Precision Medicine Breakthroughs: Making Personalized Cancer Treatment Accessible | LeverVenture Impact Stories
The binding constraint on precision oncology isn't the drugs — it's the biomarker test that has to happen first, and often doesn't in time.
By Peleg Chevion, Managing Partner
7 min read · Life Sciences and Healthcare
In this note07 · 7 min
A targeted cancer therapy that never reaches an eligible patient produces no clinical benefit and no revenue, regardless of how strong its trial data was. The constraint on precision oncology's real-world impact is rarely the therapy itself. It is the diagnostic step that has to happen before anyone can know the therapy applies: a biomarker test has to be ordered, the right specimen has to be collected and sent, the result has to come back in time to inform a treatment decision, and a clinician has to act on it. Each of those steps can fail independently, and in oncology today, they frequently do.
This is a clinical-access argument, not a drug-development one. The molecular biology behind modern targeted and immuno-oncology agents has advanced faster than the testing infrastructure required to identify who should receive them. That gap — not a shortage of good drugs — is the binding constraint on how many patients actually benefit from precision oncology at present, and it is a gap growth equity capital can meaningfully close.
01Companion Diagnostics Are Necessary, Not Sufficient
A companion diagnostic being approved and available does not mean it is being ordered, performed correctly, and acted on for every eligible patient. Ordering the test is a clinical workflow decision, made under time pressure, sometimes without a clear standard forcing it. Even where guidelines clearly recommend a biomarker panel before initiating first-line treatment, real-world testing behavior varies considerably by practice setting, tumor type, and the specific logistics of specimen handling. Approval creates the possibility of precision treatment. It does not create the workflow that reliably delivers it.
The gap widens further at the specimen level. A biopsy adequate for a routine histology read is not always adequate for a comprehensive molecular panel, and a patient whose only available tissue is a small needle biopsy may simply not have enough material to test for every relevant biomarker. When that happens, the clinical team faces a choice between a second, more invasive biopsy purely to obtain testing material, a liquid biopsy that may or may not capture the relevant mutation, or proceeding to treatment without a complete molecular picture. Each of those choices carries a cost in time, risk, or completeness that a company selling only the test itself does not have to absorb, but the patient does.
02The Community-Academic Gap Is Real and Persistent
Most cancer care in the United States is delivered in community oncology settings, not academic medical centers, and that is precisely where biomarker testing infrastructure tends to be thinnest. Community practices often lack in-house molecular pathology, send specimens to outside reference laboratories, and operate without the dedicated genomics tumor boards that academic centers use to interpret ambiguous results. Published research on lung cancer testing behavior has consistently found meaningful differences between how community and academic oncologists approach biomarker testing — not necessarily in whether a test gets ordered, but in how consistently the result is obtained in time and how confidently it is used to guide the treatment conversation with the patient. Academic centers are also more likely to have a molecular tumor board on hand to interpret an ambiguous or variant-of-uncertain-significance result, a resource most community practices simply do not have in-house and must access, if at all, through a referral or a remote consultation that adds its own delay.
None of this reflects a lack of clinical skill in community settings, where the great majority of oncology care actually happens. It reflects an infrastructure gap: academic centers were early adopters of in-house molecular pathology and dedicated genomics staffing because they had the case volume and research funding to justify building it. Most community practices were never handed a version of that infrastructure sized to their own volume, and the commercial reference laboratories that fill the gap add a shipping and processing step that academic in-house testing does not require.
03Turnaround Time Is a Clinical Variable
A biomarker result that arrives after a clinician has already started first-line treatment is functionally the same as no result at all for that treatment decision. Turnaround time for next-generation sequencing-based panels routinely stretches into weeks when specimens are sent to outside reference laboratories, and a meaningful share of patients begin treatment before comprehensive results return — particularly in fast-moving or symptomatic cancers where waiting is not always clinically acceptable. This is not a data quality problem. It is a logistics and infrastructure problem, and it is one of the more tractable ones in the entire precision oncology pipeline.
A perfect drug matched to the wrong number of patients because the test never came back in time is not a clinical success story. It is a diagnostic failure wearing a therapeutic label.
