast. Once they are used to a certain advantage, it’s taken for granted, and users start fitting it into their workspaces or daily lives. Idylla™ simply offers the possibility of rapid and highly accurate analysis, which impacts the entire workflow.”

Beyond the test

There are still a lot of possibilities for Biocartis in infectious diseases and oncology, and the coming years will see the release of many more cartridges in those fields. In the longer term, however, the company wants to expand the applicability of its technology and use it to design next-generation sequencing preparatory panels. A strange transition? Not according to Maertens: “The Idylla™ tests scan samples for mutations that are most frequently related with a certain type of cancer. For most cancer patients, these assays offer a clear answer to what mutation is causing their cancer and what types of targeted therapy might be suitable. Regrettably, a small fraction of patients have tumors in which the most prevalent markers are absent. In these cases, the next logical step is sequencing the entire tumor DNA. With our NGS prep panels, we want to form the bridge between regular testing and full sequencing, which requires complex infrastructure and long preparation time. The idea is to incorporate our NGS prep panels in our regular assays. In that way, if our tests would not provide a conclusive answer, running them will already create the NGS library and make it available for sequencing. This again reduces the time of the entire process from several days to a couple of hours with only one minute of actual work.”

Risk assessment and synergy-searching

Now that Idylla™ is starting to establish itself as a valuable diagnostic system, it’s highly important to expand the existing menu of tests as fast as possible. Luckily for Biocartis, many parties are interested in partnering up for the development of tests relevant to them. For example, pharmaceutical companies could develop specific cancer treatments that fit a certain mutation or cancer. As such, some programs can be accelerated through partnerships. “The platform offers so many possibilities, sometimes we don’t know what to do first. Of course you can’t do everything by yourself, so partnerships are an important aspect of our strategy. Because of all the possible roads we can take with Idylla™, we really need to carefully select the projects to invest our time in. Some pharmaceutical companies propose to co-develop totally new tests, linked to a specific treatment offered by the partner in question. If the developed test is very specific, narrow and only useful in conjunction with the therapy, we take a huge risk: Should the therapy fail in clinical trials, the tests have no further purpose. Making that risk assessment is utterly important. Ideally, we choose to set up partnerships for the development of tests that are already in our pipeline. About a year ago, we announced our commercial and development partnerships with Amgen and Merck, two industry greats. Together, they possess 60% to 70% of the colon cancer market, and both require RAS mutation tests on a routine basis. Thanks to the collaborations with these companies, we can drastically accelerate these programs that were already in our pipeline. Synergies such as these are really what we are looking for in partnerships and collaborations. In general, accessibility to sophisticated molecular testing is a very important need for pharma companies. This is where Idylla™ can create that market access. The choice of whether to develop a product internally or to start a partnership is also highly dependent on the technology behind the assay. If we have already released a similar product, we will opt to develop the new product ourselves instead of going through an entire tech transfer to an external party. If the test is relatively simple and the expertise is with the potential partner, setting up a collaboration is a logical step. In those cases, we can support in the sample prep part of cartridge development and help with general platform support.” Read more news on Biocartis

An even better future

Biocartis just keeps gaining momentum. The number of installed Idylla™ instruments is increasing rapidly, the R&D engine is running at full capacity with 17 ongoing projects and cartridge production is scheduled to receive a significant boost with a second, larger manufacturing line operational by 2017. Biocartis is also awaiting 510(k) approval from the US FDA for Idylla™ and the Idylla™ Respiratory (IFV-RSV) Panel, and is in preparation of its China strategy to be expected in the second year-half, as such paving the way to more growth. With a bright future ahead, Biocartis has many things to look forward to. This article appears in the BioVox White Paper on In Vitro Diagnostics, May 2016. Download the complete work here for free.