NEW YORK – Swedish genetic test developer Devyser announced Wednesday it has received CE marking for its next-generation sequencing-based hereditary breast and ovarian cancer assay.
The targeted sequencing test analyzes 12 genes and uses a proprietary amplification-based library preparation.
"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," Devyser CEO and Cofounder Ulf Klangby said in a statement. "With hands-on time kept to a minimum, the lab can process large volumes quickly and deliver the critical results without any further delays." He added that the kit could help clinics work through a backlog of diagnostic testing created by the COVID-19 pandemic.
Devyser also offers a CE-marked BRCA1 and BRCA2 test kit, which can be paired with the 12 gene hereditary cancer panel.