TLDR; Our Top Stories of 2025

This past year will be remembered as a year of dramatic regulatory shifts and an industry-wide pivot toward modernization. Here’s a quick roundup of the stories that captured the most attention in 2025.

The essential stories defining the year in the clinical lab:

1. Texas Court Strikes Down FDA LDT Regulation

Why it matters: A federal court ruling in Texas abruptly halted the FDA’s attempt to regulate laboratory-developed tests as medical devices, delivering one of the most consequential legal decisions for clinical labs in 2025. 

By vacating the agency’s final rule, the court reaffirmed that LDTs fall under CLIA oversight rather than FDA device authority, preserving the long-standing regulatory framework labs rely on. 

The decision spared laboratories from costly new compliance requirements and reshaped the national conversation around how—and by whom—LDTs should be regulated moving forward.

2. Are We in a ‘Quademic’? COVID-19, Flu, RSV, and Norovirus Infections Surge

Why it matters: In 2025, the US and other regions faced an unusual convergence of multiple viral threats—COVID-19, influenza, respiratory syncytial virus (RSV), and norovirus—all circulating at elevated levels during the winter season. 

This quadruple surge, coined a “quademic,” highlighted how overlapping infectious disease waves can strain clinical testing resources, complicate diagnoses, and increase lab demand for timely, accurate pathogen identification. 

The CDC’s tracking of norovirus alongside the more familiar respiratory viruses underscored the need for robust surveillance, integrated testing strategies, and ongoing investment in molecular diagnostics and public health preparedness.

3. What BD Selling Its Diagnostics Business Could Mean for Clinical Labs

Why it matters: What began as a strategic review in early 2025 has since evolved into a definitive plan to separate BD’s diagnostics and biosciences business and combine it with Waters Corporation, creating a new standalone life sciences and diagnostics company. 

The move signals a major reshaping of the IVD vendor landscape, with implications for product portfolios, customer support, and long-term investment priorities. 

For clinical labs, the transaction underscores ongoing consolidation in diagnostics—and raises questions about continuity, innovation, and vendor relationships as the deal moves toward an expected 2026 close.

4. Top 5 Clinical Trials Shaping Medicine in 2025

Why it matters: 2025 also saw several high-impact clinical trials underway that could redefine how medicine is practiced. 

From gene therapy for prion disease and base editing in sickle cell disease to radiopharmaceutical advances in prostate cancer, these studies illustrate how precision diagnostics and novel treatments are moving from concept to clinical reality. 

Notably, trials pairing AI-driven tools with at-home cancer screening and personalized breast cancer risk approaches signal shifts not only in therapy but also in how labs and clinicians detect disease early and tailor care—underscoring the evolving role of laboratory science in shaping future standards of care.

5. First Blood Test for Endometriosis Now Available in the US

Why it matters: After decades of reliance on invasive surgery to diagnose endometriosis, 2025 saw the launch of EndomTest™, the first noninvasive blood test for the condition now commercially available in the US. 

The new assay, offered through a CLIA‑certified and CAP‑accredited lab, measures specific biomarkers and uses an algorithmic approach to provide a reliable diagnostic result from a simple blood sample. 

The test is a potential game‑changer for the estimated 6.5 million women in the US affected by the disease, for whom diagnosis has historically taken an average of seven years.