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Genetron Health Receives CE Mark for Lung Cancer Sequencing Assay

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.

The Scan

Close Panel Vote on Califf Nomination

The New York Times reports there was a close committee vote to advance the nomination of Robert Califf to lead the US Food and Drug Administration to the full Senate.

Task Force Reports on Scientific Integrity

Nature News writes that that a new task force report recommends that the US establish a cross-agency scientific integrity council.

Across the Hall

Genetic testing, closed-circuit cameras, and more show how a traveler, without any contact, infected others at a New Zealand quarantine facility, CNN reports.

Science Paper Examines Influence of Chromatin Modifications on Obsessive-Compulsive Disorder

In Science this week: genes regulating chromatin modification may contribute to OCD risk.