Clinical trial acceleration

Accelerate clinical trials with AI screening

In biomarker-driven trials, most molecular tests come back negative. Waiv’s AI reads the H&E slide and flags the patients most likely to qualify, so only they go on to confirmatory testing.

A gloved hand holding a stained H&E glass slide in the lab

How AI screening works

1
2
3
Whole population
40
patients screened

Every routine H&E slide is scanned

The diagnostic slides you already have. No extra tissue is used.

High likelihood
15
flagged by AI

AI flags high-likelihood patients

Waiv’s model predicts the biomarker from each slide. Only these patients go on to testing.

Confirmed positive
5
confirmed positive of 15 tested

Confirmatory testing finds the positives

Fewer negative molecular tests, less tissue and budget spent, faster enrollment.

Patient
High likelihood (AI)
Confirmed positive
Tested negative
Illustrative cohort, not study data
 

Cut diagnostic testing costs

Rule out unlikely candidates before confirmatory testing

Our AI screens patients directly from routine H&E slides and identifies those unlikely to carry the biomarker. Confirmatory tests go to the most likely candidates to decide eligibility.

Spend less to find each eligible patient

When most tests come back negative, every eligible patient is expensive to find. AI-powered screening focuses confirmatory testing on likely positives, so you spend less to enroll each one.

More lab capacity, less tissue used

Fewer unnecessary tests means more lab capacity and more tissue preserved, which is especially valuable in indications where tissue is scarce.

AI biomarker score rule-out threshold 0 1 0.08 Unlikely carrier · confirmatory test not needed
 
Patient recruitment

Accelerate patient recruitment

A screening result within minutes of digitizing the slide

Our AI delivers a clear call on whether confirmatory testing is recommended, a biomarker likelihood score, and the slide areas that drove the prediction. Sites know who to send for confirmatory testing without waiting.

Shorten your enrollment period

By prioritizing likely-positive patients, screening identifies the patients your trial needs with fewer tests, so enrollment completes sooner.

Reduce your trial’s daily burn rate

A Phase 3 trial costs around $55,000 a day to run. Every day of enrollment saved goes straight back to your budget.

A pathologist reviewing a scanned H&E slide and its AI report on a monitor
Screening result
Within minutes
Confirmatory testing recommended
Biomarker likelihood
High
 
Regions driving the call
Enrollment period
Standard screening
 
With Waiv AI screening
 
Illustrative
Cost of every trial day
~$55,000
a day to run a Phase 3 trial
 
A close-up 3D render of a therapeutic protein molecule
Launch date
Standard screening
 
With Waiv AI screening
 
Illustrative
Race to market
Your program
Ahead
 
Competitor A
 
Competitor B
 
Illustrative
Lifetime revenue
Standard launch
 
Earlier launch with Waiv AI screening
 
Illustrative
Path to market

Fast-track your drug’s path to market

Every day saved in enrollment brings your launch closer

Faster enrollment shortens the whole trial and brings your launch date forward.

Get ahead of competitors

Arriving earlier strengthens your position against competitors in the same indication.

Start generating revenue sooner

Launching earlier increases the value of your drug’s revenue over its lifetime, even after accounting for patent and exclusivity effects.

How it works

From slide to screening result in minutes

Waiv screening fits into the workflow your sites already run. Nothing changes at diagnosis, and only likely-positive patients move on to molecular testing.

At diagnosis
Use the slide you already have

The routine H&E slide prepared at diagnosis. No extra tissue or new stain required.

Pathology lab
Digitize

The slide is scanned directly at the pathology lab, or at a central lab.

Waiv AI
AI screening

Our AI biomarker test, powered by robust H&E foundation models, predicts status within minutes.

Before inclusion
Refer for confirmation

Likely-positive patients go on to confirmatory testing before trial inclusion.

Fewer negative molecular tests, less tissue and budget spent, and faster enrollment.

Work with us
Why Waiv

Built on clinical-grade AI

Clinical-grade experience

We have taken AI pathology tests from development through CE-IVDR certification and into routine clinical use.

Validated at scale

Our tests are validated in large, multi-center clinical studies across Europe and the US.

Seven years of AI pathology research

More than 66 publications, built on data from over 80 academic institutions representing more than 600 hospitals and labs.

7
years of research
66+
publications
80+
academic institutions
600+
hospitals and labs
Fast, tissue-sparing, reproducible

Results in minutes from the existing H&E slide, with no tissue consumed and consistent results every time.

From screening tool to companion diagnostic

The AI that screens your trial patients can be developed into a CDx or IVD for use after approval.

The assay that screens your patients can become your companion diagnostic.
Contact usSee how we take it from trial to approval →