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CE-IVD marking recognises Sophia Genetics Hereditary Cancer Solution unmatched performance, the first of its kind to allow for the diagnosis of hereditary breast, ovarian and digestive cancers
SAN FRANSISCO, USA – 11 January 2016: Sophia Genetics, global leader in Data-Driven Medicine, announced today, from the 35th Annual J.P. Morgan Healthcare Conference, the CE-IVD marking of its Hereditary Cancer Solution. A simple and fast procedure for healthcare professionals engaged in clinical diagnostics, Sophia Genetics Hereditary Cancer Solution helps quickly screen the 27 most relevant genes associated with hereditary cancer. It is the first solution CE-IVD marked that allows for the diagnosis of hereditary breast, ovarian and digestive cancers.
The CE-IVD certification applies to both the kit (IDT’s xGen® Lockdown® Probe target capture technology) and the analytics, which together make up Sophia Genetics’ Hereditary Cancer Solution. This joint certification makes the Hereditary Cancer Solution the only product of its kind to be CE-IVD marked. This powerful mix ensures SOPHiA, Sophia Genetics AI, is fuelled with high quality data to deliver unmatched analytical performance for the detection of genomic mutations responsible for hereditary breast and ovarian cancer, lynch syndrome, intestinal polyposis syndrome and familial adenomatous polyposis.
Early genomic testing can help identify an increased risk of particular types of cancer due to gene variants passed on from parent to child. Sophia Genetics’ CE-IVD marked Hereditary Cancer Solution will thus help clinicians with patient counselling, allowing them to suggest appropriate lifestyle changes, encourage regular cancer screening for early detection, prescribe medicines to reduce disease risk, or recommend risk reducing surgery.
Reacting to this achievement for target capture–based technology, Dr. Joseph Walder, Founder of IDT, said “We are excited that xGen® Lockdown® Probes have contributed to Sophia Genetics Hereditary Cancer Solution being granted a CE-IVD mark. This represents a major step in IDT’s support for the diagnostics community with robust reagents that facilitate early and accurate detection of disease risk through genomic testing, and demonstrates our commitment to driving advances in genetics and medicine.”
Commenting on this joint certification making the Hereditary Cancer Solution the only product of its kind to be CE-IVD marked, Jurgi Camblong, CEO and Co-Founder of Sophia Genetics, concluded: “The CE-IVD marking of our Hereditary Cancer Solution illustrates our continued efforts to ensure the best accuracy in genomic testing, and is another milestone on our journey towards the democratisation of Data-Driven Medicine.”
SOPHiA GENETICS products are for Research Use Only and not for use in diagnostic procedures unless specified otherwise.
SOPHiA DDM™ Dx Hereditary Cancer Solution, SOPHiA DDM™ Dx RNAtarget Oncology Solution and SOPHiA DDM™ Dx Homologous Recombination Deficiency Solution are available as CE-IVD products for In Vitro Diagnostic Use in the European Economic Area (EEA), the United Kingdom and Switzerland. SOPHiA DDM™ Dx Myeloid Solution and SOPHiA DDM™ Dx Solid Tumor Solution are available as CE-IVD products for In Vitro Diagnostic Use in the EEA, the United Kingdom, Switzerland, and Israel. Information about products that may or may not be available in different countries and if applicable, may or may not have received approval or market clearance by a governmental regulatory body for different indications for use. Please contact us at [email protected] to obtain the appropriate product information for your country of residence.
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