Our Scientific Approach

At Orca Dx, we are redefining how the menopause transition is detected and understood. Traditional diagnostic tools rely primarily on symptoms and hormonal snapshots, which often lead to inconsistent or inconclusive results. This is especially true during perimenopause, when hormone levels can vary significantly from day to day and symptoms overlap with other clinical indications.
Orca takes a fundamentally different approach.

Orca’s diagnostic platform focuses on identifying early biological signals that indicate the onset of the menopause transition. Rather than relying on subjective symptom reporting or hormone levels—both of which can fluctuate daily—we target more stable, non-hormonal changes.
By combining physiological data with clinical and demographic information, we aim to develop a single-point test that detects early perimenopausal biomarkers—often before symptoms are clearly recognized. This enables more accurate, reliable, and actionable results.

Orca is developing supervised machine learning models to classify users as pre-, peri-, or postmenopausal. These models are trained and tested on de-identified medical datasets that include diverse populations with varying ages, symptoms, and hormone health backgrounds.
Our focus is on building high-accuracy models that align with known molecular pathways and identify meaningful patterns across biological and demographic inputs. The system is designed to evolve with new data, improving performance over time as additional training sets become available. This work is ongoing, and our team continues to refine model architecture, feature selection, and data inputs as part of the early research and development phase.

Orca’s platform connects a simple physical sample, such as urine or saliva, with a user-friendly mobile app. The app delivers personalized results, educational content, and actionable insights.
By testing annually, women can track their health status over time, while the platform’s predictive accuracy improves as it learns from longitudinal data.
This approach brings together rigorous science and real-world usability. Orca makes high-quality diagnostics accessible at home, removing the barriers of traditional lab-based methods.

Orca Dx is backed by a network of experienced advisors with deep expertise in regulatory affairs, commercialization, medical devices, and AI-driven diagnostics. Their guidance shapes our development strategy and ensures that our work is grounded in both scientific rigor and real-world applicability.

Our advisory team includes leaders in:

• Regulatory strategy and compliance for medtech
• Commercialization of healthtech and AI innovations
• Clinical translation and validation of diagnostics
• Medical device development
• Machine learning and data science in healthcare
  

Their guidance ensures our platform is not only innovative but also scalable, ethical, and clinically meaningful.