NEW YORK – Leading cancer centers and healthcare systems in the US are continuing to improve patients' access to molecular testing for personalizing treatment, assessing cancer risk, and predicting adverse events, Precision Medicine Online's annual survey has found.
Experts from around the country who were surveyed in late 2024 indicated that their institutions' ongoing investments in precision oncology capabilities are allowing more patients to receive medically appropriate tumor molecular profiling, especially in earlier disease settings; undergo germline genetic testing to gauge their hereditary cancer risks; and obtain pharmacogenomic testing to assess their ability to respond to medications and their risks for adverse events. Moreover, the majority of surveyed institutions have either implemented or are evaluating artificial intelligence (AI) algorithms that can personalize treatments for patients.
Meanwhile, other challenges in precision medicine have proven more difficult to resolve for the field. For example, the 2024 survey, which included responses from 23 precision medicine experts mostly at well-resourced cancer centers and health systems around the country, doesn't suggest much improvement year over year in addressing stubborn operational and implementation problems, like long wait times for autologous CAR T-cell therapies and low clinical trial enrollment rates based on biomarkers.
This is the sixth year Precision Medicine Online has done this survey to track the investments US cancer centers and hospitals are making to improve patients' access to precision oncology — a term that comprises biomarker-informed drugs, autologous CAR T-cell therapies, and treatments designed to replace, correct, or attenuate the genetic abnormality responsible for a disease. Between October and December of 2024, Precision Medicine Online reached out to individuals at small and large cancer centers, hospitals, and community practices in the US who are integrally involved in precision oncology programs and have knowledge of related activities. The 23 respondents to the 2024 survey included oncologists, professors, program or cancer center directors, physician scientists, nurse navigators, genetics experts, and pathologists.
More than half of the 23 experts work at National Cancer Institute-designated comprehensive cancer centers, less than 20 percent work at academic institutions or cancer centers within large healthcare systems, and more than a quarter are at cancer centers within a nonprofit or for-profit healthcare system. Although some of the surveyed healthcare institutions and cancer centers do serve rural and low-income populations, most of the respondents work at healthcare organizations that are likely better resourced than many community hospitals and local, standalone private practices where most cancer patients in the US receive care.
Nearly all respondents at these top-tier institutions — 21 — indicated that in the past year their employers made new investments that improved their ability to practice precision oncology. Twelve, or nearly 60 percent, said they hired new personnel with expertise in precision oncology and molecular diagnostics. A similar proportion set up an in-house molecular tumor board (MTB) or enabled access to an external group of experts that can help oncologists parse their patients' molecular profiling reports and determine the best course of treatment. Around 50 percent of respondents said their institutions set up clinical decision support within the electronic health records (EHR) system to let physicians know when patients need testing or have actionable results. A quarter of the surveyed institutions hired precision oncology support staff like nurse navigators who can, for example, help patients navigate the multistep process of getting tested and ensure that results are reviewed by doctors in a timely fashion.
One respondent wrote in that the institution automated its next-generation sequencing lab and installed upgrades into the EHR system in 2024. Another indicated that no new hires were made in 2024, while another said that the institution already had a longstanding MTB.
As in prior years, a variety of molecular testing options, critical to identifying patients eligible for biomarker-targeted therapies, are available at surveyed institutions through in-house and commercial labs. In 2024, similar to what has been seen in past surveys (see 2019, 2020, 2021, 2022, and 2023 data), institutions are more likely to perform in-house single-gene and NGS panel testing and send out liquid biopsy and immunotherapy testing as well as exome, whole-genome, and RNA sequencing to commercial labs.
In fact, two-thirds of respondents said they preferred to send out testing to commercial labs when they needed to order a more expansive panel of biomarkers, while close to 60 percent felt an in-house lab would be the better choice when trying to reduce out-of-pocket costs for patients. When doctors need results quickly or want a more customized panel, 56 percent preferred an in-house lab while 44 percent preferred a commercial lab.
For the last two years, Guardant Health has been the commercial lab respondents cited most often when asked which labs their institutions outsourced molecular testing to, likely reflecting the popularity of liquid biopsy testing, particularly minimal residual disease assessments. In 2024, other oft-cited commercial labs included Foundation Medicine, Tempus, Caris Life Sciences, and Natera. Myriad Genetics, NeoGenomics, Laboratory Corporation of America (or its subsidiary Invitae), Mayo Clinic, and Exact Sciences were also cited but less often. Strata Oncology, Ambry Genetics, Fulgent, and Kylos each got one mention.
