A new-generation diagnostic tool

The nAPCsr test offers clinicians an objective measurement of activated protein C resistance (APCr), a key parameter in oestrogen-induced thrombotic risk.

Results are expressed as a score on a scale from 1 to 10.

When performed prior to or during the prescribing process, the test will enable precise patient stratification:

• women with lower scores may safely continue using standard combined oral contraceptives,
• while higher scores will guide clinicians toward safer alternatives, such as estradiol- or estetrol-based formulations, or even non-oestrogenic strategies.

This approach will significantly reduce the incidence of venous thromboembolic events, provide better-suited treatment options and enhance patient confidence and safety. 

Fully automated examination on ST Genesia

For prescribers, the nAPCsr will be a rapid test, fully automated on the ST Genesia system and clinically validated;

• it will support safer decision-making,
• strengthen informed consent,
• reduce unexpected treatment discontinuations,
• embed patient care within a truly personalised, evidence-based approach to contraceptive medicine.

In practice, automation on ST Genesia will ensure quick, standardised execution, fully compatible with routine hemostasis laboratory workflows.

Collaboration based on clearly defined roles

The collaboration is built on clearly defined roles. 
QUALIblood, responsible for developing, patenting, standardising and validating the biomarker, will naturally lead the R&D activities and clinical studies. 

Stago will handle reagent industrialisation, manage integration of the test into its ST Genesia analyser and assume the role of legal manufacturer. 
Stago will also lead the CE marking process – an essential step for routine laboratory use and commercialisation within the European Union.

Worldwide commercialization

Commercialisation is expected to begin upon completion of the development project, in approximately five years.

It will launch initially in European countries, followed by a gradual roll-out to the rest of the world as regulatory approvals progress.

This initiative places individualised thrombosis risk assessment at the forefront of women’s health, showcasing the synergy between QUALIblood’s scientific and clinical expertise and Stago’s industrial, regulatory and commercial strength.