The firm expects to launch a 510(k)-cleared version of its Bladder EpiCheck recurrence assay early next year followed by an RUO early-stage lung cancer assay.
Children's Hospital Los Angeles used a SARS-CoV-2 sequencing panel to determine if patients had become infected from the same source as healthcare workers.
The UK Department of Health and Social Care has already ordered 10,000 RNA test cartridges from the company, which expects to obtain a CE-IVD mark for its test within weeks.
Fluidigm's Biomark HD microfluidic platform will enable more than 180,000 real-time PCR tests to be run over the next 90 days to potentially support COVID-19 screening.
The researchers said their assay can be run in 30 to 45 minutes, with 95 percent positive predictive agreement and 100 percent negative predictive agreement.
The company's approach relies on an initial point-of-care lateral flow assay followed by a confirmatory real-time PCR analysis run in its laboratories.
