ALZpath Inc.

ALZpath Inc. Named to Fast Company's Most Innovative Companies of 2025! We’re honored to be recognized by FastCompany as one of the World’s Most Innovative Companies of 2025, joining the ranks of NVIDIA, YouTube, and other top innovators shaping the future.? ALZpath’s proprietary pTau217 antibody, already integral to many of the most advanced and widely available blood tests, is transforming early Alzheimer’s disease diagnosis by enabling highly sensitive and accurate detection of a key Alzheimer’s disease biomarker—well before symptoms appear.? With Alzheimer’s disease expected to impact 153 million people globally by 2050, the urgency for accessible, scalable, and non-invasive diagnostics has never been greater. Through partnerships with Roche Diagnostics USA, Beckman Coulter Diagnostics, Bio-Techne, Alamar Biosciences, Inc., and Quanterix, ALZpath is bringing cutting-edge blood-based diagnostics to researchers, clinicians, and patients worldwide.? "Many patients with Alzheimer's today don’t have a clear diagnosis, in part because the most reliable current diagnostic methods are costly, invasive, and can only be administered at specialized facilities," said Mike Banville, CEO & President of ALZpath. "In partnership with leading diagnostic companies, ALZpath is making our best-in-class antibody for detecting Alzheimer’s disease widely available in easy-to-administer, affordable blood tests, which we believe will vastly improve care and outcomes for millions of families facing Alzheimer’s disease.”? "Through our licensing agreements we are empowering researchers, clinicians, and industry partners to accelerate the discovery of new treatments," said?Jacob Hunter, Chief Business Officer of ALZpath. "Critically, this increased access supports the growing urgency to expand blood-based testing in research and clinical settings—enabling early identification of patients for novel treatments that have recently entered the clinical sphere, monitoring treatment response, and building robust evidence for the efficacy of novel therapies. Additionally, these efforts advance our understanding of Alzheimer's disease and validate new targeted approaches to treat and potentially prevent the disease." Being named to Fast Company’s Most Innovative Companies list reinforces our mission to expand access to early, accurate Alzheimer’s disease diagnosis—making detection, treatment, and monitoring more widely available than ever before.? ?? Read the full press release here: https://lnkd.in/gVCcSpic? ?? View the full list from Fast Company here: https://lnkd.in/gatBDGKy #FastCompany #FCMostInnovative #AlzheimersResearch #Innovation #Healthcare #Diagnostics #pTau217

ALZpath Inc. featured in BioQuick News article:?"ALZpath Inc. Making Exciting Progress Toward 'Democratizing' Testing for Alzheimer’s Disease." Our proprietary?pTau217 antibody?is leading the way in?accurate, accessible, and scalable?Alzheimer’s diagnostics—offering a blood-based alternative to PET scans and CSF tests. As new treatments emerge, the need for?early and widely available?testing has never been more critical. With leading global diagnostic partners integrating?pTau217?into their platforms, ALZpath is working to ensure that blood-based testing becomes the standard for?early detection and monitoring.?Recent milestones—including an?FDA breakthrough designation?and new validation studies—underscore the growing impact of our work. ALZpath CEO?Mike Banville?shared: "By diagnosing Alzheimer’s and democratizing access to diagnosis, we wish to establish this antibody as the standard, the flagship if you will, for Alzheimer’s diagnosis as the clinical side starts to ramp up." With the recent?FDA approvals of disease-modifying treatments?like?#Kisunla (donanemab) and #Leqembi (lecanemab), reliable and accessible testing is essential. ALZpath remains committed to ensuring that?individuals worldwide?can access early and effective diagnostics. Read more in BioQuick News:?https://lnkd.in/gCnapRgF #Alzheimers #Diagnostics #HealthcareInnovation #BloodBasedBiomarkers #EarlyDetection #pTau217 #Diagnosis Alzheimer's Association? Alzheimer's Drug Discovery Foundation UsAgainstAlzheimer's

