Breaking the PCR-Only Barrier: Dual 510(k) Clearance and CLIA-Waiver Establish FINDER as the First Molecular Point-of-Care Platform with Multifunctional Capabilities

Baebies announced FDA 510(k) clearance and CLIA-waiver approval for the FINDER® Flu A&B/SARS-CoV-2 Test, an ultra-rapid ...
Purdue University

Amplified Sciences earns CLIA certification for its first test to assess pancreatic cancer risk

WEST LAFAYETTE, Ind. — Amplified Sciences, a clinical-stage life sciences diagnostic company that develops tests for early, more accurate detection of challenging diseases, starting with pancreatic ...
Business Wire

Celerion Achieves Milestone With CLIA Certification for Its Bioanalytical Laboratory, Expanding Capabilities in Clinical Trials and Diagnostic Testing

LINCOLN, Neb--(BUSINESS WIRE)--Celerion, a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) ...
Nasdaq

QuidelOrtho's (QDEL) Rapid Antigen Test Gets CLIA Waiver

QuidelOrtho Corporation QDEL recently announced that it has been granted a CLIA Waiver by the FDA, which applies to its new Sofia 2 SARS Antigen+ FIA (fluorescent immunoassay). The Sofia 2 SARS ...

Lumos Diagnostics Holdings Limited (LDXHF) Discusses CLIA Waiver Clearance for FebriDx, Capital Raise, and Commercialization Strategy Transcript

Discusses CLIA Waiver Clearance for FebriDx, Capital Raise, and Commercialization Strategy March 30, 2026 6:00 ...

Roche expands mass spectrometry menu to include steroid assays receiving CLIA 'moderate complexity' designation

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has categorized its ...

Acrivon Therapeutics Strengthens its Precision Medicine Therapeutics Capabilities with Launch of Internal CLIA-Certified Laboratory

Wholly-owned laboratory has received CLIA certification from Massachusetts with full license to conduct patient testing and ...
Business Wire

Executive War College to Address, Clinical Laboratories’ and Genetic Testing Firms’ Perfect Storm, involving FDA’s Proposed LDT Rule, Payers Requiring Z-Codes on Genetic ...

Executive War College to Address, Clinical Laboratories’ and Genetic Testing Firms’ Perfect Storm, involving FDA’s Proposed LDT Rule, Payers Requiring Z-Codes on Genetic Test Claims, and Revisions to ...