Devyser’s breakthrough NGS product for hereditary breast and ovarian cancer testing now approved for diagnostic use in the EU

Swedish genetic test developer Devyser’s product for hereditary breast and ovarian cancer (HBOC) is now CE labelled and approved for diagnostic use in the EU. The kit is based on Devyser’s patented next-generation sequencing library prep technology and provides targeted sequencing of 12 genes with a recognized connection to the development of breast and ovarian cancers, for a total of 14 genes when combined with Devyser’s BRCA test.

"When Covid-19 testing took precedence over all other types of molecular diagnostics thousands of other patients had to wait for their test results, in many cases significantly delaying diagnosis and treatment".

Says Ulf Klangby, Founding partner and CEO Devyser.

"Laboratories now face a massive testing debt as ordinary testing is resumed. I am proud that Devyser now offers a game-changing solution for hereditary breast and ovarian cancer diagnostics that enables laboratories to deliver results in just 24 hours, faster than any other product on the market. With hands-on time kept to a minimum, the lab can process large volumes quickly and deliver the critical results without any further delays."

I am proud that Devyser now offers a game-changing solution for hereditary breast and ovarian cancer diagnostics that enables laboratories to deliver results in just 24 hours, faster than any other product on the market.

The HBOC NGS kit is part of Devyser’s NGS Oncology suite, complementing the company’s BRCA kit that enables simultaneous screening of mutations in the BRCA1 and BRCA2 genes. Both kits are approved for diagnostic use in the EU and are available worldwide through Devyser’s global network of distributors and direct sales.

Devyser’s HBOC NGS kit is an end-to-end solution including reagent kit and software, designed for use in routine diagnostics. The robust product is easy to implement, maintain and use. It has a user-friendly workflow with just 45 minutes hands-on time and a total laboratory process time of five hours. The complete process from sample to results takes just 24 hours.