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Lab Developed Tests

Photo of blood samples in test tubes with blue caps in a clinical laboratory awaiting testing for Alzheimer's disease with VeraBIND™ Tau.

First Blood Test to Detect Alzheimer's-Related Tau Pathology

Veravas

VeraBIND™ Tau is a new noninvasive test that offers 96 percent sensitivity and 90 percent specificity, empowering earlier and more accessible Alzheimer's detection

Photo of a medical laboratory professional wearing a white lab coat and standing in the clinical lab with their hands in their pockets.

District Court Overturns FDA’s LDT Rule: What the Ruling Means for Clinical Labs Now

Christine P. Bump

Under the district court’s vacatur, the LDT final rule and its compliance deadlines are no longer in effect and cannot be enforced

The FDA LDT rule would have imposed unnecessary burdens on laboratories, adding requirements beyond existing CLIA regulations.

Texas Court Strikes Down the FDA's Proposed Regulation of Laboratory-Developed Tests

Association for Molecular Pathology

The FDA LDT rule would have imposed unnecessary burdens on laboratories, adding requirements beyond existing CLIA regulations

Photo of the front of the US Capitol Building, the seat of the United States Congress, with a USA flag flying in front and blue sky and clouds in the background. ADLM hosted a congressional briefing on laboratory-developed tests there on February 20, 2025.

Ensuring Quality Pediatric Care Through Laboratory-Developed Tests

Association for Diagnostics and Laboratory Medicine

ADLM congressional briefing explains the importance of laboratory developed tests for pediatric care and the FDA rule that will limit access to these critical tests

A group of red flamingos standing in a pond—flamingos have been known to be infected and die from H5N1 bird flu infection.

Hologic to Contribute to H5N1 Bird Flu Test Development via Agreement Issued by CDC

Hologic

To prepare for if the current H5N1 outbreak worsens, Hologic will work with the CDC to develop reagents that may be used for H5N1 testing

Abstract illustration showing colorful bars representing data from breast cancer testing organized into multiple rows against a dark background.

New Data to Be Presented at SABCS 2024 Investigates the Potential Role of the Breast Cancer Index® Test in Identifying Patients with Minimal Risk of Distant Recurrence

Hologic

Study assesses prognostic value of BCI testing and its potential in supporting de-escalation of primary adjuvant endocrine therapy

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