LAB-DEVELOPED-TESTS

Moving your laboratory-developed test to IVDR compliance with Twist Bioscience and Platomics

FDA plans to boost oversight of lab-developed tests

FDA Releases Laboratory-Developed Tests Final Rule - Thought Leaders in Health Law®

Regulation and Reimbursement for Lab Developed Tests: A Critical Policy Update

MolDx Z-Code Lab Developed Test Registration Questions: A Walkthrough

Inside the Mayo Clinic Diagnostic Testing Labs

COVID-19 Lab-Developed Tests: The FDA's Evolving Approach

COVID-19 Lab Developed Tests Policy Reversal: How Did We Get Here?

Part 2: The Theranos Loophole & Lab Developed Tests

New Federal Oversight of Lab Developed Tests

Proposed Regulations for Laboratory Developed Tests: Bill Morice, M.D., Ph.D.

MEDIA CALL: Lab Developed Tests – 9/29/2023

Validation of RT PCR technology as a Lab Developed Test for COVID-19 detection in a clinical setting

FDA's Initiative to Regulate Lab-Developed Tests (LDT) Will Harm Patients and Academic Pathology

Laboratory Developed Tests : Challenges and Opportunities

First Lawsuit Against the FDA for its New Rule on Lab Developed Diagnostic Test

AACC-ACMG-AMP-APC Webinar: Regulation of Lab Developed Tests – Module 2: Importance to Clinical Care

How the VALID Act, if Passed, Can Harm Patient Access to Life-Saving Tests

TRAILER: An Interview With Dr. Genzen: Answering Your Questions About the FDA’s Final Rule on LDTs

AACC-ACMG-AMP-APC Webinar: Regulation of Lab Developed Tests – Module 3: Current Policy Proposals

Katie Serrano - Keynote - FDA’s Proposed Framework for Regulatory Oversight of Laboratory Developed

What Are LDTs—and Why Should You Care?

AACC-ACMG-AMP-APC Webinar: Regulation of Laboratory Developed Tests – Module 4: Advocating for LDTs

#340: LDTs & the FDAs Proposed Ruling