With the increasing availability of biomarker-informed cancer medicines in earlier disease settings in recent years, oncologists have been more willing to molecularly profile patients when their tumors are in more curable stages. In the first survey back in 2019, around 20 percent of respondents said patients with stage IV/advanced tumors were the earliest they offered molecular testing to, while 42 percent said they were testing those with stage I tumors. By 2023, only 10 percent said they didn't begin offering testing until patients had advanced to stage IV disease, and slightly more respondents, 45 percent, indicated they were offering testing to patients with stage I tumors.
2024 is the first year that none of the surveyed institutions reported that they are limiting molecular profiling to only those patients with advanced disease. A dozen respondents indicated patients with stage I tumors are being offered molecular testing, seven said patients with stage II tumors were offered such testing, and four said patients with stage III tumors are being offered molecular testing.
In recent years, there's been growing awareness about the need to test patients' inherited mutations in cancer risk genes if, for example, they have a strong family history or have been diagnosed with certain types of cancer, or when tumor profiling results suggest the possibility of a cancer predisposition. Nine respondents, or nearly 40 percent, said more than 50 percent of patients at their institutions were receiving germline genetic testing when appropriate to assess their risk for cancer, while 11 respondents, or nearly 48 percent, estimated that between 10 percent and 50 percent were receiving such testing. None said less than 10 percent received such testing, while three respondents said their institutions didn't track this.
More oncology divisions are embracing pharmacogenomic (PGx) testing, too. Sixteen respondents, or nearly 70 percent, said oncologists at their institutions were encouraged to order preemptive PGx testing compared to last year when only 47 percent said institutions were supporting such testing.
Patient advocacy groups have been urging cancer centers to set up preemptive PGx testing to identify patients with pathogenic DPYD variants who are at risk for serious, sometimes deadly adverse events to commonly prescribed fluoropyrimidine chemotherapies, like 5-fluorouracil and Xeloda (capecitabine). Spurred by petitions from doctors, patients, and their families, the US Food and Drug Administration updated the labels of these drugs in 2022 and 2024 with stronger language highlighting the risk for adverse events in patients harboring these variants. Reflecting the increased focus on this pharmacogene, nearly all the institutions with preemptive PGx testing programs are testing for DPYD pathogenic variants as of last year.
Oncologists at a dozen surveyed institutions are also preemptively testing patients for variants in UGT1A associated with metabolizing the chemotherapy irinotecan, while nine respondents noted that preemptive testing for CYP450 variants, involved in metabolizing many commonly prescribed drugs, was occurring at their institutions. Several respondents mentioned their institutions are testing for TPMT and NUDT15 variants associated with metabolizing thiopurines, while a few institutions have implemented a broad PGx panel based on recommendations from the international guidelines body Clinical Pharmacogenetics Implementation Consortium.
At the seven institutions without a preemptive pharmacogenomics program, respondents more commonly attributed this to the lack of knowledge among oncologists about this type of testing, followed by the lack of support from the FDA or guidelines bodies for PGx testing and that leaders at the institution aren't convinced about the clinical utility of such testing. Several noted that leaders at the institution didn't support investments necessary to set up preemptive testing, and a few mentioned concerns about limited reimbursement for PGx testing.
Despite steady expansion of precision oncology test availability at surveyed institutions, not all eligible patients are receiving necessary molecular profiling, potentially missing opportunities for personalized care. Insufficient tissue was the biggest reason 16 out of 23 respondents cited for why eligible patients at their institutions may not receive biomarker testing or may not have results in time to influence therapy decisions. The lack of targetable biomarkers, patients being too sick to undergo testing, insurance authorization delays, and long test turnaround times were other common reasons for patients not getting tested. A few also mentioned the lack of physician awareness, social, economic, and geographic disparities, and difficulty interpreting reports as barriers to testing, while one respondent wrote in that sometimes an external hospital where patients are receiving care doesn't send tissue for biomarker testing.
Beyond biomarker testing, top cancer centers and hospitals are also starting to invest in or explore AI algorithms that can help oncologists identify the best treatments for patients. Three respondents, 13 percent, said their institutions had already implemented AI algorithms for personalizing treatment options within precision oncology programs, while six respondents, 26 percent, indicated they were expecting to implement treatment-predictive AI algorithms in six to 12 months. Five respondents, 22 percent, expect implementation of such algorithms could take more than a year, and the same proportion said that evaluations were ongoing at their institutions but there was no set time frame for when these algorithms would be integrated into patient care. Four respondents, 17 percent, said their institutions aren't currently evaluating AI algorithms within precision oncology programs.
