NEW YORK – Genetron Health said Tuesday that it has received the CE mark for its eight-gene lung cancer sequencing assay.
The test kit, which has also been approved by China’s National Medical Products Administration, uses a technology called One-Step Seq, which allows for a single-reaction library construction process, minimizing manual operation and reducing the chance of contamination.
The assay covers mutations in EGFR, BRAF, KRAS, HER2, and PIK3CA, translocations of ALK and ROS1, and MET exon 14 skipping, and is compatible with the Genetron S5 sequencing platform.
Genetron CEO Sizhen Wang said in a statement that this platform-assay combination, along with added bioinformatic support, provides a highly automated end-to-end solution for hospitals and clinical laboratories that prefer to run next-gen sequencing testing on their own rather than send samples to an outside lab.
"We believe that this offers a significant operational advantage for our customers outside China," Wang added.