CE mark

Bio-Techne said pathologists now have access to its fully automated RNAscope technology, providing them with a new tool to evaluate disease biomarkers.

During evaluations of 180 randomized specimens, the Genedrive 96 SARS-CoV-2 Kit achieved 100 percent sensitivity and 98.2 percent specificity, the firm said.

With a €930,000 from Horizon 2020, the firm is conducting additional stories to evaluate other uses for the test, including using new specimen types and patient cohorts.

The RT-PCR test targets the N gene and E gene regions of the SARS-CoV-2 genome in a multiplex format.

The DeepChek-HIV assays are designed for settings running either Sanger sequencing or next-generation sequencing workflows, according to the company.

The company, which launched the technology in September 2019, said in its Q4 earnings release that it received high marks from beta testers.

The cancer test developer will use the funding to commercialize its enrichment-based NGS panels. An IVD test also got CE marked.

The multiplex RT-PCR test simultaneously detects two target sequences inside the SARS-CoV-2 N gene, providing results in about two hours.

PlexBio said it is working with regional distributors to have its IntelliPlex SARS-CoV-2 Detection kit certified in various ASEAN countries.

The rapid automated RT-PCR test detects SARS-CoV-2 from nasopharyngeal, oropharyngeal, or nasal swab specimens and runs on NeuMoDx's Molecular Systems.