Technology, Partnerships, Data, and Culture Are Keys to Bringing Precision Medicine to Community Oncology

In January 2025, former FDA Commissioner Stephen Hahn, MD, and fellow panelists at the JP Morgan investors conference observed that pharma no longer follows a path of establishing a presence in one tumor type before moving to the next—today’s news is all about targets, regardless of where cancer emerges.¹

This approach, Hahn said, relies on patients receiving timely diagnostic testing. However, he described the testing arena as “a bit of a mess right now.”¹ Cutting-edge tools used at academic centers, such as Hahn’s former employer The University of Texas MD Anderson Cancer Center, may not be available in a community clinic.

Advances in diagnostics, used to catch cancer as early as possible, and the use of biomarkers, to guide treatment, have reached patients at highly uneven rates. Alongside Hahn on the panel was Dan Malarek, PhD, who is CEO of Foundation Medicine; he previewed the company’s FoundationOne Monitor assay, a blood test that will measure circulating tumor DNA (ctDNA) for both responses and resistance to therapy.² Meanwhile, panel moderator John Carroll of Endpoints News, a cancer survivor, said he’s had tests that have been in use for 50 years.

DNA strand | Image: FreePik

More than 5 years ago, the American Society of Clinical Oncology (ASCO) warned that the rise of precision medicine, in which genomic tests drive personalized approaches, matching treatments with tumor characteristics, could create new disparities in care,^3,4 particularly for low-income patients treated outside an academic center. Since then, access to biomarker testing has improved, especially when looking at next-generation sequencing (NGS), which can uncover multiple genetic variations at once. However, the landscape for biomarker testing, generally, and NGS, specifically, remains a patchwork of state laws and payer policies that offer clinical, financial, and administrative hurdles for community practices.^5,6A July 2024 study in JAMA Network Open found that most patients with metastatic prostate and urothelial cancers did not receive NGS testing, and rates were worse for patients who were Black or covered by Medicare or Medicaid.⁷

This conflicted with mandates from Congress and the FDA that called for clinical trials to better reflect populations to be treated with new therapies.⁸ In response, pharmaceutical sponsors have worked with community practices to promote diverse enrollment and achieve precision medicine solutions. At the same time, entrepreneurs have developed artificial intelligence (AI)-driven platforms to match patients with trials or therapies, taking burdens off practice-level staff.^9-11

In recent weeks, the Trump administration’s reversal of diversity, equity, and inclusion initiatives prompted the FDA to remove a draft guidance on clinical trial diversity from its website.¹² The underlying law requiring it remains, however, and as Hahn said in January, with 85% of new cancer therapies requiring a companion diagnostic, precision medicine “is here to stay.”¹

Today, community oncology has developed strong models to bring precision medicine to patients, even in the most remote locations. By leveraging technology and partnerships and by promoting a culture of research, community providers have shown that rapid improvement is possible. New transactions are announced almost daily, and Precedence Research projected on February 26, 2025, that the global personalized medicine market would double from $654.46 billion today to $1.315 trillion by 2034, with oncology making up the largest market segment at 42%.¹³

The Warning From ASCO

In 2019, ASCO published a series of reports warning that for all its promise, precision medicine could create new problems: It threatened to widen disparities between the haves and the have-nots in cancer care in a multitude of ways.^3,4

It was frustrating enough that patients taking part in clinical trials had more access to precision medicine approaches, and that these patients were more likely to be wealthy and White than those in a community clinic. As tissue samples from trial patients filled databases, resources such as the Cancer Genome Atlas became overpopulated with data that did not represent the population; a 2009 study had shown that individuals of European descent made up 95% of participants in genome-wide association studies.^4,14

What could be done? Around this time, then-ASCO President Monica Bertagnolli, MD, formed a Rural Cancer Care Task Force¹⁵ to address the fact that clinical trials and novel treatments were bypassing patients who lacked the means to travel to academic centers; an analysis of adjusted annual mortality rates from 1999 to 2019 would show that the survival gap between urban and rural older adults had increased 25-fold during that time.¹⁶

