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OpGen also reported full-year growth was driven by revenue increases for its Acuitas AMR Gene Panel and Acuitas Lighthouse informatics platform.
The assay, which is also CE-IVD-marked, detects SARS-CoV-2 ORF1a and N genes and has a limit of detection of 20 copies per mL using a 400 µL sample.
The firm licensed the assay for detecting SARS-CoV-2 from Hackensack Meridian Health and will adapt it for the T2Dx instrument.
As part of the joint venture, Todos will be responsible for securing US regulatory approval for a coronavirus rapid point-of-care kit.
The deal took effect immediately and shipments have to Spain, France, Germany, and the UK have begun.
The lab is increasing its capacity to 1,000 tests each day with plans to reach 28,000 tests per week in the next few weeks.
SkylineDx said that the firms will work together to develop predictive immunological signatures for BioInvent's lead therapy candidate.
The 45-minute test was developed by BioMérieux subsidiary BioFire Defense and can be used on the company's FilmArray and FilmArray Torch systems.
The 30-minute PCR assay, read visually, uses the company's Accula system, which is designed for use at the point of care.
The Foundation for Innovative New Diagnostics is tracking commercial coronavirus diagnostics development project, with the goal of guiding procurement.
The sequencing-based test is designed to detect mutations that cause resistance to 15 first- and second-line antibiotics used to treat tuberculosis.