EXECUTIVE INTERVIEW - ALZpath: A Diagnostic Assay Changing the Future of Alzheimer’s Disease

ALZpath is a diagnostic solutions company committed to improving the lives of people suffering from Alzheimer’s disease and related dementias. They are the developer and provider of a proprietary pTau217 antibody, which is rapidly becoming the new gold standard in blood-based diagnostic tests used to detect the presence and progression of Alzheimer’s disease.

Drug Development & Delivery recently interviewed Jacob Hunter, Chief Business Officer, ALZpath, Inc., to discuss the development and deployment of the company’s proprietary pTau217 antibody, bridging the gap between detection and treatment to improve patient outcomes globally.

Q: What does ALZpath do?

A: Alzheimer’s disease and related dementias affect 55 million people worldwide. Despite its prevalence, nearly 75% of patients, including millions with Alzheimer’s disease, remain undiagnosed, depriving them access to clinical trials, new disease-modifying therapies (DMTs), specialized care, and, most importantly, valuable time as their condition worsens.

Recognizing the global need for accessible, affordable, and non-invasive Alzheimer’s disease diagnosis tools, ALZpath democratizes access to vital diagnostic solutions by entering agreements and partnerships with leading diagnostic assay and analytic platform companies and research institutions. These agreements enable the ALZpath proprietary phosphorylated tau (pTau217) antibody to be incorporated into advanced blood tests and systems used for research and clinical purposes around the world. In doing so, ALZpath aims to support early detection, clinical trial enrollment, and treatment monitoring to improve patient outcomes worldwide.

Q: How was the idea conceived to create ALZpath?

A: In early 2019, researchers began sharing groundbreaking findings that identified blood-based biomarkers – particularly, a protein called pTau217 – as a promising way to diagnose Alzheimer’s disease. These findings were significant and timely, given the rising prevalence of Alzheimer’s disease and related dementias, the inaccessibility and cost of the generally accepted diagnostic standards at the time (cerebral spinal fluid testing or PET imaging), and the advancement of disease-modifying treatments offering new hope for patients – but only when diagnosed.

ALZpath was founded based on the belief that widely accessible, precise blood-based diagnostic solutions would be required to address the lack of timely and accurate diagnoses of Alzheimer’s disease and to make the potentially profound benefit of newer treatments and interventions more equitably and universally available to patients around the world.

Q: Can you tell us your origin story?

A: Eric Reiman, MD, a leading Alzheimer’s disease researcher, collaborated with colleagues on a study affirming that pTau217 diagnostic assays outperformed MRI brain scans and were as effective as PET scans or cerebral spinal fluid testing – the current ‘gold standard’- and could potentially provide patients with accessible, accurate testing in their local doctor’s office.

In 2020, Dr. Reiman, Jerre Stead, and Venkat Shastri founded ALZpath, creating a nimble organization that could collaborate with researchers and scientists on new discoveries and quickly bring diagnostic solutions to market helping support the advancement of a new generation of treatments for Alzheimer’s disease.

Building on prior research and guided by a distinguished group of scientific and clinical experts, ALZpath quickly and effectively designed, developed, and produced its proprietary pTau217 antibody which has proven to deliver significant and consistently reliable sensitivity when incorporated into assays for research and clinical applications across a variety of analytical platforms.

Today, ALZpath’s scientific advisory board includes some of the world’s leading researchers and clinical experts in Alzheimer’s disease and other neurological conditions. The company and its novel, award-winning pTau217 are paving the way for a bright future for the millions of current and future patients and caregivers, utilizing blood-based testing to usher in a new era of diagnosis and treatment for Alzheimer’s disease.

Q: How does the Immunoassay work and how was it developed?

A: The pTau217 immunoassay is built on an ELISA-based sandwich format, known for its reliability and sensitivity in detecting Alzheimer’s disease biomarkers. This antibody is uniquely effective across a variety of diagnostic platforms, whether it’s used on a Quanterix SIMOA® platform, optimized for ultra-sensitive results or on Roche’s high-throughput systems in commercial and clinical laboratories. This versatility makes the assay adaptable to both high-volume and more specialized clinical settings, positioning it as a powerful, non-invasive diagnostic tool for Alzheimer’s disease.

Developing the assay presented unique challenges, especially in ensuring that the antibody could function effectively across multiple diagnostic platforms. ALZpath prioritized consistency and versatility, which has allowed the company to successfully deliver a solution that works across both low and high-volume commercial formats. This approach has been key to securing agreements to integrate the company’s proprietary pTau217 antibody into several leading research use only (RUO), laboratory developed tests (LDT) and in vitro diagnostic (IVD) tests and platforms and ultimately helping ensure widespread access to next-generation treatments and other interventions to improve outcomes for patients.

Q: How does ALZpath connect to drug development?

A: ALZpath and its proprietary pTau217 antibody are uniquely connected across the entire continuum from drug discovery and development to treatment and monitoring. The antibody has been used in assays that were foundational to groundbreaking research into both the diagnosis and treatment of Alzheimer’s disease. It is also incorporated into assays being used for research purposes as well as those currently under regulatory review for approval and use as invitro diagnostics (IVD) worldwide.

