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Promega

High-throughput sample prep is becoming critical to COVID-19 testing scale-up, but some labs are experiencing shortages at this stage in the testing workflow.

The company expects to garner clearance for its platform in the US first for Lynch syndrome as it builds additional evidence for an immunotherapy application.

Promega will seek to expand use of the assay in Europe while it works through regulatory review of the test for companion diagnostic use in the US and Asia.

Co-Diagnostics' test, which recently received Emergency Use Authorization in the US, is designed to detect the RdRp gene of the SARS-CoV-2 virus.

News items for the in vitro diagnostics industry for the week of March 30, 2020.

The companies have signed on to a new public-private initiative organized by Wisconsin's governor intended to increase the state's testing capacity.

Promega's microsatellite instability technology will be used to develop an on-label, solid tumor companion diagnostic for pembrolizumab.

The test uses multiplex PCR fragment analysis with Promega-designed five-mononucleotide repeat markers to detect the MSI-high phenotype within tumor tissues.

Novacyt said this week that its revenue from continuing operations for full-year 2018 will be in the range of €13.7 million to €14.4 million ($17.4 million to $18.3 million), following its decision in December to sell its Novaprep cytology business and clinical laboratory operations.

The two companies have signed a collaboration agreement to provide Promega's microsatellite instability testing technology for immuno-oncology.

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