Business is booming for the at-home diagnostic test kit industry ... are likely to tout them in their marketing materials. You can also check if a particular test is cleared by the FDA by ...

First Blood-Based In-Vitro Diagnostic Test to Receive FDA Clearance for Patients Being Assessed for Alzheimer’s Disease. — —Availability of Accurate, Accessible, Blood-Based Diagnostic Tests ...

Each guide will contain a set of general principles ... marketing purposes, companies often fund physicians to conduct studies to demonstrate the utility and potential impact of the diagnostic test.

WHEN a new test for a disease is being evaluated it is customary to perform the test in two selected groups of subjects: those with an indisputable diagnosis of the disease by other criteria ...

But it's not for everyone. The FDA granted marketing authorization for the diagnostic test, the Visby Medical Women’s Sexual Health Test, to Visby Medical on Friday. The at-home kit, according ...

The US Food and Drug Administration has given marketing clearance to a blood test to help diagnose Alzheimer ... additional regulatory approvals of diagnostic tools.” ...

Bashir’s team created a CRISPR-based diagnostic test that bypasses that amplification step by combining two CRISPR/Cas units in a complex called CRISPR-Cascade. One unit contains a guide RNA ...

Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) ...

But it's not for everyone. The FDA recently granted marketing authorization for the diagnostic test, the Visby Medical Women’s Sexual Health Test, to Visby Medical. The at-home kit, according to ...