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In today’s era of personalized cancer care, diagnosing a person’s cancer typically requires knowing their biomarkers. By first testing a patient’s tumor tissue or blood for genetic drivers that might be causing cancer’s growth and spread, a physician can potentially match each patient with available treatment options, such as targeted treatments, and offer the best chance at a positive outcome. 

Closing gaps in biomarker testing is now a major imperative for the cancer community. Studies show that a large share of patients still don’t get tested for all the relevant biomarkers that can help personalize their care.1,2 Reasons for these gaps are varied, ranging from insurance gaps to logistical challenges, and they often converge in the physician’s office where critical decisions about biomarker testing are made together with the patient.

“For someone facing a new cancer diagnosis, biomarker testing is a key first step to determine what therapies are optimal to treat the disease,” says Dr. Jamie Freedman, who heads U.S. medical affairs at Genentech. “If we want every patient to benefit from the incredible progress we’ve achieved in personalized medicine, then all of us working in cancer care need to help dedicated physicians confront practical barriers to biomarker testing for the patients under their care.”

Dr. Freedman adds that Genentech is working with other Roche Group companies on comprehensive biomarker testing and the Electronic Medical Record system to help expand access. “To meet our goal of personalizing care for each unique patient with cancer, we have to help ensure every patient can receive a complete, personalized diagnosis.”

Physicians embrace testing, but need help 

A physician’s recommendation is an important factor in determining whether patients are tested for biomarkers. In a recent survey by the Association of Community Cancer Centers (ACCC) and the lung cancer advocacy group LUNGevity, for example, patients cited their oncologist as their primary source of biomarker testing information.  

“There’s no lack of enthusiasm or understanding about biomarker testing in our profession,” says Dr. Davey Daniel, chief medical officer for OneOncology, a clinical and management services platform for more than 850 cancer care providers at private oncology practices across the United States. “In our partnership, physicians readily identify how important it is to provide comprehensive biomarker testing to their patients, and they’re looking for guidance and support to overcome very real challenges associated with performing and applying these tests in routine patient care.”   

Dr. Daniel adds that while oncologists don’t question the importance of testing, they often face uncertainty in choosing which tests to use for which patient: “There’s no perfect test across all patients and situations, but rather a best test for a given patient and point in time. To physicians on our platform, our message is ‘test until you’re sure you can offer your patient an answer that will help to guide their care.’” 

In many cases, that answer can be secured by testing for all potentially relevant biomarkers using next-generation sequencing (NGS). While NGS can involve greater up-front costs than single-gene tests, research suggests that, overall, it can shorten the time to results and reduce overall costs to health systems versus testing for multiple, individual biomarkers in sequence.3

But research also points to an array of other challenges that physicians and their patients face. One of those is navigating insurance barriers, such as prior authorization requirements, which can be especially burdensome for patients on public insurance. A recent study by Yale University and Genentech researchers found that Medicaid beneficiaries with advanced non-small cell lung cancer (NSCLC) were 19 percent less likely than commercially insured patients to receive biomarker testing, and were 30 percent less likely to be treated with biomarker-driven therapy.4

Other challenges are more logistical, including insufficient or poor quality tissue samples, technical errors and delayed results. In a Genentech-sponsored study among people newly diagnosed with advanced NSCLC, challenges like these were among the reasons that almost 65 percent of potentially eligible patients did not receive a personalized treatment.5As evidenced by a recent ACCC survey, such challenges can be especially acute in private practice, where physicians may not have the resources of an academic medical center. Also known as community oncology practices, these facilities serve a large share of people with cancer in the United States. 

Partnership aims to identify practical solutions for all communities

At OneOncology, leaders believe barriers can be overcome. Starting in 2019, they launched a network-spanning initiative to drive adoption of personalized cancer care, with particular emphasis on biomarker testing. In late 2020, Genentech joined the effort, bringing not only its longstanding scientific expertise, but also the analytical and diagnostic resources of its sister companies within Roche. 

“Together with OneOncology, we found a unique opportunity to advance a common goal of expanding access to personalized cancer care,” says Dr. Freedman. “With our complementary roles and combined resources, we hope to develop, test and share solutions that can make personalized cancer care possible at practices everywhere.” 

In its first phase, OneOncology’s initiative focused on increasing use of NGS by providing its physicians with the opportunity to participate in weekly molecular “tumor boards,” in which specific cases are reviewed and opportunities for biomarker-driven therapy discussed. 

More recently, with insights and analytical resources from partners like Genentech, OneOncology has launched a more comprehensive push to normalize biomarker testing for patients with advanced cancers. Among the most ambitious are new decision-support tools to flag for a physician when a previously identified biomarker may be relevant to next steps in a patient’s treatment plan.

“From our standpoint, every patient deserves expert genomics advice to guide their cancer care,” says Dr. Daniel. “We recognize that physicians can’t all be experts at genomics, but they and their patients should all have access to that information and support.”

Dr. Freedman agrees, noting that Genentech and OneOncology researchers are using real-world data analytics to study how biomarker testing and treatment patterns differ between OneOncology practices and the broader cancer community. Over time, they’ll also help to gauge the impact of the collaboration on patient care and hope to provide insights to the cancer community through journal publications and other venues.

“We’ve always considered working with the healthcare community essential to everything we do,” he says. “In this case, we’re confident that by joining efforts with OneOncology, we can truly expand access to personalized cancer care for people with urgent unmet needs.”

References

1. Bruno DS, et al. Racial disparities in biomarker testing and clinical trial enrollment in non-small cell lung cancer (NSCLC).ASCO 2021 Meeting Abstract. Available online at: https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.9005. Accessed on October 28, 2021.
2. Robert NJ, et al. Biomarker tissue journey among patients (pts) with untreated metastatic non-small cell lung cancer (mNSCLC) in the U.S. Oncology Network community practices.  ASCO 2021 Meeting Abstract. Available online at: https://meetinglibrary.asco.org/record/197070/abstract. Accessed on October 28, 2021.
3. Pennell NA, Mutebi A, Zhou Z-Y, et al. Economic impact of next-generation sequencing versus single-gene testing to detect genomic alterations in metastatic non–small-cell lung cancer using a decision analytic model. JCO Precis Oncol. 2019;3:1-9.
4. Gross C, Meyer C, Ogale S, et al. Associations Between Medicaid Insurance, Biomarker Testing, and Outcomes in Patients With Advanced NSCLC. J Natl Compr Canc Netw 2022;20(5):479–487.
5. 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 Precision Oncology no. 6 (2022) e2200246. Published online October 31, 2022.