Connect The Dots: Precision Testing Leads To Patient Access In Oncology
By Vicky Brown
In pharma, an oncology drug approval is a significant milestone. I have spent enough time in this space to know that it is also the moment where a different, less visible problem begins. The community and industry celebrate approval, and they should. But approval does not put the right medicine in the right patient's hands. In precision oncology, a patient can be sitting with a targetable biomarker, and a medicine is approved for exactly that biomarker, but the patient never receives it.
That gap is quiet. And it costs those living with cancer their best chance at the right treatment. Here is why it happens and what it takes to close the gap.
A First Diagnosis Is Never Complete
Cancer is not one disease. Every person's cancer carries its own biological fingerprint, and the targeted therapies being developed today are designed for specific points on that fingerprint. This means that receiving a cancer diagnosis is only the beginning. The second diagnosis, the biomarker result that tells a patient and their physician which targeted therapy, if any, is matched to their specific cancer cell biology, is just as important as the first. Without it, the picture is incomplete, the diagnosis is incomplete, and the treatment decisions that follow may not be optimal.
For common biomarkers in well-studied cancers, testing has become standard, reflexive. But oncology drug development has moved faster than testing infrastructure. We are now developing therapies for rarer tumor types and populations where biomarkers may only be found in one or two percent of a large patient population. Those patients exist. They are simply not being tested for what they have, because the biomarker is not yet on a standard panel and their oncologist may not be seeing those patients regularly. So, the medicine gets approves for that specific biomarker. The patients remain unidentified. And inside the company, that registers as a slow launch rather than what it is: an access failure hiding in plain sight.
The question this raises for launch teams is not how to generate more demand. It is whether the right patients are being identified.
Rethinking What A Launch Is
Most launch plans are built around a familiar sequence: get approved, build awareness, drive prescriptions. In precision oncology, that sequence breaks down. If no one is testing for the biomarker your therapy targets, awareness of the therapy is beside the point. Patient identification has to come first, and that means working with pathologists to get the biomarker onto testing panels, partnering with diagnostic companies who build those panels, and doing all of it before the product arrives, not after.
This is a fundamental shift in how commercial teams need to think about their job. The goal is not brand choice. It is patient identification. And patient identification requires a different set of relationships, built much earlier, with a much wider group of stakeholders than a traditional launch infrastructure touches.
Getting all of those stakeholders pulling in the same direction is where the real work begins.
One Team, Built Before Launch
Across all of these stakeholders, the shared goal is the same: patients on the right therapies, as quickly as possible. But achieving that requires mapping the entire journey from diagnosis to treatment, understanding where the barriers sit, and getting ahead of them. That means appropriately bringing pathologists, diagnostic companies, advocacy organizations, oncologists, and payers into the same conversation, not considering them independently and hoping the pieces connect.
When they are in the room together, something shifts. A pathologist who understands that a new actionable biomarker exists is more likely to include it in a panel. An advocacy partner who understands the importance of complete diagnosis can tell patients to ask for their biomarker results before starting treatment. A payer who understands that a well-matched therapy leads to better outcomes is more likely to support access. The gaps close faster when everyone can see the part they play in the whole journey rather than just their own piece of it.
Which brings us to the patient, who has more power to close the gap than many commercial strategies acknowledge.
The Most Underused Lever In Precision Oncology
We understand the urgency a patient feels at diagnosis. The instinct is to start treatment immediately. What patients need to know is that pausing long enough to get biomarker results does not slow their care down. It directs it. A patient who knows to ask the right questions before starting treatment is far more likely to receive a targeted therapy matched to their specific cancer biology. This approach is powerful, and creating awareness with patients is part of the diagnosis and access infrastructure, not a downstream communications exercise.
It means showing up wherever patients go when they are processing a cancer diagnosis: their physician's office, their advocacy organization, the search results they find at midnight. It means making sure that wherever they land, the information is there and consistent. Caregivers are often doing this searching first, so they need to be reached too. The surround sound matters because patients do not follow a single path, and neither should the information.
All of this — the stakeholder alignment, the diagnostic infrastructure, the patient empowerment — only sticks if companies are willing to measure the right things.
Measuring What The Science Demands
The metrics that have historically defined a successful launch, such as brand share, net sales, and prescription volume, sit downstream of the problem I am describing. They tell you what happened after a patient was identified. They do not tell you how many patients were never identified at all.
In precision oncology, the leading indicators have to be testing rates and treatment rates among biomarker-positive patients. Is the biomarker being tested for? Are patients who have the biomarker receiving the matched targeted therapy? If those numbers are moving, the commercial results will follow. If they are not, no amount of brand awareness spending will fix it.
This also means building commercial teams differently. Sales teams drive brand choice and demand. But in precision oncology, you also need infrastructure and people focused specifically on patient identification, on working with pathologists, on ensuring the biomarker is on the right panels, on connecting the diagnostic pathway to the treatment pathway. That is not a supporting function. It is the core of the launch.
The gap between approval and patient access does not close because a medicine exists. It closes because a company builds the ecosystem to make the match happen. That is the work. And it has to start well before the approval that everyone celebrates.
About The Author:
Vicky Brown is SVP, US Head of Oncology at Boehringer Ingelheim.