Allarity Therapeutics Announces CLIA Certification, Clearing the Path for Advancing DRP® Testing for FDA Registration

Allarity Therapeutics is now poised to run its DRP® testing in-house in a CLIA-certified laboratory environmentThe FDA requires that ...
Yahoo Finance

Creatv Bio Opens CLIA-Certified Laboratory to Support Oncology Drug Development

MONMOUTH JUNCTION, N.J., May 13, 2026 /PRNewswire/ -- Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv"), a liquid biopsy-based cancer diagnostic testing company, recently opened its full ...
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 ...
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 ...
Becker's ASC

FDA Approves Five New Tests as Waived Under CLIA

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