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The draft guidance focuses on therapies that target a specific genetic, cellular or molecular abnormality and are designed to correct or modify the underlying cause of disease.

FDA Fast-Tracks Ultra-Rare Therapies with Plausible Mechanism Guidance

U.S. Food and Drug Administration

Framework enables approval of individualized genome editing and RNA-based treatments when traditional trials aren’t feasible

Despite ongoing efforts to improve it, around 90 percent of clinical drug development still fails.

Regulating the Future: How the FDA Is Defining the Role of AI in Clinical Development

Gen Li, PhD, MBA

The FDA is embracing a data-driven, patient-centered approach to clinical trials

Currently, LDTs can be created and implemented in a matter of weeks or months.

Why Clinical Labs Must Still Lead on Laboratory-Developed Test Quality

Shawn Hood

Oversight of the laboratory testing field must balance safety with speed and innovation

It’s impossible to foresee every government or regulatory body change regarding LDTs, so it is best to boost documentation, quality, and consistency where possible now.

FDA LDT Rule Reversal Signals Return to Innovation, Flexibility, and Established Regulation

Greer Massey, PhD

The innovative capabilities of LDTs should endure as long as the field remains data-driven, standards-compliant, and committed to continuous quality improvement

Despite the alarming statistics, many sepsis-related deaths are preventable through rapid diagnosis and treatment.

Challenges and Advances in Sepsis Detection

Zahraa Chorghay, PhD

FDA-approved tests like Intellisep and TriVerity™ demonstrate potential for early sepsis diagnosis

This marks a significant milestone for clinical laboratories in the United States.

AliveDx's MosaiQ® Platform Registered with FDA as Class II 510(k) Exempt, Enabling US Labs to Adopt High-Throughput Automated Immunoassay Testing

AliveDx

MosaiQ is a next-gen immunoassay platform delivering automated, multiplexed testing and actionable insights for complex conditions

The new designation adds to growing evidence of the value of the Haystack MRD test for both clinical and pharmaceutical applications.

FDA Grants Breakthrough Device Designation for Haystack MRD Circulating Tumor DNA Test from Quest Diagnostics

Quest Diagnostics

Could this new test change how early-stage colorectal cancer is treated and improve patient outcomes?

FDA Clears First TAGS-Powered Respiratory Panel for Simultaneous Detection of SARS-CoV-2, Flu, and RSV

Roche

Cleared for use on Roche’s cobas® systems, the new PCR test supports syndromic respiratory diagnostics with customizable panels and digital reflex capability

Rapid in-house companion diagnostics can transform lab workflows and help pharma reach more patients, faster.

FDA Approves NGS Companion Diagnostic for ZEGFROVY and Tumor Profiling

Thermo Fisher Scientific

Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer generates results in as little as 24 hours to support timely therapy decisions

Untangling Uncertainty: What's Next in Clinical Lab Compliance

Today's Clinical Lab

Join Today's Clinical Lab and a panel of regulatory and industry experts as they explore what’s ahead in laboratory compliance—and what labs need to know right now

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