Sophia Genetics obtains CE-IVD marking for BRCA1/2 testing solution

Sophia Genetics, the European leader in Data Driven Medicine, has today obtained CE-IVD marking for its solution to detect BRCA1/2 associated genetic variants in live tumours.

Hospitals and laboratories will now benefit from Sophia Genetics’ advanced platform as a companion diagnostic that will allow the better diagnosis of patients using Next Generation Sequencing (NGS) technologies. The decision will also ultimately enable the prescription of new drugs such as poly ADP-ribose polymerase (PARP) inhibitors which rely on genetic diagnosis.

PARP inhibitors exploit tumour DNA repair pathway deficiencies to preferentially kill cancer cells. An example is the recently approved ovarian cancer therapy Lynparza™ (olaparib), which is also currently undergoing clinical trials for use in breast and gastric cancer. The drug is effective only when used with companion diagnostics which identify whether patients have BRCA1/2 associated genetic variants in their tumour samples.

CE-IVD approval for Sophia Genetics’ analytics platform means that it can now be used to harness the power of genetics to identify which patients can benefit from Lynparza™ and other drugs like it. Genetic testing and analytics can also help to inform decisions on the use of chemotherapy in cancer management.

The Swiss national health insurance fund (AOS) recently agreed to reimburse genetic testing of live cancerous tissues – a decision likely to be followed by other European countries looking to offer the benefit to patients already living with chronic conditions. Such developments will lead to the more widespread use of companion diagnostic testing alongside breakthrough therapies to improve patient outcomes.

Commenting on the news from the J.P. Morgan 33rd Annual Healthcare Conference in San Francisco, Jurgi Camblong, CEO and Co-Founder of Sophia Genetics said:

Effective reimbursement for live tissue testing is a big step forwards for improving cancer care in an accessible way. Now, cancer patients with specific genetic mutations can be identified and treated more effectively through the latest personalised therapies.

It is only through the use of cutting edge analytics that doctors can make sense of genetic data in this way. Reimbursement of testing must also mean greater use of analytics to improve and speed up clinical decision making.

Dr Pierre Hutter, CSO and Co-Founder of Sophia Genetics, added:

Identifying BRCA mutations as a risk factor in cancer is not new, but now we have the ability to determine whether people already living with cancer fall into this category and can therefore benefit from personalised treatment options.

Europe is taking a lead on driving access and improved outcomes through reimbursing genetic testing that can inform clinical decision making. Patients living with cancer will benefit from access to targeted therapies through the use of highly accurate and speedy diagnostics.