An Interview with SOPHiA GENETICS: STS and the CE-IVD Designation
We recently covered the news that SOPHiA GENETICS’ Solid Tumor Solution (STS) application was granted a CE-IVD designation, a regulatory stamp that a product has satisfied the EU’s in vitro diagnostic device requirements and is ready to be used for in vitro diagnostic examination. But what does this designation mean for hospitals? We spoke to Gioia Althoff, SOPHiA’s Senior Vice President, Genomics Business Area, about the STS application and where SOPHiA is going from here.
FLG: What is the STS Application?
GA: Our Solid Tumor Solution (STS) is a clinical genomic solution that identifies and characterises all types of alteration, covering 42 different genes across several types of cancer, including lung, colon, skin and brain. This application combines our AI technology SOPHiA with a smart kit design for the best possible analytical performance to support clinicians in diagnosing patients with solid tumours.
FLG: What Happens After the STS Application Has Detected and Characterised Alterations? What Can Be Done with This Information?
GA: After the solution has accurately detected these genetic alterations, platform users will be able to visualise and interpret the data in an oncology-centric way. Our platform enables them to filter the results in order to better make informed decisions.
FLG: You Just Received a CE-IVD Mark for the STS. What Does This Marking Mean for SOPHiA GENETICS and to the User?
GA: It shows our dedication to bringing standardised and best-in-class genomic applications in routine diagnostics. It’s a solution that can be easily taken up because it understands the constraints of the clinical world while providing direct benefits to both hospitals and patients.
FLG: How Many Oncology Solutions do you Currently Have in Your Portfolio, and How is the Current Uptake from Hospitals?
GA: From inception, which was around 2014/15, when we started bringing solutions to the market, we had a strong adoption of hereditary disorders applications in particular. We then also committed to provide the same level of excellence to oncology applications for the fight against cancer. It recently led to the CE-IVD marking of the Solid Tumor Solution by SOPHiA GENETICS. Out of 180 clinical genomic applications in total, we have approximately 80 dedicated to solid and liquid tumours, which is around 45%.
FLG: What are SOPHiA GENETICS’ Plans in Oncology? Where are you Hoping to Grow and Which New Solutions are You Currently Working on?
GA: There is a definite a need in oncology to constantly compile and add more information, so genetic profiling of tumours is essential, but not sufficient to take actionable decisions. For example, we have further enhanced SOPHiA capabilities by adding radiomics analysis, aiming to predict the evolution of the tumour and monitor treatment efficacy through images (CT-scan, MRI, etcetera). The combination of genomic and radiomic information is the next step in cancer management to establish personalized and efficient treatment strategies.
In the near future, SOPHiA Platform will gather and analyse information from different sources of data (genomics, radiomics, clinical data, etcetera), to provide the best information for decision-making. Ultimately, SOPHiA will enable hospitals to enter into the era of real-time epidemiology, where we will be able to cluster patient’s cancer cases in virtual cohorts, and predict that a patient’s cancer looks like one of 10,000 other patients, and the most effective treatment has proven to be X or Y.
FLG: You Announced Your US Expansion Last Year. What are You Doing to Build Your US Presence, and will the EU still be a Focus for SOPHiA GENETICS in the Future?
GA: We’re expanding the team dramatically in the US in order to face the growing demand in the region. In parallel, we continue to develop SOPHiA by adding analytical capabilities and combining different sources of medical data, in oncology for instance with the combination of genomics and radiomics.
The EU will always be a focus for us: we already have a large network there which we’ll continue to support and grow. This is why we are talking about the democratisation of data-driven medicine worldwide. We encourage every institution to adopt such tech applications, not only for the direct benefit for their patients but also because it allows for a more sustainable global healthcare system where the information used to help patients today will help those of tomorrow.