FDA Watch: Key Lab Test Clearances of 2023
G2’s list of major FDA approvals includes cancer and liquid biopsy, COVID-19, STI, and neurologic tests.
Already a member? Log in here
The Future of Laboratory-Developed Tests
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
Already a member? Log in here
Diagnostics Pipeline: FDA Opens Path for Blood Tests Assessing Genetic Cancer Risk
First marketing authorization of a blood test assessing genetic variants related to cancer opens the door for clearance of similar tests.
Already a member? Log in here
FDA Watch: Agency Opens New Pathway for STI At-Home Sample Collection Kits
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
Already a member? Log in here
The Diagnostics Pipeline: FDA Approves First Ever Fentanyl Test Strips for OTC Use
Approval for OTC use of a urine drug test that can be performed by non-CLIA facilities could help expand accessibility, expert says.
Already a member? Log in here