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News items for the in vitro diagnostic industry for the week of Oct. 19, 2020.
The firm said that its core business, excluding COVID-19 clinical testing revenues, returned to positive organic growth in the quarter.
DNA Genotek's devices are used with SARS-CoV-2 tests from Clinical Reference Laboratory and P23 Labs, while Clinical Enterprises' kit is offered by Eurofins.
The RT-PCR-based test may only be performed by Framingham, Massachusetts-based BHD, which is a subsidiary of Eurofins Scientific.
The company said its ELISA assay uses the SARS-CoV-2 nucleoprotein as an antigen for the early detection of antibodies against SARS-CoV-2.
The multiplex RT-PCR test simultaneously detects two target sequences inside the SARS-CoV-2 N gene, providing results in about two hours.
The ELISA-based tests are designed to qualitatively detect three virus-associated antibodies in serum and are being launched immediately.
The assay is a real-time RT-PCR test designed for the qualitative detection of specific sequences of the SARS-CoV-2 N gene in respiratory specimens.
The RT-qPCR test was made available last week after validation in accordance with the US Food and Drug Administration's Emergency Use Authorization guidance.
Eurofins LifeCodexx will commercialize Osteolabs' osteoporosis test in Germany, while BioGen Medical will do the same in Turkey.