Beckman Coulter Diagnostics?has received?FDA Breakthrough Device Designation?for its?Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test –?A milestone that brings us closer to more accessible and earlier detection of Alzheimer’s disease. This designation?reflects the high diagnostic potential of blood-based biomarkers and was made possible by integrating ALZpath Inc.’s?proprietary pTau217 antibody, licensed to Beckman Coulter to support the development of this innovative assay (on the DxI9000 Immunoassay Analyzer).?Our antibody demonstrates?high diagnostic accuracy, sensitivity, and reliability, enabling clinicians to detect Alzheimer’s disease-related pathology through a simple blood test. This advancement has the potential to enable?earlier detection of Alzheimer’s disease-related pathology,?providing a more accessible, more affordable, and less invasive alternative to procedures such as positron emission tomography (PET) imaging??and cerebrospinal fluid (CSF) analysis in appropriate clinical settings. By providing?reliable, blood-based biomarker insights, this test plays a crucial role in identifying individuals who may benefit from further evaluation, supporting timely diagnosis, and providing access to emerging treatments. Congratulations to Beckman Coulter Diagnostics?on this significant achievement! We’re honored to collaborate in advancing Alzheimer’s disease diagnostics globally.????? ???Learn more: https://lnkd.in/grzTTE_t #Alzheimers #Diagnostics #Biomarkers #Neurodegeneration #BloodTest #BreakthroughInnovation #PatientCare #ALZpath #pTau217

Now Available: Xtalks podcast on?Advancing Alzheimer’s Diagnostics?featuring ALZpath VP of R&D Lee Honigberg. We're excited to share that?Dr. Lee Honigberg,?VP of Research & Development?at?ALZpath Inc., recently joined the?Xtalks Life Science Podcast?to discuss the pioneering work behind our?ALZpathDx assay, a blood-based biomarker test that measures?pTau217—a critical step forward in?early and accessible diagnosis?of?Alzheimer’s disease. Key Highlights: ?? How the?pTau217 biomarker?offers a robust and scalable method for detecting?amyloid pathology, potentially reducing the need for invasive?CSF tests?and costly?PET scans. ??The role of?partnerships with leading institutions?including @Roche Diagnostics?and?@Beckman Coulter?in expanding access to?affordable Alzheimer’s testing. ??A look at the future: Using blood-based diagnostics not only for early detection but also for?monitoring treatment effectiveness?and enabling?prevention trials. Listen to the full episode linked here:?https://lnkd.in/gjwzyvfU At ALZpath, we're committed to?accelerating progress?in Alzheimer’s diagnostics and bringing?hope?to patients, caregivers, and healthcare providers. To learn more about the innovations of ALZpath, visit our website www.alzpath.bio #AlzheimersResearch #Diagnostics #HealthcareInnovation #ALZpath #LifeSciences #Biomarker #pTau217 #Xtalks #Podcast

We are pleased to share that Beckman Coulter Diagnostics?has received?FDA Breakthrough Device Designation?for its?Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test, an important step forward in the early detection of Alzheimer’s disease. This designation reflects the diagnostic potential of blood-based biomarkers and was made possible through the integration of?ALZpath Inc.’s proprietary pTau217 antibody, licensed to Beckman Coulter to support the development of this innovative assay?on their DxI9000 Immunoassay Analyzer.?Selected after rigorous evaluation, our pTau217 antibody has demonstrated?high diagnostic accuracy, sensitivity, and reliability?in detecting Alzheimer’s disease-related pathology. At?ALZpath, we are proud that our antibody is integral to assays like Beckman Coulter’s, enabling broader access to?non-invasive, precise diagnostic tools. As we continue to expand access to next-generation biomarker testing, we remain committed to supporting clinicians, researchers, and industry partners in the fight against Alzheimer’s disease. Congratulations to?Beckman Coulter Diagnostics?on this significant milestone! We’re honored to collaborate in advancing Alzheimer’s disease diagnostics globally.?????? ?? Learn more: https://lnkd.in/grzTTE_t #Alzheimers #Diagnostics #Biomarkers #Neurodegeneration #BloodTest #BreakthroughInnovation #ALZpath #pTau217

Excited to hear Dr. Lee Honigberg, our VP of Research & Development, share how ALZpath Inc.’s pTau217 antibody is driving innovation in Alzheimer’s research and patient care. Tune in for valuable insights!

