Case study · Diagnostics · oncology biomarker
Finding the fastest legitimate route for a cancer-screening biomarker
A fast-track regulatory plan for the hPg80 biomarker, a Taiwan-first sequence, and clinical collaboration with Chinese oncologists.
What they asked
ECS Progastrin needed to know whether there was real demand for its hPg80 biomarker in cancer screening in China, how long approval would take, and how to build clinical and academic credibility fast enough for commercialisation to be worth planning.
What we did
- Market potential and regulatory timeline research
- Fast-track approval pathway design
- KOL engagement for clinical cooperation and co-publication
- Engagement with the Chinese Society of Clinical Oncology
How it ran
Test the demand before the pathway
We assessed demand for hPg80 in screening high-risk patients — the question that decides whether a regulatory investment is worth making at all.
Design a fast-track route
We mapped the approval options and built a fast-track pathway, identifying Taiwan as the sensible first regulatory step before Mainland China: a shorter cycle that produces evidence and precedent usable in the larger filing.
Recruit the clinical voice
We engaged leading oncologists on clinical cooperation and co-publication with the French team, so that the Chinese evidence base would be built with local authors rather than translated into the market.
Align with the learned society
We opened discussions with CSCO to align on clinical need and possible collaboration, which is where visibility and credibility in Chinese oncology are actually conferred.
Outcome
- Demand for the biomarker in high-risk screening confirmed rather than assumed.
- A fast-track approval plan with a Taiwan-first sequence and dated milestones.
- Named oncologists engaged for clinical studies and co-publication.
- A roadmap to market access that the company could fund and follow.
What it taught us
For a diagnostic, the regulatory route and the academic route are the same route. Approval without Chinese authorship produces a registered product nobody prescribes.
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