by Laura Farmer & Christian Hayden, Opus Strategy

More than one in eight patients with advanced NSCLC is being systematically deprived of effective targeted therapy, despite having treatable, guideline-recommended biomarkers. That gap doesn’t reflect a shortage of targeted therapies. It reflects a failure of the testing that determines access to them.

A recent JCO Oncology Practice commentary by Voruganti et al. (“Illusion of Comprehensive Testing in Non–Small Cell Lung Cancer”) documents the scope of that problem in detail. The short version: assays marketed as comprehensive vary meaningfully in gene coverage, RNA fusion detection, sensitivity for low-frequency alterations, and reporting clarity. A negative result may reflect assay limitation rather than true absence of an actionable alteration.

For pharma and biotech companies developing precision oncology programs, this is a strategic issue as much as a clinical one. Targeted therapies only work at scale if the right patients are identified. Three areas warrant particular attention.

First, companion diagnostic strategy needs to account for RNA. DNA-based panels alone systematically under-detect fusions and splice variants (MET exon 14 skipping being one prominent example). Companies developing fusion-targeting agents or splice variant-dependent therapies should be building RNA-inclusive CDx requirements into development strategy, not treating them as an afterthought.

Second, investment in physician education around assay interpretation is lacking. Only 38% of oncologists report high confidence in using multipanel somatic testing to guide care decisions. Closing that gap is an area where pharma has both the resources and the incentive to act.

Third, the community oncology setting deserves more attention. Most patients are treated outside academic centers, where testing access and genomics literacy remain most uneven. Commercial and medical affairs strategies that assume academic-center testing quality will systematically miss a large share of eligible patients.

The broader framing matters too. As pipelines increasingly depend on nuanced biomarker selection (resistance markers, emerging targets like HER2 and cMET overexpression, co-mutation status), testing quality becomes a determinant of commercial outcomes. The companies that treat diagnostic infrastructure as a strategic priority, rather than an implementation detail, are better positioned as the precision oncology landscape matures.