The Warsaw, Poland-based startup expects to submit a rapid SARS-CoV-2 molecular test for EUA and is seeking US manufacturing and distribution partners.
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.
The panel can detect and differentiate SARS-CoV-2 and 20 other pathogens known to cause serious respiratory disease from nasopharyngeal swabs in symptomatic patients.
The firm's tick-borne pathogens panel was also recently the subject of a clinical study, showing high accuracy in detecting numerous infectious agents.
