US Medicare beneficiaries will soon be eligible for eight free at-home COVID-19 tests per month.
Starting in early spring, Americans on Medicare – and Medicare Advantage – will be able to receive free over-the-counter COVID-19 tests through their Medicare part B coverage at participating pharmacies and other outlets.
The initiative is part of the Biden administration’s ongoing efforts to expand testing.
The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel
Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.
A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.