04Where the Bottleneck Actually Breaks
The single highest-leverage fix in this chain is reflex testing: automatically ordering the relevant biomarker panel at the moment of diagnosis, built into the pathology workflow, rather than leaving the order to a subsequent, separate clinical decision by an oncologist under time pressure. Reflex testing removes an entire decision point from the chain and has been associated with meaningfully higher completion rates wherever health systems have implemented it consistently. It is also one of the more investable interventions in this space, because it is an operational and workflow fix rather than a novel scientific one — the kind of problem growth-stage companies building diagnostics infrastructure and laboratory workflow software are well positioned to solve.
05The Chain and Where It Breaks
| Step | Where it commonly fails | What closes the gap |
|---|---|---|
| Test ordered | Left to individual clinician discretion, not automatic | Reflex testing built into the pathology workflow |
| Specimen adequacy | Insufficient tissue for a full panel, especially on small biopsies | Standardized specimen collection protocols |
| Turnaround time | Outside reference lab dependency, multi-week delays | In-network or faster-cycle testing infrastructure |
| Result acted on | Clinician proceeds with treatment before results return | Workflow holds or alerts tied to pending results |
06What This Means for Diligence
Growth equity investors evaluating a precision oncology company — whether it is a therapeutics developer or an adjacent diagnostics or workflow business — should ask a narrower and more useful question than "how large is the addressable patient population." Ask instead what share of that population is actually being tested, in what setting, with what turnaround time, and what happens to the ones who are not. A therapeutics company's real addressable market is not the epidemiological population with the relevant mutation; it is the subset of that population whose biomarker status a clinician will actually know in time to act on it. For the broader question of where value accrues across the diagnostics and therapeutics stack, see our note on the precision medicine investment landscape, and for how commercial access challenges persist even after a therapy is approved, see gene therapy commercial viability.
07Frequently asked questions
Why don't more cancer patients get precision medicine treatments even when the right drugs exist?
The bottleneck is usually diagnostic, not therapeutic. A biomarker test has to be ordered, the right specimen collected, results returned in time, and a clinician has to act on them—and each step can fail independently. Most U.S. cancer care happens in community oncology settings, which often lack in-house molecular pathology, so testing infrastructure lags behind drug development.
What is a companion diagnostic, and why isn't its approval enough on its own?
A companion diagnostic identifies which patients a targeted therapy will work for. Approval only makes the test available—it doesn't guarantee it is ordered, performed correctly, or acted on for every eligible patient, because ordering it is a clinical workflow decision made under time pressure, sometimes without a clear standard forcing it.
Why is biomarker testing less consistent in community cancer clinics than in academic centers?
Most U.S. cancer care happens in community oncology settings, which typically lack in-house molecular pathology and send specimens to outside reference laboratories, without the dedicated genomics tumor boards academic centers use to interpret ambiguous results. This reflects an infrastructure gap tied to case volume and research funding history, not a difference in clinical skill.
How long does biomarker test turnaround take, and why does it matter?
Turnaround for next-generation sequencing panels sent to outside reference laboratories routinely stretches into weeks. A meaningful share of patients begin first-line treatment before comprehensive results return, particularly in fast-moving cancers—making a late result functionally the same as no result for that treatment decision.
What is reflex testing, and why is it considered the highest-leverage fix?
Reflex testing automatically orders the relevant biomarker panel at the moment of diagnosis, built into the pathology workflow, instead of leaving the order to a separate clinical decision made later by an oncologist under time pressure. It removes an entire decision point from the chain and has been linked to meaningfully higher testing completion rates.
What should investors evaluating a precision oncology company ask instead of just market size?
Ask what share of the addressable population is actually tested, in what setting, with what turnaround time, and what happens to the patients who are not tested. A therapy's real addressable market is the subset of patients whose biomarker status a clinician will know in time to act on—not the full epidemiological population carrying the mutation.
Nothing in this piece is investment, legal, tax or accounting advice, and nothing in it is an offer to sell or a solicitation of an offer to buy any security.
Three decades of operational leadership across agriculture, pharmaceuticals, biotechnology, climate, food and defense. He has spent that career doing the work this seat requires: strategic partnerships, licensing and business development, executed transaction by transaction. He sits with a company as an operating partner and a growth strategist rather than as a name on its board. A corporate finance and intellectual property attorney, an INSEAD MBA, and a former Air Force officer in aerospace. He also brings strong private equity experience.