Molecular testing and AI algorithms are also necessary for matching patients to clinical trials, which are often their best chance of receiving precision oncology treatment. However, like prior years, the 2024 survey continues to show that a minority of cancer patients at surveyed institutions are being matched to a trial based on a biomarker. Seventeen out of 22 respondents said 20 percent or fewer patients were being enrolled in precision oncology trials at their institutions; four respondents estimated that between 20 percent and 30 percent of patients were being enrolled; and only one expert said that more than 50 percent of patients were getting on such trials.
Of the 17 respondents who indicated that 20 percent or fewer patients were getting on biomarker-informed trials, 12 experts, or around 70 percent, said this was because there weren't enough studies open for patients to join, and 10 experts, or around 60 percent, noted that patients couldn't get on trials because they didn't match all the enrollment criteria. Five respondents, 30 percent, said patients refused to travel to faraway study sites, and three experts, under 20 percent, said patients couldn't partake in a trial to which they matched because of associated costs.
The complex logistics of advanced precision oncology therapies, like autologous CAR T-cell treatments, also present significant barriers to patient access. In the 2024 survey, 11 out of 22 respondents said that more than 50 percent of patients eligible for such treatments were receiving them at their institutions. Six respondents estimated that 50 percent of patients or fewer were receiving CAR T-cell therapies, while four experts said their institutions didn't have the expertise or resources to provide such treatments and that patients are being referred to other facilities or clinical trials.
Autologous CAR T-cell therapy involves collecting a patient's T cells, genetically engineering them in a lab so chimeric antigen receptors can recognize and attack cancer cells, and infusing the modified cells back into the patient. The lengthy process can hinder access, especially for rapidly declining, late-stage cancer patients who don't have a month or longer to wait to receive this bespoke therapy. Data from the 2023 and 2024 surveys suggest that there hasn't been much improvement when it comes to development times, and most patients are still waiting between one and three months to receive CAR T-cell therapies.
Radionuclide therapies, a rapidly growing area of precision oncology, also require hospitals to hire experts, procure licenses for radioactive materials, and invest in specialized labs and imaging equipment. In 2024, the majority of respondents were from well-resourced institutions and said that their hospitals and cancer centers had the capabilities to offer patients radionuclide treatments in-house.
When asked what the biggest challenge oncologists at surveyed institutions faced in implementing precision oncology, respondents most often mentioned limited access to clinical trials, which has remained among the top three barriers noted by respondents over the past five annual surveys. Insurer coverage denials for off-label treatments based on biomarker testing results and limited biomarker test result integration in EHRs were other top challenges mentioned by experts.
Ultimately, precision oncology advances don't matter if patients aren't receiving them or benefiting from them. To ensure that eligible patients are receiving appropriate biomarker testing and personalized therapies, surveyed institutions are relying on MTBs, according to nearly 60 percent of respondents, and leaning on intermediaries like nurse navigators, said 35 percent of respondents. Thirty percent said their institutions use information in the EHR to flag those who need biomarker testing; and around a quarter of respondents said they share patient access metrics with doctors; while one person wrote in that they have a molecular pathology task force that identifies access gaps. Seven respondents said their institutions don't have any systems in place for identifying gaps in precision cancer care.
Finally, when asked what metrics institutions use to measure the success of their precision oncology programs, like prior years, respondents most commonly cited the proportion of cancer patients getting biomarker testing and the number of patients getting on trials based on test results. Around 30 percent said their institutions consider how many patients are going through MTB review or getting on MTB-recommended drugs as a marker of success, while a quarter said their institutions pay attention to how well patients are doing on molecularly informed treatment. One person wrote in that the institution also factors in genetic counselors' referrals, cost-effectiveness, and the time saved by physicians when considering the impact of the precision oncology program.
However, even as institutions continue to invest in precision oncology, an appreciable portion of healthcare organizations in the 2024 survey are not tracking whether these tests and treatments are actually helping cancer patients live longer and better. In 2024, eight out of 23 respondents said there were no success metrics at these top-tier institutions, suggesting that 35 percent of surveyed hospitals and cancer centers have little insight into the return on investment from their precision oncology programs.
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