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 develop companion ...
Medindia

Drug Test Cups Designed for Accuracy and Compliance

Drug test cups remain a frontline tool for employers, clinics, and occupational health providers who need fast, reliable urine screening ...
The Financial

Roche receives FDA CLIA waiver for flu A/B test for use on its cobas Liat PCR System

The FINANCIAL — Roche on September 22 announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas Influenza A/B test ...
Nasdaq

Axim Biotechnologies Files Pre-Submission With FDA for CLIA Waiver Pathway on Lactoferrin Point-of-Care Diagnostic Test

SAN DIEGO, CA - June 24, 2025 (NEWMEDIAWIRE) - Axim Biotechnologies, Inc. (OTCQB: AXIM), a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it has ...
Precision Medicine Online

Acrivon Therapeutics to Open CLIA-Certified Lab to Run Diagnostics for Targeted Therapies

The driving force behind the lab was a desire to control biomarker discovery, streamline regulatory approvals for CDx, and develop drugs more cheaply and quickly.
360Dx

Lex Dx Wins FDA 510(k) Clearance, CLIA Waiver for Point-of-Care PCR System, Respiratory Test

NEW YORK – Lex Diagnostics said on Monday that it has obtained 510 (k) clearance and CLIA waiver from the US Food and Drug Administration for its Velo point-of-care molecular diagnostic system and an ...
WNCT

CytoChip Receives FDA Clearance and First CLIA Waiver for a Cartridge-Based Complete Blood Count Test

The CLIA-waived CitoCBC® expands patient access to quick CBC results in physician offices, pharmacies, and home care, enabling data-driven diagnostics. CBC is one of the most commonly requested lab ...
abc27

Visby Medical™ Receives FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

SAN JOSE, Calif., Feb. 26, 2025 /PRNewswire/ -- Visby Medical ™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration (FDA) for ...
Morningstar

Roche achieves first CLIA 'Moderate Complexity' categorization for Ionify® 25-Hydroxy Vitamin D total test

First mass spectrometry-based test system for total 25-Hydroxyvitamin D to receive CLIA 'Moderate Complexity' designation in the U.S. Expands access to advanced testing with a fully automated, ...