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Cepheid said that the 4-in-1 test runs on any of almost 30,000 GeneXpert Systems, which provide results in approximately 36 minutes.
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 firms previously received CE mark for a COVID-19 test on the BD Max system in March.
The new guidance allows developers to use other transport media and sample types without first obtaining 510(k) clearance.
The RT-PCR-based test, which runs on Becton Dickinson's BD Max system, simultaneously detects SARS-CoV-2, influenza A and B, and respiratory syncytial virus.
The test runs on multiple GeneXpert systems and tests nasopharyngeal and nasal swabs or nasal wash/aspirate specimens.
The assay should have a CE-IVD mark by November and will serve the Finnish molecular diagnostics firm's growing European client base.
In 2018 Qiagen purchased a 19.9 percent stake in Ann Arbor, Michigan-based NeuMoDx along with the right to acquire the remaining shares.
Overall, GenMark's ePlex Respiratory Pathogen Panel 2 provides results for more than 20 viruses and bacteria, including SARS-CoV-2, flu A and B, RSV, and rhinovirus.
The loan will help fund Scope's development of its PCR One point-of-care molecular diagnostic instrument and related respiratory virus panel.