SOPHiA GENETICS achieves CE-IVD milestone for its Solid Tumor Solution for accurate cancer detection
Lausanne, SWITZERLAND – 11 April 2019: SOPHiA GENETICS, global leader in Data-Driven Medicine, announced today the CE-IVD marking of its Solid Tumor Solution (STS), a new step in the fight against cancer. This standardized molecular diagnostic application precisely detects and characterizes all types of genomic alterations in 42 clinically relevant genes associated with a range of solid tumors such as lung, colorectal, skin and brain cancers.
Cancer is responsible for an estimated 9.6 million deaths in 2018, making it the second leading cause of death globally.“As about 1 in 6 deaths is due to cancer nowadays, it is essential to give patients an early and precise diagnosis. The newly approved CE-IVD Solid Tumor Solution represents a major advancement in the personalization of cancer care. It is designed to maximize diagnostic yield and guide treatment and management decisions,”says Gioia Althoff, Senior Vice President Genomics at SOPHiA GENETICS.
The STS leverages the full power of SOPHiA, the leading technology of choice for streamlined Data-Driven Medicine applications. In oncology, SOPHiA helps clinicians with decision support functionalities based on precision medicine intelligence. It enables simple, central access to relevant therapeutic, prognostic and diagnostic databases to determine the actionability and clinical significance of genomic alterations associated with the cancer type.
The solution has been highly optimized to deliver exceptional accuracy and precision. It can detect single nucleotide variants (SNVs), insertions, deletions (Indels) and gene amplification events. It also identifies microsatellite instability (MSI) status in 6 unique loci associated with colorectal cancer, which is currently recommended for all patients with this disease.
The CE-IVD marking for STS demonstrates the commitment of SOPHiA GENETICS in maintaining a firm focus on delivering robust, dependable and accessible solutions to hospitals all over the world, including some 920 hospitals to date. With the help of SOPHiA’s collective expertise and global network, healthcare professionals can confidently adopt standardized Data-Driven Medicine applications as a part of their routine workflow.
“Personalizing cancer care requires precision in the analysis, clinical interpretation and reporting. The Solid Tumor Solution by SOPHiA GENETICS is a quality-approved solution that helped us streamline the genomic testing workflow and get clinical-grade performance.With the STS, our lab has access to a comprehensive solution that accurately detects clinically relevant genomic alterations associated with solid tumors, accelerating the clinicians’ ability to diagnose patients and deliver the best treatment options,” comments Dr. José Antonio López-Guerrero, Head of Molecular Biology Laboratory at the Instituto Valenciano de Oncología (IVO) – Valencia, Spain.