SOPHiA GENETICS gets CE-Mark for genomic leukaemia detection test

7 February 2018 (Last Updated February 7th, 2018 12:10)

SOPHiA GENETICS has obtained CE-IVD mark for its capture-based molecular diagnostic clinical application called Myeloid Solution designed to accurately detect a variety of haematological disorders such as leukaemia.

SOPHiA GENETICS gets CE-Mark for genomic leukaemia detection test
SOPHiA GENETICS’ new genomic test diagnoses haematological disorders. Credit: Prachatai / Flickr.

SOPHiA GENETICS has obtained CE-IVD mark for its capture-based molecular diagnostic clinical application called Myeloid Solution designed to accurately detect a variety of haematological disorders such as leukaemia.

The new test examines genes related to haematological diseases, and provides a quick and precise solution to assess the DNA of a patient.

According to the firm, the test ensures quality performance for the analytical detection of genomic mutations related to myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), and leukaemia.

The diagnostic solution is also said to address common technical challenges that are associated with the analysis of key biomarkers such as CEBPA, FLT3, and CALR.

Based on the molecular footprint of an individual’s cancer, the Myeloid Solution is reported to be capable of identifying suitable approved treatment options.

“Its standardised and easy solution will lessen the time and complexity burden for clinicians.”

SOPHiA GENETICS expects that this capability of the test will aid in personalisation of care, biomarker-driven drug development, and improve drug access to cancer patients.

As the number of new cases with haematological disorders is increasing, the firm anticipates that its standardised and easy solution will lessen the time and complexity burden for clinicians to more precisely diagnose haematological conditions.

In an effort to assist clinicians in better diagnosis, treatment and monitoring of cancer, the firm introduced an artificial intelligence (AI) powered solution for liquid biopsies in June last year.

The new application uses AI to analyse circulating tumour DNA (ctDNA) present in patient’s liquid samples such as blood, urine, and cerebral spinal fluid.