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.
Emmaus Life Sciences' Endari label enhancements receive US FDA approval
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
CARsgen Therapeutics' satri-cel NDA accepted by Chinese regulator
Sanofi receives FDA orphan drug designation for riliprubart in transplant rejection
Hoth Therapeutics reports positive interim results for HT-001 topical therapy
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Hemab Therapeutics presents bleeding disorder clinical and preclinical data at ISTH 2025 Congress
Cumberland Pharmaceuticals reports ifetroban Phase 2 DMD heart disease trial results
Sarclisa recommended for EU approval in newly diagnosed transplant-eligible multiple myeloma