CE mark

The xT platform integrates structured clinical patient data with results from a 648-gene DNA panel and whole-transcriptome RNA sequencing.

Cepheid said that the 4-in-1 test runs on any of almost 30,000 GeneXpert Systems, which provide results in approximately 36 minutes.

The kit is designed for use with samples stored in the company's CE-marked DNA/RNA Shield sample collection and preservation devices.

The firm CE marked its RespiFinder 2Smart kit for SARS-CoV-2 and MERS-CoV testing, as well as the RealAccurate Quadriplex Flu/COVID-19 PCR kit.

The firm said the assay is an enhanced version of a test it made available this summer that measures the amount of neutralizing antibodies to SARS-CoV-2.

One of the tests is customized for use on Bioneer's automated ExiStation instrument, while the other is compatible with various standard PCR systems.

The company said that it has received CE marks for two additional SARS-CoV-2 tests, including one that detects the virus and influenza A/B.

Hologic designed its scalable AI-based cytology platform to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.

Qiagen received CE IVD marking for its NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test and for a saliva collection kit for its single-plex NeuMoDx SARS-CoV-2 assay.

The new assay has a 24-minute turnaround time, uses 50 microliter samples, and offers longer, 40-day calibration stability than the current Vitros TSH assay.