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Genetron, Burning Rock, Others Receive CE Marks for Cancer, COVID-19 Tests

NEW YORK – Genetron Holdings, Burning Rock Biotech, and other firms announced on Wednesday that their tests for cancer detection and the diagnosis of COVID-19 have received CE marking.

Genetron Holdings announced its FusionScan Plus Kit was CE marked. The kit is an integrated DNA and RNA next-generation sequencing-based assay for the simultaneous detection of multiple gene mutations and fusions with lower thresholds. Based on the firm's One-Step Seq Method, FusionScan Plus covers 29 tumor-related mutant genes and 40 fusion genes, Beijing-based Genetron said.

Burning Rock said it has received CE marking for its OverC Multi-Cancer Detection Blood Test, a qualitative next-generation sequencing-based in vitro diagnostic test for detecting DNA methylation markers using cell-free DNA from human peripheral whole blood. The test is for the early detection and localization of multiple cancer types in individuals 40 to 75 years of age, the Shanghai-based company said.

Meanwhile, Stockholm-based Stratipath said its AI-based Stratipath Breast software for the prognostic risk stratification of breast cancers has been CE-IVD marked. The software is for the analysis of digital histopathology whole-slide images stained with hematoxylin and eosin. According to the company, Stratipath Breast enables faster turnaround time than traditional molecular tests and provides new information at the point of diagnosis while reducing costs.

Novacyt said its PathFlow COVID-19 Rapid Antigen Self-Test was CE marked. The saliva-based test is for the diagnosis of COVID-19 in symptomatic and asymptomatic individuals and provides results in about 15 minutes, the French diagnostics firm said. It added that it has submitted the test for approval under the UK Health Security Agency's Medical Devices Regulations 2021 (or Coronavirus Test Device Approvals) for sale there.

Novacyt also said that its ProMate COVID-19 1G (q16) Real-Time PCR test for use on the firm's q16 instrument has been approved under CTDA.

Lastly, Sydney-based Beroni Group said its COVID-19 Antigen Rapid Test Kit – Colloidal Gold Method has been CE marked. According to Beroni Group CEO Jacky Zhang, the firm is applying for regulatory approval of the test to market it in other markets.