Partnership to Promote Next-Generation Diagnostic Test for CF

Sophia Genetics and Devyser announced a partnership to simplify the adoption of next-generation DNA sequencing (NGS) for routine diagnostic laboratories. According to the terms of the agreement, Sophia Genetics will use its advanced analytical platform, Sophia DDM, to support Devyser’s NGS diagnostic kits for cystic fibrosis (Devyser CFTR) and hereditary breast cancer (Devyser BRCA).

Cystic fibrosis (CF) is caused by mutations in the gene CFTR (cystic fibrosis transmembrane conductance regulator). Individuals who develop CF have two mutated copies of the CFTR gene, one from each parent. These mutations can be detected through genetic diagnostic tests.

“We are very pleased to broaden the choice of NGS kits supported by Sophia DDM,” Jurgi Camblong, Sophia Genetics’ founder and chief executive officer, said in a press release. “Our fast-growing clinical genomics community will be able to leverage Devyser’s reliable and easy-to-use products to obtain clinical grade results on Sophia DDM. This partnership continues to help laboratories unlock the power of NGS with record-low turnaround time, improving both diagnostics and treatment options for patients.”

Sophia Genetics and Devyser’s joint venture, effective immediately, aims to help routine diagnostic laboratories transition to NGS and, in doing so, obtain improved throughput, reduced hands-on time, and verifiable results, according to the release.

“We are very excited to offer NGS technology that has the capacity to revolutionize genetic testing,” said Ulf Klangby, co-founder and chief executive officer of Devyser. “This solution will relieve laboratories from the burden of labor-intensive and complex workflows so that they can really focus on diagnostics. Our partnership will help continue to reduce the diagnostic turnaround time from days to hours, enabling laboratories to significantly improve their efficiency and cut costs.”

Devyser is a specialty company developing diagnostic kits for complex DNA testing in the fields of oncology, reproductive health and hereditary diseases. Its products are used to guide targeted cancer therapies, in rapid prenatal diagnostics, and in a wide array of genetic tests.

Sophia Genetics, which specializes in data-driven medicine, has both  ISO 13485 (Medical Devices Quality Management) and ISO 27001 (Information Security Management) certifications.

The kits will be available through Devyser’s distribution network and to the over 170 member hospitals of the Sophia DDM clinical genomics community.