Sucharu "Chris" Prakash, MD | Image: Texas Oncology

One ASCO task force member is Sucharu “Chris” Prakash, MD, who has been medical director at Texas Oncology’s Paris, Texas, location for nearly 25 years.¹⁷ By 2020, the task force had offered its first report on the challenges of rural cancer care, which he discussed with Evidence-Based Oncology™ (EBO)—rural residents were older, with less education and income than those in cities, and their cancer outcomes were generally worse. “They are diagnosed later,” so mortality is higher, Prakash said. “Access to care is a major issue—that impacts screening and treatment. There are major barriers to insurance coverage and transportation.”¹⁷

By 2022, Prakash was Texas Oncology’s director of quality services, and he embraced one of the biggest challenges in closing the disparities between rural and urban mortality rates: making NGS the norm for every eligible patient who walked in the door with an advanced solid tumor cancer. In doing so, Prakash would help lead an initiative that would expand genomic testing across all of Texas Oncology.

Texas Oncology’s Precision Medicine Quality Initiative

As Prakash took on the quality services mantle, biomarker testing rates immediately hit his radar. Texas Oncology faced a challenge that was common in community settings—only about half the eligible patients were being tested, and sometimes rates were lower. “We were in the same boat as everybody else,” he said in a February interview. “So, that’s the initiative I thought we should do.”

Testing rates had to be consistent no matter where patients were treated, Prakash said, whether it was in an urban center or at a clinic like his, located in eastern Texas at the state’s border with Oklahoma. Thus, the goal of the Precision Medicine Quality Initiative was straightforward: All patients with advanced solid tumor cancers eligible for NGS testing should receive it.

But making this happen would require changes. “When we talk about biomarker testing, it’s all about making it easy and intuitive for the provider to order it,” Prakash said. “That’s the major reason why testing is not widely adopted—because it’s difficult, it’s time-consuming, [and] it’s expensive.”

Texas Oncology’s precision medicine program, led by Vice President Lori Brisbin, MS, MLS, partnered with Trapelo Health, creator of an online precision medicine decision support tool that could both integrate with iKnowMed, the existing electronic medical record (EMR) used by practices in The US Oncology Network, and streamline prior authorization.¹⁸ As Prakash explained, “The provider logs on, and then it guides you, step by step, based on the patient's disease type, the stage, the site of disease, the pathology findings, the histology—and shows you what tests may be on guidelines and what tests you may want to order.”

Physicians at Texas Oncology can select tests from multiple labs, Prakash explained. “Once the order is placed, then our precision medicine team does the legwork on making sure that the specimen is shipped to the appropriate lab.” When tests results come back, they are seen right away, he said.

Data presented by Prakash and Brisbin at conferences show that pairing Trapelo with the iKnowMed EMR, alongside education efforts with physicians on the importance of biomarker testing, led to an explosion in the number of annual NGS orders in 2022 compared with prepandemic levels. Information presented at the Association of Cancer Care Centers’ 2023 National Oncology Conference showed that orders for solid tumor tests jumped from 4495 in 2019 to 14,702 in 2022.¹⁸ An abstract presented at the 2023 ASCO Quality Care Symposium tracked data from January 2022, prior to the launch of the initiative, through March 2023. It showed that test orders increased 150% during the study period, highlighting the ability of even a large, multisite practice to dramatically expand a precision medicine program with the right technology, partnerships, and commitment.¹⁹

Prakash said NGS via tissue testing remains the first choice, but other testing types are used if that is not feasible. Data from the ASCO Quality abstract show that 79% of the patients received somatic broad panel NGS, 16% received NGS on liquid biopsy, and 5% were single gene/small panel tests.¹⁹

Having centralized precision medicine resources makes all the difference for physicians in far-flung corners of the state, Prakash said, but changing the ethos to “test everyone” has also been an important part of the story. “I would say we test almost every single patient [who] walks in the door in Texas Oncology, no matter where they are. It could be in El Paso; it could be in Austin, downtown Dallas or Paris, Texas.”

