Sophia Genetics Gains CE-IVD Marking for Solid Tumor Solution

Sophia Genetics Gains CE-IVD Marking for Solid Tumor Solution
Credit: iStock/vitanovski

Sophia Genetics has obtained the CE-IVD marking for its Solid Tumor Solution (STS), a molecular diagnostic application designed to precisely detect and characterize all types of genomic alterations in 42 clinically relevant genes associated with a range of solid tumors.

Those solid tumors include lung, colorectal, skin and brain cancers.

According to Sophia Genetics, the STS panel can detect single nucleotide variants (SNVs), insertions, deletions (Indels) and gene amplification events. It can also identify microsatellite instability (MSI) status in 6 unique loci associated with colorectal cancer.

STS bundles a capture-based target enrichment kit and is designed to run on the company’s SOPHiA AI clinical genomics platform, designed to assist healthcare professionals in diagnosing and treating patients—with full access to the company’s SOPHiA DDM or “data-driven medicine” clinical research platform for experts performing genomic testing, designed to enable users to explore, interpret and report genomic alterations.

Sophia Genetics said the CE-IVD marking for STS showed the company’s commitment to delivering robust, dependable and accessible solutions to hospitals worldwide. Some 920 hospitals to date have adopted Sophia’s technology.

“The newly approved CE-IVD Solid Tumor Solution represents a major advancement in the personalization of cancer care,” Gioia Althoff, Senior Vice President Genomics at Sophia Genetics, said in a statement. “It is designed to maximize diagnostic yield and guide treatment and management decisions.”

José Antonio López-Guerrero PhD, Head of the Molecular Biology Laboratory at the Instituto Valenciano de Oncología (IVO) in Valencia, Spain, stated that STS has enabled his lab to streamline its genomic testing workflow and obtain 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,” Lopez-Guererro added.

In January, Sophia nearly doubled its total amount of capital raised by closing a $77 million investment round, with proceeds intended for expanding the global community of hospitals using its technology.