Project Brief

A digital pathology company specializing in AI-driven automated biomarker quantification is looking to validate their technology and business in Southeast Asia. Its flagship solution provides cell-level, quantitative biomarker analysis directly from whole-slide images. It is designed to detect a broad panel of clinically significant biomarkers for various cancers, with an initial prioritization of breast cancer markers, including: ER, PR, HER2 and Ki-67. 

These biomarkers are crucial for classifying breast cancer into molecular subtypes, guiding prognosis, and personalizing treatment by identifying hormone receptor status (ER/PR), HER2 amplification, and cell proliferation rate (Ki-67). These markers help doctors decide if a patient needs hormone therapy (for ER/PR+), targeted therapy (for HER2+), or chemotherapy, and predict how aggressive the cancer might be. 

Key features of this technology include:

1. Scoring optimized for low-level IHC expression

2. Whole-slide analysis scanning over 3 million cells at once

3. Reduction of interoperator variability

4. Summarized reports

5. Identifying patients for ADC drug therapies

Project Overview

This project aims to evaluate the clinical relevance, usability, and market fit of the biomarker quantification AI for medical use in Southeast Asia. The study will explore how experts currently approach cancer scoring and biomarker expression quantification, specifically in breast cancer, identify key pain points, and assess how this new tech could improve clinical workflows, speed, and coverage.

Advisors Needed

Experience:  Minimum 10 years’ total experience in their respective domain   

• Oncopathologist or Oncologist: Pathologists who routinely use IHC testing and/or utilize digital pathology

• Industry  Experts: Professionals with experience in sales, business development, or marketing at global or mid-to-large digital pathology or pharmaceutical companies in the oncology sector

• Regulatory Expert: Professionals well-versed in regulatory approvals for Southeast Asian countries under the ASEAN Medical Device Directive (AMDD), with expertise in IVD and SaMD

Geographical Focus Key Regions: Southeast Asia

Work Required: Advisors will be provided with a detailed background document on the company and its flagship product, including its features, benefits, and the company’s vision for a new orthodontic treatment journey.

Survey Completion: Experts will provide detailed feedback through a survey consisting of approximately 30 multiple-choice and open-ended questions focused on market potential, usability, and clinical impact.

Estimated Time Commitment: ~1 hour

The honorarium provided shall be subject to the qualifications, relevance, and experience level of the applicant.