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 ...
Yahoo Finance

Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to diagnose sexually transmitted infections at the point of care

More than 1 million curable sexually transmitted infections (STIs) are acquired every day worldwide in people 15–49 years old, most of which are asymptomatic.1 FDA CLIA-waived tests broaden access to ...
Morningstar%2c Inc.

Clinical Labs Review Proposed Legislation To Modernize Oversight of Lab-Developed Tests Under CLIA

SALT LAKE CITY, June 16, 2026 /PRNewswire/ -- Clinical laboratories, including ARUP Laboratories, are reviewing newly introduced federal legislation to modernize oversight of laboratory-developed ...
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 ...
streetinsider

CytoChip Showcases CLIA-Waived CitoCBC® and Debuts New CitoPRP at ADLM 2025

CytoChip showcases CitoCBC®—the first cartridge-based Complete Blood Count (CBC) analyzer with both FDA 510(k) clearance and CLIA Waiver—and announces CitoPRP, a new cartridge-based system for ...
Yahoo Finance

Global Point-of-Care Glucose Testing Market 2023 to 2030: Introduction of CLIA Waived Tests Drives Growth

Dublin, July 05, 2023 (GLOBE NEWSWIRE) -- The "Point-of-Care Glucose Testing Market Size, Share & Trends Analysis Report By Product (Accu Check Aviva Meter, Onetouch Verio Flex, i-STAT), By Region, ...
Business Wire

Theranos Receives CLIA Waiver, Paving the Way for Greater Accessibility of Health Information at the Time and Place It Matters

PALO ALTO, Calif.--(BUSINESS WIRE)--Theranos, Inc. (Theranos) today announced that its test and Theranos test system for the herpes simplex 1 virus IgG (HSV-1), which was cleared by the U.S. Food and ...
JD Supra

CMS Seeks Broad Stakeholder Input on CLIA Regulations, Signaling Potential Modernization of Current Lab Regulatory Scheme

On July 16, 2026, the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) announced that they are seeking public input on various issues relevant to ...
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) ...
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 ...
Nature

Buildout of an automated high-throughput CLIA lab for SARS-CoV-2 testing on a large urban campus

In 2019, the first cases of SARS-CoV-2 were detected in Wuhan, China, and by early 2020 the first cases were identified in the United States. SARS-CoV-2 infections increased in the US causing many ...