Lab Developed Tests News, Articles

Image of the US White House. Clinical labs are wondering how incoming President Donald Trump might influence LDT changes.

Will President-Elect Donald Trump Change the FDA’s LDT Final Rule?

Scott Wallask, BA

Clinical labs eager for relief from upcoming FDA compliance dates are looking to the new presidential administration

Image of pegs surrounding money. Crowdfunding assays for UTIs are the initial offering from LISA in response to the FDA’s LDT final rule.

Initial Crowdfunding Assays Are Now Available in Response to LDT Final Rule

LISAbio

LISA heads up new effort with UTI assays designed to comply with the FDA’s regulations for lab-developed tests

Image showing coins surrounding an idea lightbulb. The Laboratory Integration Strategic Association is leading an effort to crowdsource LDT development in reaction to FDA regulations.

First Ever Effort to Crowdfund Diagnostic Assays Launches in Response to FDA LDT Final Rule

LISAbio

LISA CEO explains why crowdfunding is a viable way to shoulder the new regulatory costs behind laboratory-developed tests

Two clinical laboratory scientists wearing PPE in the laboratory hold a clipboard and review the milestones toward the new FDA LDT Final Rule.

Navigating FDA’s LDT Final Rule: Key Terminology Every Clinical Lab Should Know

Shannon Bennett, MS, MBA

As the first milestone of the new LDT Final Rule approaches, here are the key FDA terms laboratories need to understand

Webinar Recap: LDT Compliance Requirements for FDA Final Rule

Christine P. Bump

Christine P. Bump shares key insights from the FDA’s August 22 webinar on LDTs compliance

Photo of the letters F, D, and A, representing the US FDA, on wooden blocks with pills in the background.

Association for Molecular Pathology Challenges FDA in Lawsuit against Final Rule on Laboratory-Developed Test Regulation

Association for Molecular Pathology

Drastic policy change will stifle diagnostic innovation, impose billions of unnecessary dollars in healthcare mandates, and threaten patient access to essential medical procedures

Photo of the word “regulation” in bold capital letters on the side of a file folder.

FDA's Draft Guidances for Emergency Use LDTs Spark Mixed Reactions

Julie Ballard

Public comments to the FDA’s draft guidances proposing enforcement policies for LDTs with and without a 564 Declared Emergency reveal a mix of support and opposition

Photo of a clinical lab professional typing at a laptop keyboard with legal symbols overlayed on top of the photo.

ADLM Supports Letter Asking How the FDA Plans to Abide by SCOTUS Decision Limiting Power of Federal Agencies

Octavia Peck Palmer, PhD

In a statement, ADLM president Octavia Peck Palmer strongly supports Rep. Cassidy’s letter to the FDA asking how the agency plans to change its current practices under the recent Supreme Court ruling