Under a settlement, Yikon agreed to immediately stop advertising, marketing, and selling its serology test kits and to refund customers who purchased them.
The anti-SARS-CoV-2 antibodies for classes IgA and IgG are two of the first antibody detection tests to receive CE making and be made available for SARS-CoV-2 testing.
ARUP partnered with BioMarin to develop the blood-based assay, which is intended to identify those patients most likely to respond to the drug firm's AAV5-based gene therapy.
The anticipated shortage for clinics comes at a time when more clinicians are already switching to lab-based IGRA testing, diagnostic industry executives said.
