Addressing Biomarker Testing Gaps in NSCLC: Shiven B. Patel, MD, MBA

Scant tissue samples remain a significant obstacle to comprehensive biomarker testing in non–small cell lung cancer (NSCLC), but a combination of concurrent tissue-and-blood testing, mobile phlebotomy, and telehealth is helping bridge the gap for patients, particularly those treated far from major cancer centers, Shiven B. Patel, MD, MBA, of Huntsman Cancer Institute, explained in an interview at an Institute for Value-Based Medicine® event last week in Salt Lake City, Utah.

As moderator of the panel “Precision in Practice: Implementing Biomarker Testing in Lung Cancer,” Patel said higher-yield biopsy techniques and better collection technology could help address tissue limitations. In the meantime, blood-based circulating tumor DNA (ctDNA) next-generation sequencing (NGS) has become a valuable supplement when tissue is limited. However, it has its own limitations, as ctDNA is not always detectable in blood, RNA sequencing is not yet reliable on blood samples, and immunohistochemical (IHC) stains used for markers like PD-1 still require tissue.

That said, Patel emphasized a reassuring point about balancing broad testing against tissue and cost constraints: comprehensive sequencing already captures most DNA- and RNA-based alterations as testing panels have expanded, so newly discovered alterations typically do not require additional tissue beyond what is already being collected. The main added burden comes when a new IHC-based test is needed, he noted.

To reduce turnaround time, Patel said he orders tissue and blood testing concurrently, since blood results typically return within about a week. If blood results are positive, targeted therapy can start right away. If results are negative and the patient is clinically stable, he waits for tissue confirmation before starting chemoimmunotherapy. For patients too sick to wait, chemotherapy begins without immunotherapy for one cycle, with immunotherapy deferred specifically to avoid added toxicity risk if a later switch to targeted therapy is needed; results are usually available before the next cycle.

For patients living far from a cancer center, Patel explained that testing companies often retrieve tissue directly from local hospitals and offer mobile phlebotomy services, sending technicians to patients' homes for blood draws. Telehealth, which he is licensed for across 8 states, also avoids unnecessary long-distance travel for routine result discussions.

Looking ahead, Patel said more education is not the priority, as awareness of the importance of biomarker testing is already widespread. Instead, the need is continued investment in access to tele-oncology for areas without local oncologists.

“If we can improve access to high-quality oncology in rural areas, access to biomarkers will come with that,” he concluded.