The next big hurdle: reimbursement.

Prakash served a term as president of the Texas Society of Clinical Oncology, and during his tenure, the group worked to get state legislators to pass a law requiring biomarker testing, which took effect September 1, 2023.²⁰ This removes a huge barrier to testing because physicians are free from spending hours writing letters of medical necessity for an NGS panel. Before the law took effect, Prakash said he wrote these letters almost daily. And the need is growing, as the number of targetable mutations has exploded in just a few years, across multiple cancers.

“This policy change, to make sure insurance companies pay for testing and patients are not tasked with paying exorbitant fees, has been critical,” he said. “We’ve seen the results.”

Meeting Diverse Needs in Nashville

Through her role as assistant professor of pharmacy practice at Lipscomb University and her practice in Nashville General Hospital at Meharry Medical College, in Tennessee, Angie Maynard, PharmD, MS, CPGx, sees the promise and challenges of precision medicine through several lenses.

Angie Maynard, PharmD, MS, CPGx | Image: LinkedIn

“The hospital serves our indigent population, including those [who] are incarcerated, those [who] are underinsured, or not insured at all,” she explained. “We also have some patients who are insured. So, we run the gamut.”

On the plus side, her institution has a strong partnership with Tempus AI, in which the testing company takes the lead in working with insurers, including for patients who are incarcerated. Tempus helps resolve transportation issues and, in some cases, goes to the patient if they cannot come to the hospital for a test, Maynard said. “We've been fortunate in that sense,” she said.

Ezra Cohen, MD, Tempus’ chief medical officer of oncology, explained how the partnerships work: Tempus Next, the company’s AI-enabled care pathway intelligence platform, integrates into an EMR to create alerts for individual patients, offering support for physicians to deliver guideline-based care.

“Guidelines are continually evolving as advancements are made and it is nearly impossible for physicians, especially those who are caring for many, many patients, to keep up-to-date all the time,” he said. “This type of technology makes it much easier for physicians to deliver personalized care as it seamlessly identifies care gaps and equips them with actionable insights at the point of care, supporting access to the most up-to-date, guideline-directed treatments.”

Clinical trials, Cohen said, have been shown to offer the best access to novel therapies, and the best outcomes for patients. To reach patients from underserved communities, Tempus’ TIME program works with community hospitals that care for these patients to activate trials on site, which he said makes it easier for patients to take part in studies.

“Through the TIME program, the need to travel and engage with far off academic medical centers in order to participate in clinical trials is eliminated,” Cohen said.

For Maynard, the biggest challenges these days come not with access to testing, but when biomarkers show that a patient with cancer needs a newer therapy, one that will require the patient to apply for financial assistance. Tennessee does not have Medicaid expansion under the Affordable Care Act, and Maynard has seen cases in which patients who are out of work due to cancer still miss qualifying for help. In some scenarios, patients who are too ill to live alone move in with a family caregiver, with unintended consequences.

“That's our biggest problem. We’ve had several patients who have to live with family members in order to have supplemental care,” triggering a rejection because now the application must capture the entire household income. “You have to report everything for patient assistance, and that family member maybe makes just enough more money [to exceed the standard].”

Both Prakash and Maynard said today’s challenges revolve less around getting access to testing and more around the speed with which oncology care is changing—and the fact that clinical guidelines don’t always keep pace.

“It’s a moving target,” Prakash said, because as technology evolves, ctDNA testing improves, and more care incorporates the use of minimal residual disease testing.

Maynard agreed. “The one thing I’ll say about precision medicine, in the space we work in, is that I wish we had a board just for that—we have a tumor board, but not a board for precision medicine.”

A National Perspective on Payer Coverage

From his vantage point, Tempus’ Cohen has seen both positive changes in precision medicine reimbursement since the ASCO reports, as well as examples where restrictive definitions of “clinical utility” create barriers to access.

