Sophia Genetics S.A.. (2/6/18). "Press Release: Sophia Genetics Announces CE-IVD Marking of Its Genomic Test for Leukemia Detection". Lausanne.

	Region	EU (European Union)
	Organisation	Sophia Genetics S.A.
	Group	Sophia Genetics (Group)
	Product	clinical genomic test (nucleic acid diagnostics)
	Product 2	cancer test, molecular diagnostics

The Myeloid Solution by SOPHiA GENETICS is the best-in-class molecular diagnostic application which empowers clinicians to more precisely diagnose hematological disorders

SOPHiA GENETICS, global leader in Data-Driven Medicine, unveiled today the world’s first capture-based myeloid clinical solution to receive the CE-IVD mark. The standardized molecular diagnostic application represents a breakthrough in diagnostics for hematological diseases. This includes diseases such as leukemia, which account for 2.5% of all cancers worldwide, and 30% of cancers in children and young adults[1]. This test comprehensively covers genes associated with hematological disorders and provides clinicians with a complete solution which rapidly and precisely analyzes their patients’ DNA.

The CE-IVD marked Myeloid Solution by SOPHiA GENETICS guarantees unmatched performance in the analytical detection of genomic mutations responsible for myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN) and 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 newly approved CE-IVD Myeloid Solution by SOPHiA GENETICS 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’ CE-IVD certified Myeloid 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.

[1] http://www.euro.who.int/__data/assets/pdf_file/0005/97016/4.1.-Incidence-of-childhood-leukaemia-EDITED_layouted.pdf

Record changed: 2023-06-05