NEW YORK – Chinese cancer diagnostics firm SeekIn said Monday that it has received the CE mark for its PanCanSeek Cancer Mutation Detection Kit and now intends to market the test in the European Union and other regions that recognize the designation.
PanCanSeek uses high-depth whole-genome sequencing and is intended to support molecular typing, prognosis stratification, treatment guidance, and drug efficacy prediction for patients with hematologic cancers.
The test requires a 2 ml bone marrow sample and utilizes 50X sequencing to detect a variety of DNA alterations including single nucleotide variants, small insertions and deletions, copy number alteration, and structural variants.
Based in Shenzhen, China, SeekIn has CE-marked several other assays this year, including tests for cancer recurrence and treatment monitoring, molecular karyotyping, and multi-cancer early detection.