Progress in validating in-home blood test, combined with cognitive assessment and specialty virtual care, break through barriers to early detection
Key Takeaways
- Findings from breakthrough approach to early detection for Alzheimer’s disease (AD) has the potential to reduce time from earliest development of symptoms to care by 4.5 years are presented at the AAIC 2025.
- Results show strong correlation between TASSO vs. traditional phlebotomist blood draw/capillary collection with the potential to successfully triage patients.
- New ecosystem brings together in-home biomarker testing and a cognitive assessment with virtual care to reduce multiple barriers to the early detection and treatment of Alzheimer’s disease.
- Neurogen’s online platform offering in-home blood testing for Alzheimer’s disease for people with memory concerns is in beta test and readies for national launch – offers a potential solution to meet the urgent global demand for faster adoption and equitable access to breakthrough testing technologies for early detection of AD.
CHICAGO, July 28, 2025 (GLOBE NEWSWIRE) — Advancements in accelerating early Alzheimer’s disease screening and access to care proven from three diverse community pilot initiatives were presented today during a podium presentation at the Alzheimer’s Association International Conference® 2025 (AAIC). The study entitled, “Remote Collection of Biomarkers for Alzheimer’s Disease and Related Disorders” was designed to validate Neurogen’s new ecosystem that brings together the first in-home biomarker testing and a cognitive assessment with virtual care. Study findings suggest that the ecosystem has the potential to reduce the time from earliest development of symptoms to care by 4.5 years breaking down multiple barriers to early detection and treatment of Alzheimer’s disease. The study also validated a strong correlation between TASSO vs. traditional phlebotomist blood draw/capillary collection suggesting TASSO’s potential to successfully triage patients.
“We created a new model to reach those with Mild Cognitive Impairment (MCI),” said Elisabeth Thijssen, PhD, Chief Scientific Officer, Neurogen Biomarking and the session presenter whose research focus for nearly a decade has been on blood-based biomarkers for AD and specifically P-tau217. “Neurogen’s ecosystem is built to meet the urgent global demand for faster adoption of breakthrough testing technologies for early detection of AD. Our mission is to give everyone equal access to cutting-edge technology to detect Alzheimer’s early—when treatment can make the greatest impact on the course of people’s lives.”
The findings come from three free community events targeting people aged 50 years and older held at local hospitals in Chicago, Illinois; Flint, Michigan; and Coldwater, Michigan to sign up participants. Participants were recruited through community engagement, traditional and social media and mobilization of communications targeting area health and wellness organizations.
About the Screenings
- Event participants began the screening with an advanced digital cognitive assessment and a brief lifestyle survey.
- Every participant did the traditional IV venous blood draw performed by a licensed professional. The TASSO, non-invasive method that allows for blood collection without the need for a needle was offered and optional.
- All samples were preserved through ambient shipment, maintaining integrity without the need for refrigeration or freezing.
- IV samples were analyzed using the ALZpath P-tau217 assay, a validated ultrasensitive biomarker test that closely correlates with Alzheimer’s pathology.
- Testing was conducted in CLIA- and CAP-certified laboratories, ensuring clinical accuracy and regulatory compliance with results within days and a follow up via telehealth counseling with a board-certified neurologist if needed.
Study Results
- A total of 455 participants received biomarker and digital cognitive testing:
- 66% were Women
- Average age was 67
- 45% were White/Caucasian
- 39% were Black/African American
- 16% did not report
- Among the 455 test participants, 26 percent had elevated P-tau217 concentrations
- Eighty percent had some form of cognitive impairment as is typical in this kind of event
- TASSO could identify elevated P-tau217 with 88% accuracy and meets the performance requirement for AD triaging in a broader population.
- Participants with elevated test results received follow up care via telehealth from board certified neurologists within days.
- The Neurogen ecosystem reduced the time from cognitive concerns to intervention by 4.5 years—changing the standard time from the emergence of cognitive concerns from years (3 to 6 years) to months (4 months to 1.5 years).
“In one-day events held in three different U.S. communities reaching people with no prior dementia diagnosis, we found 18 percent tested positive for P-tau217 and an additional eight percent were intermediate,” Dr. Thijssen stated. “Bringing these people immediately into virtual care with a neurologist who shared the test results and provided a personalized brain health action care plan was heartening given the long wait time to see a specialist once a patient expresses memory concerns to their primary care physicians that is now typical in the US.”
Neurogen’s online ecosystem offers in-home testing for Alzheimer’s disease for people with memory concerns and virtual follow up care with board-certified neurologists. It is now in beta test and readies for national launch.
The Unmet Need: Access to Early Detection Testing for Alzheimer’s
An estimated 40% of Americans aged 65 and older—representing more than 16 million people—experience some form of memory impairment¹. Yet, fewer than 8% of older adults living with Mild Cognitive Impairment (MCI) ever receive a formal diagnosis, leaving 92% without answers or access to early intervention². On average, there is a staggering 6- to 8-year delay from the onset of symptoms to diagnosis—even though today’s treatments are most effective when administered in the earliest stages of disease3. Further compounding the issue, fewer than one in five Alzheimer’s diagnoses in the U.S. currently involve biomarker testing, due in large part to gaps in accessibility and clinical expertise³. These data underscore an urgent call to transform how Alzheimer’s and cognitive decline are detected and managed—especially as the aging population grows and new diagnostic tools become available.
About Neurogen
Neurogen Biomarking is on a global mission to give everyone equitable access to brain health care. The company offers the first at-home blood biomarker test for phosphorylated (P-tau217) using proprietary blood collection technology and advanced digital cognitive testing with results guided by board-certified neurologists via telehealth. Neurogen’s vision is to deliver accessible technology, actionable insights, and pathways to precision-based proactive care to support early detection and care for Mild Cognitive Impairment (MCI) and dementia associated with Alzheimer’s disease (AD). Neurogen was founded by award-winning neurologist Dr. Rany Aburashed and developed with co-founders Elisabeth Thijssen, PhD, Chief Scientific Officer, and Ken Bahk, Chief Strategy Officer. The company is guided by a team of world-renowned brain health experts www.neurogenbiomarking.com.
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Citations
- Small, G.W. (2002). What we need to know about age-related memory loss. BMJ, 324(7352), 1502–1505. https://doi.org/10.1136/bmj.324.7352.1502
- Liu, J. L., Hlavka, J. P., Coulter, D., Baxi, S. M., & Mattke, S. (2023).
Barriers to the Use of Alzheimer’s Disease Biomarkers in Clinical Practice. Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring, 15(1), e12417.
https://doi.org/10.1002/dad2.12417 - Alzheimer’s Association. (2023). 2023 Alzheimer’s Disease Facts and Figures. Alzheimer’s & Dementia, 19(3), 159–258. https://doi.org/10.1002/alz.13016
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cf44512c-4bea-4251-a912-6638686682c9