CLASS IIb MEDICAL DEVICEFREE ACCESS

Fits your pathway. Changes only the outcome.

Fast, reliable decisions in suspected myocardial infarction – relieving the pressure on your practice and emergency department.

No new device, no additional test. ACS Pathfinder works where ECG and hs-troponin results are already available and estimates the individual probability of acute myocardial infarction – in clinically suspected NSTEMI.

CARE PATHWAY IN SUSPECTED NSTEMI

One extra step – in a familiar place

Step 1

Admission

Age, sex, heart rate, symptom onset ≥ 3 h, smoking status, hyperlipoproteinaemia, family history of CAD

Step 2

12-lead ECG

Signs of ischaemia, yes or no – STEMI ruled out

Step 3

hs-troponin

Single measurement or a second one 30–210 min later; central lab or point-of-care

Step 4 · new

ACS Pathfinder

Individual MI probability in percent, calibrated to the prevalence in your setting

Step 5

Your decision

Outpatient management, observation or further diagnostics – the decision remains clinical

Interpreting the result, as defined in the IFU

Low

< 0.5% (single) · < 1.0% (serial)

Consider alternative diagnoses

Intermediate

up to 50%

Consider further diagnostic evaluation

High

> 50%

Refer to a cardiologist

What goes in

Immediately available routine data only. A super-learner ensemble of gradient boosting (LightGBM), elastic net, logistic regression with splines and MARS estimates the probability; single and serial measurements each use their own model configuration.

01Clinical

AgeSexHeart rateSymptom onset ≥ 3 h

02Risk factors

HyperlipoproteinaemiaSmoking statusFamily history of CAD

03ECG

Signs of ischaemia on the 12-lead resting ECG

04Troponin

hs-cTn at presentation2nd hs-cTn (optional)Time between measurements

11 variables → 1 probability · 0,1 % – 100 %

Supported hs-troponin assays
Manufacturer	Platform	Isoform	Setting
Abbott	Architect	hs-cTnI	Central lab
Beckman Coulter	Access	hs-cTnI	Central lab
Siemens Healthineers	Atellica	hs-cTnI	Central lab
Roche	Elecsys Gen 5	hs-cTnT	Central lab
Siemens Healthineers	Atellica VTLi	hs-cTnI	Point-of-care
PHC / Mitsubishi	Pathfast	hs-cTnI	Point-of-care

Further assays are currently planned. Until then, ACS Pathfinder cannot be used if your assay is not listed.

The evidence

27,674

patients: 2,575 in the development cohort (Germany), more than 25,000 in external validation cohorts

9 / 4

countries on four continents – Germany, Scotland, Sweden, Canada, USA, Australia, New Zealand, Japan, Taiwan

up to 3×

more patients eligible for rapid rule-out than with the current standard, at comparable safety

Publications

Clinical Research in Cardiology · 2023Personalized diagnosis in suspected myocardial infarctionNeumann JT, Twerenbold R, et al. Clin Res Cardiol 2023;112(9):1288–1301Development and validation across six hs-troponin assaysdoi:10.1007/s00392-023-02206-3 →The Lancet Digital Health · 2024Diagnostic accuracy of a machine learning algorithm using point-of-care high-sensitivity cardiac troponin I for rapid rule-out of myocardial infarctionToprak B, Solleder H, et al. Lancet Digit Health 2024;6(10):e729–e738Point-of-care hs-cTnI (Siemens Atellica VTLi)doi:10.1016/S2589-7500(24)00191-2 →

Discrimination by assay (AUC, mean [95% CI])
Assay	Cohorts	n	Single measurement	Serial measurement
hs-cTnI Access	4	5,068	0.95 [0.94–0.96]	0.98 [0.97–0.99]
hs-cTnI Architect	7	11,815	0.92 [0.89–0.94]	0.96 [0.95–0.98]
hs-cTnI Atellica	4	6,222	0.93 [0.90–0.97]	0.96 [0.94–0.98]
hs-cTnI Atellica VTLi (POC)	1	972	0.86 [0.82–0.89]	0.92 [0.90–0.95]
hs-cTnT Elecsys	10	17,484	0.89 [0.87–0.92]	0.94 [0.92–0.96]
hs-cTnI Pathfast (POC)	1	1,177	0.95 [0.94–0.97]	0.98 [0.97–0.99]

Source: Instructions for use 3.0, section 17. Performance may vary in populations that differ significantly from the validation cohorts.

Where it is used

Emergency department

Frees up space and staff resources through earlier, safe identification of patients who can be managed as outpatients.

Emergency medical services

Usable pre-hospital with point-of-care hs-troponin.

Physician's office

A solid basis for the question: refer to hospital or not.

What colleagues ask first

Is ACS Pathfinder approved?

Yes. It is a CE-marked class IIb medical device under Regulation (EU) 2017/745 (notified body 0197). Its intended purpose: an aid in the diagnosis of NSTEMI and in identifying patients who may qualify for outpatient management.

Who may use it?

Qualified healthcare professionals – physicians, nurses and emergency medical services staff – after product-specific training. The in-app tutorial is mandatory and takes about three minutes.

Which patients is it not for?

Contraindicated in suspected STEMI, age < 18 or > 98 years, heart rate < 34/min or > 184/min, and haemodynamic instability.

Which assays are supported?

Abbott Architect, Beckman Coulter Access, Siemens Atellica and Roche Elecsys Gen 5 in the central lab, plus Siemens Atellica VTLi and Pathfast as point-of-care tests. Further assays are planned.

Do I need two troponin values?

No. An estimate is possible from a single measurement. A second value can be added at any time, provided it was sampled 30–210 minutes after the first.

How do I read the result?

As a probability, not a diagnosis. At p = 0.4% and management as "no MI", the probability of error is 0.4%. Always interpret the result in the clinical context and according to applicable guidelines.

What happens to patient data?

Patient data are stored pseudonymised, transmitted encrypted (HTTPS) and processed exclusively on a server in Germany – GDPR-compliant, with no third-party services.

What does access cost?

Access is currently free. Register as an individual user or create an institutional account for your team. The application runs in the browser, with no installation.

Get in touch

Would you like to introduce ACS Pathfinder at your hospital, discuss a research collaboration or ask about the methods? Write to us.

ART-EMIS Hamburg GmbH – a spin-off of University Medical Center Hamburg-Eppendorf and Cardio-CARE AG, founded in 2022.

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