At the opening ceremony for R&D, training and production buildings at Roche Penzberg, the Pharma giant said that Foundation Medicine (FMI) will establish a digital oncology service at the site offering oncologists across Europe decision support in personalised medicine.
The new buildings, an overall investment of €600m over three years at the site, comprise expansions of Roche’s biomanufacturing facilities (a €330m investment), a production plant for immunodiagnostics (€55m) as well as a lab, office and training facility (€119m) and a new power plant (€65m) and expanded wastewater system (€26m). However, in addition to being Europe’s largest production site, Penzberg will expand its offerings as Roche's Center of Excellence for Personalised Medicine by genome-wide tumour profiling and therapy decision support through FMI's proprietary digital oncology platform, starting operations in Q3/2017.
Foundation Medicine (FMI), in which Roche acquired a majority stake two years ago, will roll out a service across Europe, which enables oncologists to choose the best individual cancer treatment based on a patient’s unique tumour mutation profile. “In a highly standardised process, Roche will determine cancer driving mutations by next-generation sequencing of a patient’s tumour biopsy and compare the mutation profile with 125,000 anonymised tumour profiles currently stored in FMI’s proprietary tumour profile database,” Hagen Pfundner, CEO Roche Pharma AG, Germany, told European Biotechnology. The information is linked to self-learning algorithms that analyse cancer drivers, affected pathways, results from ongoing clinical trials, treatment guidelines etc. and drugs that have helped patients with comparable genomic context delivering decision support for oncologists. The ultimate goal in a later step is to add anonymised treatment outcomes and medical data to the population database with the aim to provide a digital tumour board. According to Pfundner, that service will provide oncologists with data they cannot generate in the clinic providing the opportunity for a more personalised cancer treatment. Oncologists that apply for usage of not yet approved cancer treatments are expected to have better prospects in approval for specific use at payors when they can provide evidence that their therapy choice is based on large scale comparison of treatment options.
In April, Germany decided to reimburse genomic sequencing. The perspective for Roche is to roll out the service across Europe, as countries such as Italy, France, or Lithuania are on the brink to take similar reimbursement decisions.
According to Dr. Ursula Redeker, Spokesperson of the Executive Board, Roche Diagnostics GmbH, Roche is interested to search anonymised population data to get information on tumor parameters that match to specific treatments. “Not the data per se are the value but its interpretation by the intelligent algorithm,” she said.
Germany currently is adapting its strict data protection rules to the EU’s General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679) which allows researchers to ask for broad informed consent as current rules are perceived as obstacle to digital medicine applications.