When a pharma company develops a targeted therapy, they need a diagnostic partner who can find the patients it will help. That partner search is high-stakes, time-pressured, and far more selective than most diagnostics companies realize.
They are looking for a co-developer, not a supplier
This is the central thing to understand. A companion diagnostic has to be developed, validated and approved alongside the drug, and ideally reach market at the same moment. That is not a procurement relationship. It is a coordinated program with linked regulatory timelines and shared risk.
Pharma is therefore not shopping for a test. They are choosing a partner they will be joined to for years, whose failure to deliver on time delays their launch.
What they screen for
- Regulatory track record in co-development. Have you actually taken a companion diagnostic through approval alongside a therapy? This is the single strongest signal, because it is where these partnerships most often break down.
- Platform fit for the biomarker. Tissue-based, sequencing, or liquid biopsy. The biology dictates the platform, and a partner strong in one may be irrelevant for another.
- Validation capability. Can you generate the analytical and clinical evidence regulators will demand?
- Commercial reach. After approval, can the test actually get into clinical practice and get reimbursed? An approved test nobody can order cannot find patients, and pharma has learned this the hard way.
The timing advantage
Because the diagnostic must be ready for the pivotal trial, pharma engages diagnostic partners much earlier in development than outsiders expect. Companies that only become visible when a therapy is approaching approval have already missed the decision.
Being discoverable during a pharma team’s early landscape scan is therefore worth far more than being discoverable later, and it is exactly when most diagnostics companies are quietest.
Be the answer to a specific question
A pharma team scanning this space is asking a narrow question: who can develop a validated companion diagnostic for this biomarker, on this platform, on my timeline? A profile that answers that question directly gets a conversation. One that describes general diagnostics capability does not.
Be the company they find
Pharma teams are scanning for diagnostic partners at the earliest stages of development, long before anyone announces anything. Be visible then.
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Frequently asked questions
How does pharma choose a companion diagnostics partner?
Pharma is choosing a co-developer, not a supplier, since the diagnostic must be developed, validated and approved alongside the drug on linked regulatory timelines. They screen on demonstrated regulatory track record in co-development, platform fit for the specific biomarker, analytical and clinical validation capability, and commercial reach after approval.
When does pharma look for a diagnostic partner?
Much earlier than most diagnostics companies expect, because the test must be ready to select patients for the pivotal trial. Companies that only become visible when a therapy nears approval have already missed the decision, which means being discoverable during a pharma team’s early landscape scan is far more valuable than being visible later.
What makes a diagnostics company attractive to pharma?
A demonstrated history of taking companion diagnostics through approval alongside a therapy, since that is where these partnerships most often break down. Also platform fit for the specific biomarker, the ability to generate the validation evidence regulators demand, and genuine commercial reach so the approved test can actually be ordered and reimbursed.
