TauTRACE

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Biocensor technology

TauTRACE

Faster blood-based Alzheimer’s biomarker screening for clinical triage

Dual-biomarker electrochemical sensor for p-tau217 (Core 1) and MTBR-tau243 (Core 2) from a single plasma sample — built for faster AD biomarker detection and referral decisions in under 30 minutes.

<$100 target cost per test

<30 min sample to answer

2-in-1 T1 + T2 staging

Single plasma sample · Dual independently functionalized electrodes · Quantum-capacitance readout

The Problem

The Problem

Diagnosis is still expensive, invasive, or incomplete.

Diagnosis is still expensive, invasive, or incomplete.

Roughly 7 million Americans currently live with Alzheimer’s, a number expected to approach 13 million by 2050. Diagnosis still leans on amyloid PET imaging (~$4,637, radiotracer-dependent, limited access) or invasive lumbar puncture for CSF biomarkers. Even the first FDA-cleared blood test only answers whether amyloid is present — not whether tau pathology has progressed to the tangle stage, which is what actually determines treatment urgency and eligibility for anti-amyloid therapy.

Roughly 7 million Americans currently live with Alzheimer’s, a number expected to approach 13 million by 2050. Diagnosis still leans on amyloid PET imaging (~$4,637, radiotracer-dependent, limited access) or invasive lumbar puncture for CSF biomarkers. Even the first FDA-cleared blood test only answers whether amyloid is present — not whether tau pathology has progressed to the tangle stage, which is what actually determines treatment urgency and eligibility for anti-amyloid therapy.

Our Approach

Our Approach

Two-stage biological staging, implemented directly in hardware.

Two-stage biological staging, implemented directly in hardware.

TauTRACE is the first electrochemical platform to implement the NIA-AA two-step biological staging model directly in hardware — one disposable sensor, two independently functionalized electrodes, one plasma sample. Detection is label-free: target binding to a covalently anchored redox-active sensing layer produces a measurable quantum-capacitance change — no secondary antibodies, enzymatic amplification, or central lab.

TauTRACE is the first electrochemical platform to implement the NIA-AA two-step biological staging model directly in hardware — one disposable sensor, two independently functionalized electrodes, one plasma sample. Detection is label-free: target binding to a covalently anchored redox-active sensing layer produces a measurable quantum-capacitance change — no secondary antibodies, enzymatic amplification, or central lab.

Core 1 channel

Core 1 channel

Screens for p-tau217, the earliest and most sensitive amyloid pathology marker.

Screens for p-tau217, the earliest and most sensitive amyloid pathology marker.

Core 2 channel

Core 2 channel

Detects MTBR-tau243, a later marker that tracks tau-tangle accumulation and cognitive decline more closely than amyloid burden.

Detects MTBR-tau243, a later marker that tracks tau-tangle accumulation and cognitive decline more closely than amyloid burden.

Label-free readout

Label-free readout

Target binding produces a measurable quantum-capacitance change — no secondary antibodies, enzymatic amplification, or central lab.

Target binding produces a measurable quantum-capacitance change — no secondary antibodies, enzymatic amplification, or central lab.

Cost vs. Standard of Care

Designed around
point-of-care economics.

Method

Method

Type

Type

Cost

Cost

Amyloid PET scan

Amyloid PET scan

Imaging

Imaging

~$4,637

~$4,637

CSF biomarker panel

CSF biomarker panel

Invasive

Invasive

~$260+

~$260+

PrecivityAD2

PrecivityAD2

Blood (C2N)

Blood (C2N)

$1,450

$1,450

Lucent/Labcorp pTau217

Lucent/Labcorp pTau217

Blood

Blood

$300

$300

Reference only — Fujirebio Lumipulse component kit pricing (lab input cost, not a per-patient test price)

Reference only — Fujirebio Lumipulse component kit pricing (lab input cost, not a per-patient test price)

Lumipulse pTau217 IRC Kit (Fujirebio)

Lumipulse pTau217 IRC Kit (Fujirebio)

Blood, CSF assay

Blood, CSF assay

$2,100.00

$2,100.00

Lumipulse pTau217 Calibrator Kit (Fujirebio)

Lumipulse pTau217 Calibrator Kit (Fujirebio)

Blood, CSF assay

Blood, CSF assay

$880.00

$880.00

TauTRACE (target)

TauTRACE (target)

Blood, dual-stage

Blood, dual-stage

<$100

<$100

Why Now

Treatment access now depends on biomarker-confirmed staging.

Anti-amyloid therapies (lecanemab, donanemab) are approved and require biomarker-confirmed eligibility. CMS has already established a billing pathway for blood-based AD biomarkers (PLA code 0358U). The market wants a test that goes beyond ruling amyloid in or out — one that tells a physician how far the disease has progressed, in a single low-cost, point-of-care format.

How the Screen Guides Next Steps

One sample, two biological channels, one triage answer.

01

Single Plasma Sample

Start with one blood plasma draw.

02

Core 1 Channel

p-tau217, earliest amyloid signal.

03

Core 2 Channel

MTBR-tau243, tangle-stage marker.

04

Combined Result

Clinical triage guidance in under 30 minutes.


AD Staging Results: Core 1/Core 2 Classification

AD Staging Results: Core 1/Core 2 Classification

Healthy

Core 1 negative — no further testing indicated.

Core 1 negative — no further testing indicated.

MCI / Early Stage

Core 1 positive, Core 2 negative — amyloid pathology, pre-tangle.

Core 1 positive, Core 2 negative — amyloid pathology, pre-tangle.

AD / Tangle-Stage

Core 1 + Core 2 positive — confirmed tau tangle progression.

Core 1 + Core 2 positive — confirmed tau tangle progression.

Agilus Neuro

Agilus Neuro

Biosensor platforms for biomarker detection, spun out of Washington University in St. Louis.

info@agilusneuro.com