US commercialisation of FebriDx® to be discussed at Lumos Webinar: Thursday, June 11, at 10:30am AEST

Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) will host a virtual investor briefing on Thursday, June 11, at 10:30am ...
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 ...
Business Wire

Amid National Surge in Sexually Transmitted Infections binx health Announces Launch of Reagent Rental Program for Decentralized, Rapid, Point-of-Care Testing Platform for ...

BOSTON--(BUSINESS WIRE)--binx health, a healthcare technology and women’s health company focused on making routine testing broadly accessible and convenient, announced today the launch of its ...
JD Supra

What the New CLIA Rules Mean for Labs and At-Home Testing

New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became ...
Hosted on MSN

Lumos passes milestone in CLIA waiver study for point-of-care respiratory test

Lumos enrols 61 of required 120 bacterial positive patients in US CLIA waiver clinical study for FebriDx Study to be completed by Q4 2025 with US FDA CLIA waiver application to be submitted in October ...
Nasdaq

Chembio Announces the Receipt of CLIA Waiver for its DPP HIV-Syphilis System

MEDFORD, N.Y., Feb. 24, 2023 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced receipt of a ...
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 ...
RAPS

FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

The US Food and Drug Administration (FDA) on Tuesday finalized two guidances providing recommendation for diagnostics makers looking to submit Clinical Laboratories Improvement Amendments (CLIA) ...
Business Insider

binx health Receives FDA CLIA Waiver for Chlamydia and Gonorrhea Test, Expanding Critical Access to Single-Visit Diagnoses

First ever 30-minute, CLIA-waived, molecular PCR Test for CT/NG now available for OBGYN, physician offices and retail settings holding certificates of waiver BOSTON, March 31, 2021 /PRNewswire/ -- ...
La Grande Observer

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 ...