Sophia Genetics’ leukaemia detection solution receives certification

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06.02.2018
Blutplasma

SOPHiA Genetics announces CE-IVD marking of its genomic test for leukemia detection. The capture-based myeloid Solution is the best-in-class molecular diagnostic application which empowers clinicians to more precisely diagnose haematological disorders.

As the world’s first capture-based myeloid clinical, the standardized molecular diagnostic application represents a breakthrough in diagnostics for haematological diseases. This includes diseases such as leukemia, which account for 2.5% of all cancers worldwide, and 30% of cancers in children and young adults1. This test comprehensively covers genes associated with haematological disorders and provides clinicians with a complete solution which rapidly and precisely analyses their patients’ DNA.

Sophia’s CE-IVD marked myeloid solution guarantees unmatched performance in the analytical detection of genomic mutations responsible for myeloid and lymphoid leukemia. It does this by providing high on-target reads percentage and coverage uniformity, even in GC-rich regions. Common technical limitations related to the analysis of key biomarkers such as CEBPA, FLT3 and CALR are now overcome with this standardized solution.

The solution also represents a major advancement in the personalization of cancer care. It will facilitate access for patients around the world to a comprehensive diagnostic solution that will identify approved treatment options based on the molecular footprint of each individual’s cancer. This will aid the pharmaceutical industry to optimize biomarker-driven drug development and drug access to the right patients.

Though death rates associated with hematological disorders have decreased significantly in recent years, the number of new cases is steadily increasing. SOPHiA Genetics’s CE-IVD solution alleviates the time and complexity burden of traditional diagnostic technologies with a standardized and easy to adopt solution which empowers clinicians to more precisely diagnose patients with hematological disorders.

(press release)

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