Policy Updates

12/7/21 — As the SARS-CoV-2 virus continues to mutate over time, genetic variations could impact the performance of some COVID-19 molecular, antigen, and serology tests. The FDA website “SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests” provides information regarding the impact of viral mutations on COVID-19 tests, recommendations for clinical laboratory staff and healthcare providers, and information … Continued

12/6/21 — Federal Courts have suspended implementation of the OSHA COVID-19 Vaccination and Testing Emergency Temporary Standard and the CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule until the courts can review and rule on challenges to the mandates. Both agencies remain confident of their authority to implement necessary measures to protect the health … Continued

12/3/21 — The FDA revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who … Continued

11/23/21 — The FDA authorized three over-the-counter (OTC) COVID-19 antigen diagnostic tests for people age 14 years or older with a self-collected nasal swab sample or people age 2 years or older when an adult collects the nasal swab sample. These tests are: InBios SCoV-2 Ag Detect Rapid Self-Test delivers results in about 20 minutes. The … Continued