A Prescription for Improving Biomarker Testing for More Patients

Finding a drug that’s the right match to fight a specific cancer—that’s the promise of precision medicine. Increased use of biomarker testing over the past decade has helped clinicians identify patients who might benefit from targeted therapies, leading to improved outcomes in many cancers. In non–small cell lung cancer (NSCLC), for example, the FDA has approved nearly 40 therapies with genetic driver alterations.¹

Despite these advances, many patients are never tested: More than a decade after the first targeted therapy was approved in NSCLC, only 37.1% of patients with this cancer receive a biomarker test.² Smaller shares of patients with bladder cancer (18.7%) and prostate cancer (13.6%) are tested, despite recent strides in those diseases.²

It turns out the path to a useful test result is an obstacle course—one full of opportunities for things to go wrong. A new white paper, published on November 10 by Johnson & Johnson Scientific Affairs, outlines how biomarker testing remains an area that lacks standardization, leaving many patients behind.

The paper, “Optimizing Biomarker Testing: Across the Patient Journey in Oncology,” summarizes findings of a 10-member multidisciplinary advisory panel that included medical oncologists, interventional pulmonologists, pathologists, and precision medicine physicians who practice in both hospital and community settings. It outlines why so many patients miss out on biomarker testing and offers recommendations on removing testing barriers.³

Those recommendations boil down to doing more to educate clinicians about a rapidly evolving field and to work to bring standardization to a key area of cancer care that evolved differently depending on who did the testing and where it occurred. Biomarker tests run the gamut—from home-grown tests created in academic laboratories, to companion diagnostics created for use with specific therapies, to panels for next-generation sequencing.

Jaspal Singh, MD, MHS, a specialist in interventional pulmonology at Atrium Health and a member of the advisory board, spoke with The American Journal of Managed Care^® (AJMC^®) about the findings, including the recommendation to educate each member of a multidisciplinary team on taking ownership of their role in successful biomarker testing.

Asked which improvements would yield the best results for patients, Singh keyed on good tissue collection and doing broad molecular testing early on in cancer treatment. Both are items mentioned often as essential elements in the age of precision medicine.

Getting the right quantity and quality of tissue during the biopsy “doesn't always mean fancy tools,” he said. “It just means a commitment to getting appropriate tissue and handling it effectively.”

Singh said he’s shifted his thinking over the years on how much tissue to collect as cancer care includes more targeted therapies. His recommendation is borne out in the report’s findings, which identify 2 distinct issues: Some patients are not tested, while others are, but the test fails to yield a useful result.

In other cases, test results are not interpreted correctly, or the therapy indicated is not given. Problems identified include the following:

• A 2019 claims study of patients with NSCLC found that 21.6% of patients did not have biomarker testing due to issues with the biopsy⁴
• The study found that 18.1% of the NSCLC patients with biopsy specimens did not have tests ordered or treatment started before testing. This highlights another challenge: some patients are anxious to start treatment immediately and do not want to wait for test results.⁴
• A total of 21.7% of patients with NSCLC had tests that failed to produce useful results—they were inconclusive, reported as false negative, or did not arrive within the decision window, and treatment began.⁴
• Similar problems were found in bladder cancer, where testing rates remain low even though targeted therapy for patients with FGFR alterations is now available in the first line.
• In prostate cancer, studies showed that up to 15% of patients had insufficient tissue samples, insufficient tissue quality for sequencing, or samples that were sequenced but failed to generate a conclusive report. A separate real-world study found that 33% of patients did not receive PARP inhibitors despite having test results showing HRR mutations.³

AJMC asked Singh whether variation in biomarker testing stems from lack of training, lack of awareness, or some of each.

“I think the barriers are complex,” Singh said. “We have to have some type of standardization, and that probably has to happen across multiple levels of the health care ecosystem…anywhere from health care systems to organizations to even laboratory standards.”

It’s challenging, he said, to work on bringing change to such a complex area “when the needle is moving so quickly, [and] it’s hard to do it on a large scale.”

Although the testing reimbursement landscape has improved, there remain concerns about areas such as repeat testing to monitor changes, such as the onset of ESR1 mutations.

Singh discussed the paper’s recommendations, which are as follows³:

• Offer educational resources that are tailored by specialty, both provider- and patient-facing, and “short yet relevant.”
• Help multidisciplinary teams to “take ownership” of their roles in the testing process, create opportunities to share information, and increase access to precision medicine experts.
• Standardize results that highlight actionable information, with far fewer variations in formatting; provide a “referenced explanation of suggested therapies.”
• Honor time limits by setting expectations for clinicians, staff, and patients for when results will be received. Use reflex protocols to shorten turnaround times.

“The report is sort of a call to action for folks to pay attention to these issues, to start thinking broadly about how to drill down the various elements and the potential barriers to broader molecular testing,” Singh said.

The paper outlines how to get tissue acquisition stewardship upstream, how to get molecular testing started early, and how get the process moving smoothly, Singh said, “so that the handoff to the oncologist for systemic therapy discussions happens earlier in the course and happen in a way that's more streamlined—and that we hope will lead to one better patient outcomes, with less side effects from other therapies.”

References

1. List of targeted therapies approved for lung cancer. National Cancer Institute. Updated May 14, 2025. Accessed November 7, 2025. https://www.cancer.gov/about-cancer/treatment/types/targeted-therapies/approved-drug-list
2. Dwyer Orr L, Mahmud S, Cline M, et al. Biomarker testing patterns among patients newly diagnosed with non-small lung, prostate, and bladder cancer. Presented at: 2025 ACMG Annual Clinical Genetics Meeting;March 18-22, 2025; Los Angeles, CA. Poster P144.
3. Waterhouse DM, Jain N, Shiller M, et al. Optimizing biomarker testing: across the patient journey in oncology. Johnson & Johnson. Published November 10, 2025. Accessed via email.
4. Sadik H, Pritchard D, Keeling DM, et al. Impact of clinical practice gaps on the implementation of personalized medicine in advanced non-small-cell lung cancer. JCO Precis Oncol. 2022;6:e2200246. doi:10.1200/PO.22.00246.