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A tubing material change appears to be the cause of a potentially serious problem with B. Braun hemodialysis bloodline sets that the manufacturer and FDA are warning about. The FDA said B. Braun sent an urgent medical device correction to customers about its Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines and recommended the…
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Background: The universal adoption of mobile technologies by households has created an opportunity to provide families with young children with access to high-quality oral health information at convenient times and locations. Using community agencies (eg, Head Start and public health programs) that offer parenting education is an effective approach to reaching families in low-income households. Objective: This study aimed to explore the extent to which a coordinated, in-person oral health prevention intervention, together with an accompanying smartphone app, BeReadyToSmile, is feasible to implement among caregivers of young children. Methods: The BeReadyToSmile program targeted parents of children aged 0 to 6 years attending parenting education classes. This study was designed as a single-group pre-post feasibility study that included quantitative surveys and open-ended feedback. A total of 30 parents attended an in-person session on child oral health and were invited to use the BeReadyToSmile smartphone app. Preintervention and postintervention surveys were administered to assess pediatric oral health knowledge, attitudes toward child toothbrushing, brushing intention, brushing efficacy, program satisfaction, and ease of use. Results: Significant effects were observed on parent-reported pediatric oral health knowledge, attitudes toward brushing, brushing intention, and toothbrushing efficacy. Out of the 30 parents invited to use the BeReadyToSmile app, 1 (3%) completed no sessions and 20 (67%) completed all sessions. Participants rated the app highly on measures of satisfaction and use. We found significant increases in pediatric oral health knowledge (.004), child brushing attitudes and intention (=.01), and parental efficacy regarding child toothbrushing (=.03). Conclusions: Caregivers reported positive experiences with the implementation of BeReadyToSmile, indicating the overall feasibility of delivering oral health prevention to households with young children both in person and through a facilitated smartphone app. Further studies should include a larger and more diverse sample, randomized comparison conditions, and a longer follow-up period to assess outcomes. Trial Registration: ClinicalTrials.gov NCT03637309;
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Background: Health care professionals’ perceptions of telemedicine, its usability, and the presence of organizational barriers are important determinants of the successful implementation of digital solutions in health care. In Kazakhstan, the use of international assessment instruments requires contextual adaptation. The Telehealth Usability Questionnaire-Model for Assessment of Telemedicine-Kazakhstan version (TUQ-MAST-KZ) questionnaire was previously developed and psychometrically validated by integrating elements of the TUQ and MAST frameworks to assess perceptions of telemedicine within the national context. Objective: The aim of this study was to conduct the first pilot application of the TUQ-MAST-KZ questionnaire with physicians in Kazakhstan and perform an initial assessment of the organizational, technical, and educational aspects of telemedicine implementation. Methods: This cross-sectional study involved an anonymous online survey using the TUQ-MAST-KZ questionnaire, which covers perceptions of telemedicine, formats of use, platform usability, communication-related aspects, telemonitoring, organizational conditions, and implementation barriers. Responses from 156 physicians were analyzed. Stratified nonparametric comparisons were performed by sex, age group, work experience (years), and workplace, adjusted for multiple comparisons. Results: The most used telemedicine formats were telephone consultations (78/156, 50%), video consultations (69/156, 44.2%), chats and messaging applications (57/156, 36.5%), and mobile apps (48/156, 30.8%). The Kazakhstan National Telemedicine Network was used by 14.7% (23/156). Wearable devices were used by 5.8% (9/156). Telemedicine technologies incorporating artificial intelligence elements were used regularly by 13.5% (21/156) and occasionally by 32.1% (50/156) and not used by 50.6% (79/156). Positive ratings were as follows: 48.7% (76/156) regarding the simplicity and intuitiveness of telemedicine platforms; 56.4% (88/156) regarding the timeliness of patient condition monitoring; 51.9% (81/156) regarding the effectiveness of telemedicine for the management of patients with chronic diseases. The potential usefulness of telemonitoring for earlier detection of deterioration of a patient’s condition was rated as fairly or very high by 48.7% (76/156); 41% (64/156) rated it as moderate. Only 35.9% (56/156) positively rated the connection’s reliability and stability. Regarding the accuracy of wearable device data transmission, 57.1% (89/156) responded neutrally, potentially indicating ambiguity in perception, limited personal experience, or difficulty evaluating this aspect. Readiness to recommend telemonitoring at the national level was more often rated as moderate, high, or very high (78/156, 50%; 42/156, 26.9%; 14/156, 9%, respectively). Conclusions: This pilot application of the TUQ-MAST-KZ questionnaire showed a generally moderately positive perception of telemedicine by physicians, who recognized its potential clinical and organizational value. However, we identified substantial technical and institutional barriers, including connection instability, concerns about the accuracy of data transmission, insufficient process formalization, and a need for additional training. These preliminary findings should be interpreted in light of the pilot study design; however, they may serve to inform future larger-scale research and the development of organizational measures related to physician training, protocol standardization, and infrastructure support for telemedicine implementation.
