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The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services...more
The U.S. Food and Drug Administration (FDA) recently released a proposed rule that would seek to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This rule...more