Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Avacta Obtains CE Mark for SARS-CoV-2 Antigen Test
The firm said it has ongoing commercial discussions for its lateral flow antigen test with distributors and end users in countries that accept the CE mark.
Lucid Diagnostics Obtains CE Mark for Esophageal Cancer Molecular Test
Lucid said that key opinion leaders for esophageal disease in Europe are participating in pivotal clinical trials for the test and its collection device.
FDA Warns Against Use of Innova Medical Group SARS-CoV-2 Antigen Test
Innova had been selling the test in the US despite never having received marketing approval, clearance, or authorization, according to the FDA.
Castle Biosciences Receives NYS DOH Approval for Skin Cancer Diagnostic
The company's DecisionDx-SCC is meant to predict risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors.
Promega Receives CE Mark for SARS-CoV-2 Antibody Test
The bioluminescent SARS-CoV-2 immunoassay enables scalable detection of antibodies against the receptor-binding domain antigen of the SARS-CoV-2 spike protein.