Congratulations to Professor Kaj Blennow, advisor on ALZpath Inc.’s Scientific Advisory Board, on receiving the Rainwater Prize for Outstanding Innovation in Neurodegenerative Research?for his?transformative?work in Alzheimer’s diagnostics! ? Dr. Blennow’s pioneering research has transformed how #Alzheimer’s disease is detected and studied, reinforcing the growing role of #pTau217 blood tests in early and accurate diagnosis.? ? We’re proud to have his expertise guiding our work at ALZpath and shaping the future of Alzheimer’s disease research.?? ? #NeurodegenerativeDiseases #Research #RainwaterPrize #ALZpath?

A recent study published in the Alzheimer's Association?'s journal of Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring?highlights the robust performance of the ALZpath Inc. pTau217 assay?reinforcing its role as a transformative tool for early and accurate Alzheimer’s disease (AD) diagnosis. Conducted by Neurocode Labs, Inc., the study compares two leading lab-developed pTau217 assays—ALZpath and Fujirebio—and demonstrates that the ALZpath assay delivers?superior diagnostic performance, particularly in earlier stages of the?disease. This is critical for timely treatment intervention and ultimately, improved patient outcomes. As Alzheimer’s disease diagnostics continue to advance,??blood-based biomarkers like the ALZpath pTau217 assay are leading the way. With this assay currently available for clinical testing through Neurocode Labs, Inc., healthcare providers have an accessible, highly accurate blood test to support AD diagnosis. ???Learn more about the innovative study here:?https://lnkd.in/gvxtQEHB #Alzheimers #Biomarkers #pTau217 #AlzheimersDiagnosis #Neurodegeneration #Innovation

We are proud to share that ALZpath Inc.’s pTau217 antibody has been named a finalist for the 2025 Edison Awards!? This recognition highlights the impact of our antibody in advancing Alzheimer’s disease diagnostics. As a key biomarker for early detection, pTau217 enables more accessible, accurate, and scalable testing—helping to advance early intervention and improve patient outcomes. The Edison Awards honor the world’s top innovations, celebrating breakthroughs that push industries forward. Finalists have been chosen by a panel of industry leaders, researchers, and visionaries, making this nomination a true testament to the impact of our work.? We’re honored to be included alongside so many incredible innovations—congratulations to all the finalists. Stay tuned for the final award results this April! ???Learn more: https://lnkd.in/g3MvKuyi #EdisonAwards #Alzheimers #Innovation #Biomarker #Diagnostics #ALZpath

The Alzheimer's Drug Discovery Foundation (ADDF) Diagnostics Accelerator (DxA) has announced a landmark $10M investment in?Alamar Biosciences, Inc., the largest in DxA history.?This funding will expedite the translation of the?Alamar?ARGO??HT?research platform into an FDA-cleared system to support the development of in vitro diagnostic (IVD) tests – the gold standard of diagnostics. Alamar's ARGO? HT System features the?ALZpath pTau217 antibody?in their?NULISAseq? CNS Disease Panel 120?and?NULISAqpcr? pTau-217 assay, enhancing Alzheimer’s?disease?biomarker detection with ultra-high sensitivity and multiplexing. This milestone investment aligns with DxA’s mission to accelerate accessible and scalable diagnostics.?ALZpath?is proud to contribute innovative biomarker solutions that support early and accurate diagnosis. Stay tuned for more updates on this exciting collaboration. ?? Read more here:?https://lnkd.in/gvR4DS8Z #pTau217 #Biomarkers #BiomarkerResearch #AlzheimersResearch