Can a New Alzheimer's Test Pave the Way for Next-Generation Therapies?

The complexity of diagnosing Alzheimer's disease has long constrained the advancement of treatment options—finding the right drug for the right patient at the right time has always been a core challenge in this field.

Although combination testing allows doctors to determine whether symptomatic patients have Alzheimer's disease, this determination often comes too late. And the FDA-approvedblood tests, which work by detecting amyloid plaques in the brain, align with the mechanisms of approved anti-amyloid drugs such as Eisai and Biogen's Leqembi and Eli Lilly's Kisunla.

However, the pathology of Alzheimer's disease goes far beyond amyloid plaques. With dozens of candidate drugs targeting tau protein and other potential disease markers entering the pipeline, pharmaceutical companies and clinicians urgently need new testing methods to precisely identify patient populations most likely to benefit.

Josh Soldo, chief scientific officer and co-founder of Veravas, says finding these markers is like looking for a needle in a haystack. The company's blood test is designed for tau pathology detection in presymptomatic Alzheimer's patients.

Veravas' testing platform, called Verabind Tau, is designed to "remove the haystack to make the needle easier to find." By isolating and measuring tau protein circulating in the blood, and further distinguishing which of these are in an activated state and more likely to lead to cognitive decline, the blood test showed more than 95% sensitivity and 95% specificity inresultspresented at the 2025 Alzheimer's Association International Conference.

Currently, Verabind Tau is offered as a laboratory-developed test (LDT). Veravas is seeking FDA clinical approval based ondatareleased this summer.

To this end, we spoke with Soldo and another co-founder, CEO John Forrest, about the test's significance for early-stage Alzheimer's patients, how it can aid new drug development, and how payers might react to this first-of-its-kind test in a complex field.

This interview has been edited for length and style.

PHARMAVOICE: Where does Verabind Tau fit in the current Alzheimer's testing landscape?

JOHN FORREST:There is a lot of data in the market around the biomarker protein p-tau217, but that marker is typically only easily detectable after symptoms of neurodegeneration appear. Our data shows that we can detect the disease in its early asymptomatic stage, which will be a critical shift. If we can identify it earlier, treatments have the greatest chance of success. We need to change some entrenched notions—distinguishing between "biomarker activity" and "biomarker level"—and that is our core differentiator.

JOSH SOLDO:The FDA-approved or recognized p-tau217 tests orcerebrospinal fluid (CSF) testsare used to diagnose amyloidosis or beta-amyloid plaques, which are highly correlated with the mechanisms of FDA-approved drugs—these are all monoclonal antibody therapies that clear amyloid plaques. But plaques are a risk factor, not the cause of the disease. If the goal is to identify high-risk patients, existing tests are sufficient; but to identify people in the early stages of the disease, you must screen asymptomatic populations. Verabind Tau is a pathology test—it detects the disease itself, not the risk of developing it.

There are already drugs on the market that clear amyloid, but none that clear tau. What is the care pathway for a patient who tests positive with Verabind?

SOLDO:There is indeed no targeted therapy yet, but that doesn't mean the FDA won't approve one tomorrow—especially with more than 20 tau-targeted therapies in various stages of clinical trials. They are coming. For doctors, knowing that a patient has this disease helps with advance planning, proactive intervention, and possibly enrolling patients in clinical trials. Even at the asymptomatic stage, knowing you have a neurological disease is crucial. We can't predict the future, but there are already quite a few promising treatment options being validated.

FORREST:Early identification means having more time to take multiple measures that apply to both amyloid and tau therapies. It's a way to get answers earlier.

Although it's still early, what discussions have you had with pharmaceutical companies regarding drug development collaborations?

FORREST:We've had conversations with several pharmaceutical companies, and the feedback has been positive. They naturally want more validation data, and we are working with some of them to obtain additional samples to demonstrate the test's value. Identifying patients earlier helps advance research.

SOLDO:If our test is used as a tool in the toolkit to enrich patients in the "Goldilocks zone" (i.e., just before symptoms appear) in clinical trials, it can more clearly demonstrate drug efficacy. If trial design is not rigorous, there may be no significant difference between the control and treatment groups. Pharma companies recognize the science; they want more data.

Beyond clinical trials and regulatory approval, the payer environment has been challenging in the Alzheimer's space. How do earlier tests like this factor into that consideration?

FORREST:The long-term goal is to obtain FDA approval and secure Medicare reimbursement coverage. After that, we can consider Medicare Advantage plans, because we can define populations more precisely and think about things differently than before. We can identify risk within specific populations, find out who has the right pathology early on, which helps reduce healthcare costs in multiple ways. If these patients are identified earlier, many preventable expenses can be avoided.

SOLDO:Currently, the test has been validated and is offered as a laboratory-developed test. We are evaluating how to expand its accessibility so that more patients or clinicians who want to use it can access it.