ALZpath

September is World Alzheimer’s Month—a time to recognize the millions of people living with Alzheimer’s disease and the clinicians working to provide patients and families with timely, accurate answers.

The past month has demonstrated how quickly the diagnostic landscape is evolving. From the FDA clearance of the ALZpath powered Roche’s Elecsys® pTau217 assay to expanding availability through leading laboratories, blood-based biomarkers are moving closer to routine clinical practice.

For clinicians, this progress could support a more accessible and scalable approach to assessing amyloid pathology and help inform appropriate next steps in the diagnostic pathway.
At ALZpath, we are proud to see our pTau217 antibody contributing to this progress through partnerships focused on expanding access across diagnostic platforms, laboratories and healthcare settings worldwide.

This World Alzheimer’s Month, we remain focused on helping bring the science of blood-based biomarkers into clinical care—so more clinicians can access the tools they need and more patients and families can move forward with greater clarity.

For clinicians evaluating patients with cognitive decline, a new FDA-cleared blood test offers another option for assessing amyloid pathology associated with Alzheimer’s disease.

This week, Roche Diagnostics USA received FDA clearance for the Elecsys® pTau217 blood test, developed using ALZpath’s proprietary pTau217 antibody. Labcorp and Quest Diagnostics have also announced plans to offer the test, helping expand access across the United States.

The test is intended to aid clinicians across primary and specialty care in evaluating adults aged 55 and older with signs, symptoms or complaints of cognitive decline.

Bringing pTau217 testing to Roche’s widely available, fully automated Elecsys® platform marks another important step toward broader clinical adoption of accurate, scalable blood-based testing.

We are proud to see ALZpath’s technology helping make this advancement possible and grateful to the Roche and ALZpath teams whose collaboration brought it to this point.

Most importantly, this milestone gives clinicians a minimally invasive tool to support the evaluation of patients with cognitive impairment and help guide the next steps in their care.

🔗 Learn more: https://diagnostics.roche.com/us/en/news-listing/2026/fda-elecsys-ptau217-alzheimers-blood-test.html?utm_source=linkedin&utm_medium=organic&utm_campaign=alzheimers-2026_2950805404&utm_content=organic-post

ALZpath Signs Global Licensing Agreement with Abbott to Advance Blood-Based Alzheimer's Disease Testing

We are pleased to announce a new licensing agreement with Abbott, a global healthcare leader, to incorporate ALZpath's proprietary pTau217 antibody into the development of an in vitro diagnostic (IVD) test for Alzheimer's disease.

The test would be designed for use on Abbott’s Alinity ci-series systems, which represents one of the largest install bases of immunoassay instruments worldwide. As blood-based biomarkers continue to transform the Alzheimer's disease diagnostic landscape, collaborations like this help bring the field closer to a future where accurate, accessible testing can support earlier evaluation and informed care decisions for more patients.

"This agreement further strengthens ALZpath’s leadership in blood-based Alzheimer’s testing and reinforces our position as the foundational component supporting the overwhelming majority of the pTau217 IVD market," said Mike Banville, CEO of ALZpath. "Together with our diagnostic partners, we remain focused on bringing our highly accurate and sensitive antibody into routine care, including primary care, to reach patients in need."

We look forward to working with Abbott to help advance the next generation of Alzheimer's disease diagnostics.

🔗 Read the full release: https://alzpath.bio/alzpath-signs-global-licensing-agreement-with-abbott-to-advance-blood-based-alzheimers-disease-testing/

Earlier answers start with better access.

In a recent interview with MedTech Spectrum, ALZpath CEO Mike Banville discussed how blood-based biomarkers are helping make Alzheimer's disease testing more accessible and practical for patients and healthcare providers.

As Mike shared:
"Earlier identification of amyloid pathology has the potential to fundamentally reshape Alzheimer's disease management by enabling intervention earlier in the disease continuum."

As blood-based Alzheimer’s disease testing continues to advance, it has the potential to support earlier evaluation of Alzheimer's disease pathology and help more people access the information they need to make informed decisions about their care.

Read the full interview: https://medtechspectrum.com/interviews/22/25623/advancing-alzheimers-diagnosis-through-accessible-blood-based-biomarkers-.html

Advancing Alzheimer’s Diagnosis Through Accessible Blood-Based Biomarkers Advancing Alzheimer’s Diagnosis Through Accessible Blood-Based Biomarkers

🧠 June is Alzheimer's & Brain Awareness Month.

This month, we recognize the individuals, families, caregivers and communities impacted by Alzheimer's disease, along with those dedicated to advancing awareness, research, diagnosis, and care.

Together, we are building a future of earlier answers, more informed care, and greater hope.

Showing at AD/PD 2026 signals blood-based Alzheimer’s testing is moving closer to routine care and ALZpath is helping define the standard.

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