Korean molecular diagnostic company Gencurix Inc reported on Wednesday that the US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its GenePro SARS-CoV-2 Test, a diagnostic kit for COVID-19.
This is the second RT-PCR test launched by Gencurix following its first test assay, GenePro COVID-19 Detection Test, which was released in March.
Advantages of the GenePro SARS-CoV-2 Test include simultaneous monitoring of up to 384 samples, allowing high throughput screening of the novel coronavirus.
With the FDA's EUA, Gencurix is now able to provide its COVID-19 detection tests across the United States.
Shanton Pharma completes SAP-001 End-of-Phase 2 meeting with US FDA
Eli Lilly's single-injection, once-monthly maintenance Omvoh regimen receives US FDA approval
4basebio synthetic DNA used in Phase I/II mRNA therapy trial
Spinogenix to present SPG601 Phase 2a trial results at AACAP Conference
AnnJi Pharmaceutical secures FDA Fast Track Designation for AJ201 in rare neuromuscular disease
Myosin Therapeutics' MT-125 granted US FDA Fast Track designation in glioblastoma
Boehringer Ingelheim's JASCAYD (nerandomilast) IPF treatment gains Chinese regulatory approval
Galera Therapeutics sells dismutase mimetics portfolio to Biossil in USD108.5m agreement
Arcturus reports interim Phase 2 data for ARCT-032 in cystic fibrosis