And consolidation in the diagnostics space is only just beginning.
Non-Covid-19 medical device approvals tick up alongside the agency’s pandemic efforts.
Chembio’s antibody test is the first to have its authorisation revoked. It might not be the last.
Robust specificity data mark Roche’s serological test out as a major competitor.
With the prevalence of coronavirus infection running at about 5%, test manufacturers and regulators alike will have to guard against false positives.