“Medicaid coverage for cancer genomic testing varies widely at the state level, because Medicaid is a joint federal-state program, meaning states have flexibility in setting their own coverage policies,“ he said in an email to EBO. States that with Medicaid expansion have, “in some limited cases, created broader coverage and reimbursement for precision medicine testing in the form of comprehensive genomic profiling.”

Cohen said that passing laws such as the one in Texas, which seek to cover all genomic testing outside of ERISA plans, offer “a theoretical guarantor of reimbursement in the Medicaid population, although the true impact of these mandates is yet to be realized.”

He explained that reimbursement is subject to interpretation, citing language that says coverage is provided “when the test provides clinical utility as demonstrated by medical and scientific evidence.” Restrictive definitions of clinical utility may be supported by non-current clinical literature citations, which Cohen said create barriers to reimbursement.

“This translates to coverage interpretations of clinical utility specified by a Medicaid payer policy that only reimburses small panel genomic testing mixed with mostly non-NGS technologies,” Cohen said. “These would remain outside of ASCO interpretation of precision medicine cancer care, and in some states, this trend is reducing access to coverage, often when benefits are delegated to a third-party lab benefits management company.”

Using AI to Help Clinicians Make Decisions

Technology gave Texas Oncology the boost it needed to make NGS the norm for solid tumor patients. Now, technology may offer solutions to the challenge Maynard outlined: how to easily interpret test results and make the best treatment choices, given the ever-increasing number of options.

The positive side of NGS is that it captures multiple genomic factors that could be driving cancer. However, the downside is that the FDA regulates the makeup of commercial lab reports, which cannot point physicians in a clear direction if there are multiple potentially actionable targets. That’s where specialized expertise is needed, and in the future, much of this decision-making will be driven by AI.

If 5 years ago community oncology was seen as catching up in precision medicine, today large practices and multipractice networks have the upper hand in a key area: Eighty percent of cancer care happens in the community,²¹ and practices have the data.

Several large practices have created precision medicine subsidiaries as they leverage their data to form partnerships and pursue research. Texas Oncology formed Precision Health Informatics, LLC (PHI); in July 2024, PHI announced a partnership with COTA to develop AI-driven precision medicine models.²² Just before the Florida Cancer Specialists & Research Institute joined The US Oncology Network last year, it formed Vita Nova Insights through its subsidiary CORE Ventures.²³

MiBA, or Meaningful InsightsBiotech Analytics, launched in April 2024, under leadership from the American Oncology Network and Ascend Technologies Group.²⁴ MiBA has lined up several partnerships: Guardant Health, Foundation Medicine, and more recently, Clarified Precision Medicine, which specializes in interpreting test results.

Clarified, highlighted in EBO in 2024 for its mission to cover the “last mile” in precision medicine,¹¹ seeks to bridge the interpretation gap by using AI to create ranked treatment recommendations, which are then reviewed by qualified experts. The resulting report highlights which treatment choices are considered first options—and which ones are not recommended, based on evidence that the patient will not respond.^11,25

Case studies of how the process works in a real-world setting are presented in a new white paper, “Unraveling the complexity of therapeutic decision-making,” which Clarified published February 26, 2025.²⁵ The white paper states that this technology is especially valuable to managed care and market access teams “tohelp improve patient outcomes and reduce costs.”

Rajni Natesan, MD, MBA | Image: Clarified Precision Medicine

In an interview, Clarified CEO Rajni Natesan, MD, MBA, said community oncology practices were viewed as ideal candidates for the technology early on. But in cancer care today, only a small number of cases will make it to a tumor board, no matter the setting. “Guidelines change,” Natesan said. “Even at an academic center, where there is expertise, there is a scalability problem.”

If keeping pace with innovation is the next challenge, Texas Oncology’s Prakash is ready. Simply put, he said, every patient with advanced cancer eligible for NGS should receive it.

“It’s been a journey,” Prakash said. “It's been a challenge in a lot of ways. To change habits—to change the culture—is difficult. Back when I started doing this, our testing rates were less than 50% of all advanced cancers…

“This is what we want to do for our patients and for the advancement of oncology.”

References

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