Business Wire

Sapient’s High Complexity CLIA Laboratory Receives Accreditation from the College of American Pathologists (CAP)

SAN DIEGO--(BUSINESS WIRE)--Sapient, a biomarker discovery organization providing bespoke services for metabolomics and lipidomics data generation and analysis, announced that its high complexity CLIA ...
Business Wire

Gather Labs Opens Its Doors in Beverly Hills, Providing Full Lab and COVID-19 Testing Services On-site With No Hassle or Waiting

Woman Founded and Operated, Gather Labs is the First High Complexity CLIA Laboratory and Clinic in Los Angeles County Offering COVID Testing By Appointment with Results in as Little as 10 Minutes, ...
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, ...
JD Supra

Unpacking Averages: Assessing FDA’s Performance Categorizing New Diagnostic Tests Under CLIA

This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). The answer is that, on average, the ...
JD Supra

Thinking of Using Serology Testing for COVID-19? Don’t Overlook CLIA Certification Rules

With the spread of COVID-19, healthcare providers—including those that are more easily accessible to patients, like primary care practices and urgent care clinics—are looking for fast and reliable ...