SOPHiA gets CE mark for STS tumour detection device
SOPHiA GENETICS’ Solid Tumor Solution (STS) has been granted a Conformité Européene in-vitro diagnostic (CE-IVD) mark.
This molecular diagnostic device is designed to detect solid tumours. It is based on the company’s artificial intelligence (AI) technology, which uses statistical inference, pattern recognition and machine learning to analyse genomics and radiomics data.
STS identifies and characterises genomic alterations in 42 clinically relevant genes related to a variety of solid tumours, including lung, colorectal, skin and brain cancers.
The company aims to provide clinicians with access to therapeutic, prognostic and diagnostic databases that would enable decisions on genomic alterations related to a specific type of cancer.
STS identifies single nucleotide variants (SNV), insertions, deletions (Indels) and gene amplifications, as well as microsatellite instability (MSI) status in six locations associated with colorectal cancer.
SOPHiA GENETICS genomics senior vice-president Gioia Althoff said: “As about one in six deaths is due to cancer nowadays, it is essential to give patients an early and precise diagnosis.
“The newly approved CE-IVD STS represents a major advancement in the personalisation of cancer care. It is designed to maximise diagnostic yield and guide treatment and management decisions.”
The company noted that cancer resulted in an estimated 9.6 million deaths last year, becoming the second primary cause of death worldwide.
In February last year, SOPHiA GENETICS secured a CE-IVD mark for its Myeloid Solution, a capture-based molecular diagnostic clinical application intended for detecting haematological disorders.
Myeloid Solution leverages AI to analyse circulating tumour DNA (ctDNA) in liquid samples such as blood, urine and cerebral spinal fluid.