Sophia Genetics has received a CE-IVD mark for its molecular diagnostics test, which will improve the detection of leukemia.

Swiss company Sophia Genetics is a leader in the field of data-driven medicine, with its artificial intelligence (AI) technology already been used to analyze the next-generation sequencing data of over 160,000 patients’ around the world. Today, the company has received a CE-IVD mark for its molecular diagnostics tool, meaning it can be traded within the European single market. The technology reads the genome more precisely to improve the diagnosis of leukemia and boost the personalization of cancer care.

By receiving a CE mark, the company now has permission to trade its product within the European single market as it has shown no adverse effects on human health or the environment. The CE-IVD mark relates specifically to in vitro diagnostic devices that are used to examine blood or tissue samples.

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Sophia Genetics’ test called Myeloid Solution allows the detection of mutations that cause blood cancers like leukemia. This is possible due to the technology very carefully reading the genome, even regions rich in GC base pairs, which can cause problems. This means that key biomarkers of blood cancers like mutations to the CEBPAFLT3, and CALR genes can now be detected.

The company’s AI data analysis technology is combined with liquid biopsies, which are tipped to become the ‘holy grail’ of early cancer detection. British biotech ANGLE leads the way in this field with its Parsortix system offering a full ‘sample to answer’. The company recently claimed that the use of its product could save healthcare providers $5000 per prostate cancer patient.

Sophia Genetics raised$30M (€25M) Series D in September to grow and improve its AI genetic diagnostics platform. Sophia’s CEO Jurgi Camblong commented at the time: “We support over 350 hospitals in 53 countries… By 2020, with the network, members, and data we have, we will move into an era of real-time epidemiology.

The use of AI in diagnostics is a big trend in biotech at the moment due to the power of the technology to quickly analyze test results and provide an accurate diagnosis. In addition, with each use of the system, the algorithm that supports the AI’s analysis becomes smarter.

However, limitations of AI-based technology may be high costs, reducing the ease of access for everyone. STAT-Dx was acquired for up to €153M by Qiagen, which hopes to develop a diagnostic tool for respiratory and gastrointestinal infections, and cancers. The low manufacturing costs of the biotech’s devices make it a highly cost-effective approach.

Although the development of AI-driven diagnostics is very exciting and could benefit many of us in the developed world, it is nice to see that technology is also being produced that will be accessible to a greater proportion of the world’s population.


Media via 279photo Studio / shutterstock; Sophia Genetics

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