FDA approves pan-tumour genomic profiling assay

FMI, in which Roche is majority shareholder since 2015, said that its comprehensive companion diagnostic assay is designed to support physicians in clinical decision-making. Two months ago, the companies, which aim to bring services based on FMI’s database with 140,000 tumour profiles to oncologists across the world, launched a digital tumour board solution to support decision making in oncology based on genetic surrogate markers. The ultimate future goal of the companies, however, is to integrate diagnostic tumour profiles with clinical and imaging data to generate a comprensive data source to allow personalised oncology care.

According to Roche, FDA approval of FMI’s assay, means the service can be used as a companion diagnostic for selection of 17 approved cancer therapies when people have been diagnosed with solid tumours. FoundationOne CDx allows to assess genomic alterations in 324 genes known to drive cancer growth; identify patients with advanced cancer who are likely to respond to targeted therapies; and report genomic signatures, including microsatellite instability (MSI) and tumour mutational burden (TMB), and report genomic alterations in other genes for use by physicians for patient management.

Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development said: “Our belief is that profiling will increasingly become routine in clinical practice, so we have worked closely with Foundation Medicine to develop an extensive clinically and analytically validated platform that can support both existing and future companion diagnostic needs.”

FMI offers a unique tumour sequencing service that is already well established in the US. It has developed sophisticated algorithms that allow analysis of a patient’s DNA to be used to identify and match individual tumour mutation patterns to suitable treatments. In this way, tumour profiling also allows better patient stratification for clinical trials and when combined with liquid biopsy, real-time therapy monitoring.

Since 2015, Roche has been commercialising Foundation Medicine’s portfolio of services in countries outside the US, with more than 20 countries on three continents already having launched FoundationOne. Most recently FMI opened its first lab in Europe at Roche’s Penzberg site, near Munich. The company intends also to open a lab in Switzerland. 

Uptake in Germany, however, has been hampered by concerns of oncologists and pathologists about R&D limitations through the FMI’s proprietary database model, which has seemingly become an imminent part of the cancer genome dataminer business model. It’s even good if providers apply their learning algorithms to genomic data,” said Christoph von Kalle, Director of the National Centre of Tumor Diseases in Heidel­berg. “However, if the assays or the sequencing were reimbursed by payors, the results must not be locked up in proprietary data­bases.“ According to Albrecht Stenzinger, Head of the Center of Molecular Pathology in Heidelberg, “it’s not a good idea to lock away NGS results of tumour biopsies in proprietary databases, as Myriad Genetics does for BRCA diagnosis.” It’s still subject of negotiations how to resolve the concerns.