News
FDA Clears PrecivityAD2 Blood Test for Alzheimer’s Pathology Assessment
According to Newsweek, C2N Diagnostics has secured FDA 510(k) clearance for PrecivityAD2, a blood-based molecular diagnostic…
News
FDA Shifts Oncology ISH-FISH Companion Diagnostics to Class II Regulatory Status
On August 17, 2026, the U.S. Food and Drug Administration issued a final order that reclassifies a defined family of oncology in…
Molecular Diagnostics
Multiplex PCR Panels: Clinical Impact and Real Utility
A randomized controlled trial published in JAMA Network Open in 2024 found that emergency department patients with suspected…