A new era in Alzheimer’s diagnosis began this year. The FDA granted clearance to two blood biomarker tests for Alzheimer’s disease, moving them from the category of Laboratory Developed Tests (LDTs) to In Vitro Diagnostic (IVD) devices.

This transition isn’t just regulatory paperwork; it’s a critical evolution in making advanced diagnostics more accessible and standardized for primary care providers.

So, what’s the practical difference for clinicians?

LDTs: Developed and performed within a single laboratory. They are essential for rapid innovation, allowing labs like Quest Diagnostics or Labcorp to bring crucial tests to market quickly to meet urgent, unmet clinical needs where no FDA-cleared option exists.

IVDs: Undergo formal FDA review and clearance. This process ensures standardized performance and accuracy across all labs that run the test, enabling broader adoption and integration into healthcare systems nationwide.

Why does this matter for your practice?

Both pathways play a vital, complementary role:

LDTs offer flexibility and speed to address emerging diagnostic gaps.

IVDs provide consistency and scalability, building confidence for wider clinical use.

The clearance of these Alzheimer’s blood tests means primary care teams can now access more standardized, less invasive tools to aid in the diagnostic pathway. It represents progress toward earlier, more accessible detection.

Understanding the evolving diagnostic landscape is key to modern patient care.

To explore the roles of LDTs and IVDs—and their specific impact on neurology and primary care—read the first post in our new blog series.

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