The ALZpath pTau217 antibody enters the market at a critical time for expanded and timely detection of Alzheimer’s disease, addressing the pressing need for accessible diagnostic tools. Early diagnosis is the key for patients to benefit from early access to clinical trials, advanced DMTs, specialized care, and improved outcomes.

Early, precise, and more widespread identification allows researchers to enroll more patients in trials for Alzheimer’s disease treatments, and to more accurately understand and measure the impact of treatment and progression of their condition during trials to optimize outcomes.

Q: Can you speak to the business model? What is your process when it comes to licensing agreements?

A: ALZpath’s business model is centered around providing access via licenses to our proprietary pTau217 antibody for RUO, LDT, and IVD use to partners who have the expertise to develop advanced assays incorporating our antibody, pursue and secure necessary regulatory approvals, produce at scale, and bring tests to market efficiently and effectively.

By leveraging the resources and reach of industry leaders, blood-based assays will become more rapidly and widely accessible, accelerating the availability of Alzheimer’s disease testing across various regions, research environments and clinical settings.

ALZpath recently signed licensing agreements with global diagnostics companies Roche and Beckman Coulter who will develop blood tests using ALZpath’s proprietary pTau217 antibody on their globally available platforms. The FDA has granted Breakthrough Device Designation (BDD) to both.

Q: What is the projected impact?

A: Our diagnostic technology has the potential to make a profound impact, particularly in accelerating the use and efficacy of DMTs for Alzheimer’s disease. As we enter a critical period for these treatments, identifying and diagnosing patients earlier is essential to ensure they receive access to clinical trials and treatment and are treated when it is most beneficial. The accuracy and accessibility of assays incorporating ALZpath’s pTau217 antibody means that more patients can be identified at a stage where these DMTs are most effective, improving patient outcomes. Ultimately, ALZpath aims to bridge the gap between diagnosis and treatment, ensuring that patients who need these therapies can access them as soon as possible, to improve care outcomes and quality of life for patients and caregivers.

Q: Can you tell us the future of the antibody/blood-based tests? What is the roadmap?

A: At ALZpath we recognize the profound burden Alzheimer’s disease and related dementias place on individuals, families, caregivers, and communities. We also know that with timely and accurate diagnosis, targeted treatments, education, and comprehensive support, people will increasingly have opportunities to live well even after an Alzheimer’s disease diagnosis.

Achieving this requires fundamentally rethinking the current approach to diagnosis, treatment, and care. With passion, creativity, and perseverance, we are steadfast in our mission to transform the Alzheimer’s disease care paradigm and improve the lives of all those affected by this disease. With our pTau217 biomarker, there are three areas of development at the forefront:

Improving Patient Identification & Selection for Clinical Trials: The incorporation of ALZpath’s proprietary pTau217 antibody into highly sensitive blood-based research assays has and will continue to play a vital role in the development and successful advancement of new treatments for Alzheimer’s disease. More widespread availability of highly sensitive blood-based tests utilizing our pTau217 biomarker will help to increase the percentage and number of patients that receive a timely and accurate diagnosis and can therefore be identified as potentially qualifying for a clinical trial. The success of clinical trials, particularly for a new generation of disease modifying therapies for Alzheimer’s disease, is highly dependent on not only identifying a sufficient cohort of properly diagnosed patients, but also determining precisely where they are in the progression of their disease. Advanced research assays incorporating our pTau217 antibody can accurately detect the presence of Alzheimer’s disease at the earliest stages, even before symptoms appear, helping to ensure that the condition of patients enrolled in trials has not advanced past the point where they are likely to benefit from the treatment. Lastly, the use of these advanced pTau217 blood tests also enables researchers to track the relative progression of Alzheimer’s disease in patients over the course of the trial, thereby helping to generate evidence of whether a particular treatment is effective in slowing or perhaps even halting the progression of the disease, and over what period the impact endures.

Expanding Access in Clinical Settings via Collaboration & Partnerships: ALZpath is currently focused on expanding access through collaboration and partnerships with more IVD companies, broadening our geographical footprint, and incorporating pTau217 testing into additional clinical trials. Just as cancer treatments have evolved over the past 25 years from general chemotherapy to targeted therapies addressing specific mutations, we envision a similar shift in Alzheimer’s disease care toward personalized medicine, which is even more of a reason to ensure pTau217 testing and other blood-based tests are broadly available in the clinical setting.

At-Home Testing: We are exploring potential opportunities to develop and offer at-home testing to expand accessibility of diagnostic tools for Alzheimer’s disease and related dementias. At-home testing offers significant benefits for underserved populations who may face socioeconomic or geographical challenges, provides an additional tool for caregivers and the aging population, and could allow for ongoing treatment monitoring.

Empowered by ALZpath’s success thus far, we remain deeply committed to our mission, and this is just the beginning. With scalable and convenient blood tests for Alzheimer’s disease now within reach, the future of this disease – and its impact on patien – can change dramatically. Earlier diagnosis, coupled with DMTs and other emerging treatments, offers a brighter future for Alzheimer’s disease patients and caregivers.