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Accepted into FDA’s ISTAND qualification pathway

Accepted into FDA’s ISTAND qualification pathway

Introducing Absentia’s AI Predictive Drug-Induced Cardiotoxicity Module

Absentia combines patient outcome data with preclinical mechanistic readouts to surface cardiotoxicity risk earlier—giving scientists quantitative risk, mechanistic context, and weight-of-evidence support for IND and drug development decisions.

Module

Digital Cardiac Model

Status

Accepted into FDA’s ISTAND qualification pathway

Inputs

Patient outcome data, preclinical mechanistic readouts

Outputs

Quantitative risk, mechanistic context, weight-of-evidence support

The problem

The problem

The problem

See cardiac risk before it becomes a late-stage surprise.

Cardiotoxicity can become visible when the options for addressing it are already narrowing. Absentia is designed to surface potential risk earlier—while teams still have room to act.

~25%

~25%

~25%

of small molecules that fail in clinical development due to toxicity are attributed to cardiotoxicity.

Mechanism

Mechanism

Mechanism

Cardiac safety goes beyond a single endpoint.

hERG screening remains an important checkpoint for electrophysiological risk. But drug-induced cardiotoxicity can also emerge through structural and functional/hemodynamic failure modes. Absentia is designed to bring these signals together within one predictive framework.

Failure mode

hERG screening

hERG

Absentia cardiac model

Absentia

Electrophysiological

Evaluate signals related to cardiac electrophysiology.

Structural

Predict morphological cardiac liabilities.

Functional / Hemodynamic

Add context around functional and hemodynamic risk.

hERG remains a valuable checkpoint. The cardiac model is designed to evaluate the broader mechanistic picture alongside it.

Platform

Platform

Platform

FDA ISTAND acceptance is the latest step in Absentia’s predictive safety platform.

Following its Digital Liver milestone, Absentia’s AI-driven Digital Cardiac Model has also been accepted into FDA’s ISTAND qualification pathway—advancing a more complete approach to evaluating one of drug development’s most common toxicity risks.

01 Established

Liver

Digital Liver, the first organ-system proof point in the platform.

02 Now

Cardiac

The AI-driven Digital Cardiac Model, accepted into FDA’s ISTAND qualification pathway.

03 Output

Multi-organ safety

A broader predictive safety platform across organ systems.

Contact us

Contact us

Contact us

Interested in evaluating Absentia’s cardiac safety capabilities?

Whether you’re evaluating a compound, exploring a scientific collaboration, or looking at new approaches to predictive safety, we’d be glad to talk.

Primary contact

Jeff Marblestone

Head of Strategic Partnerships & BD

© 2026 Absentia Labs, Inc.
All rights reserved.

Absentia Labs™ is a trademark of Absentia Labs, Inc.

© 2026 Absentia Labs, Inc.
All rights reserved.

Absentia Labs™ is a trademark of Absentia Labs, Inc.

© 2026 Absentia Labs, Inc.
All rights reserved.

Absentia Labs™ is a trademark of Absentia Labs, Inc.