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Dating back more than a century, biobanks have outgrown their beginnings as small, local collections to become large, global facilities that store and handle millions of samples and serve thousands of researchers at any given time. Over the years, biobanks have transformed from passive repositories into active research infrastructures that are increasingly bridging the gap between medical research and clinical applications.
“Today’s biobanks have evolved far beyond sample storage,” said Yan Zhang, PhD, president of proteomic sciences at Thermo Fisher Scientific. “They are automated, digitally connected systems integrated with hospitals and health networks to ensure appropriate consent, longitudinal clinical context, and the ability to re-engage participants over time.”
As safeguards of clinical samples, biobanks fulfill a central role in the advancement of precision medicine. Access to the right samples can make or break a research project, with most researchers reporting that they have had to limit their scope of work because of difficulties obtaining the samples they need.
“Robust, population-scale biobanking enables precision medicine to move from isolated findings toward broader clinical relevance,” said Zhang. “Modern biobanks combine genomics, proteomics, and other high-dimensional omics platforms with robust data architecture, high-performance computing, and artificial intelligence (AI)-driven modeling. Dedicated data science teams integrate molecular data, longitudinal health records, and curated public datasets to generate biologically meaningful interpretations.”
Biobanks now provide the infrastructure needed to support population-scale, longitudinal studies that allow scientists to uncover molecular drivers of disease and understand their evolution over time to ultimately identify biomarkers, develop targeted treatments, and inform clinical decisions.
“We’re seeing researchers design studies with scale in mind,” Zhang noted. “They’re combining proteomics, genomics, and clinical data to generate insights that are both statistically powerful and relevant to real-world populations. There’s also a clear shift from searching for a single biomarker to building a more complete, systems-level understanding of disease.”
To navigate today’s rapidly shifting landscape and meet their core purpose of supporting cutting-edge clinical research, biobanks have to keep up with fast-moving targets. Going forward, moving from initial discovery to translation will remain the number one challenge in precision medicine. “Generating discovery insight is no longer the limiting factor,” said Zhang. “Validating, standardizing, and implementing those insights at scale is.”
One of the most transformative shifts in biobanking over the past decade has been an exponential increase in the scale of data collection and sample storage. At the forefront of this expansion is the UK Biobank, which currently stores around 18 million samples from 500,000 participants, together with imaging and biomarker data, healthcare records, questionnaires, physical measurements, demographics, lifestyle, and environmental data collected over the course of 20 years. This depth of phenotyping is what makes the data so valuable to researchers worldwide, said Martin K. Rutter, MD, professor of cardiometabolic medicine at the University of Manchester and deputy chief scientist at the UK Biobank. “When you link all that together, you can get amazing insights into the biology of disease.”
To keep up with increasing storage needs and researcher requests, the UK Biobank is now getting ready to move more than 10 million samples currently stored in its main laboratory to a new building in central Manchester by the end of the year. The new storage facility is designed to quadruple sample retrieval speed while making the whole infrastructure more energy-efficient and environmentally friendly.
The scale at which facilities like the UK Biobank operate today would have been unthinkable when it was established two decades ago. Such massive growth has been driven by rapid technological advances across genomics, transcriptomics, and proteomics, with costs continuing to fall while coverage, speed, and accuracy keep surging.
Partnerships with the pharmaceutical industry have also been instrumental in nurturing this exponential growth. This can be seen in initiatives like the UK Biobank Pharma Proteomics Project (UKB-PPP), a collaboration between the UK Biobank and 14 biopharmaceutical companies with the goal of analyzing proteomics data from 600,000 samples.
In the long run, scale provides the backbone to enable increasingly ambitious, statistically powerful studies. However, as they grow, biobanks face the challenge of navigating a constantly shifting landscape while making sure the samples and data they collect, store, and maintain are valuable to the entire research community they serve.
“Our job is to make the data available to researchers,” said Rutter. “We are involved now more than ever in connecting with research teams and trying to understand what their needs are.”
Through surveys and consultations, the UK Biobank actively gathers information to design prospective data collection programs that anticipate researcher needs. Next year, the biobank is planning a repeat assessment of its whole cohort, focusing on measurements of aging. The goal is to support researchers looking into causal pathways and mechanisms driving age-related diseases, empowering the development of preventive interventions and new diagnostics and treatments for age-related conditions.
Keeping pace with the evolving demands of researchers, industry, and the broader public is essential for biobanks to secure the funding necessary not only to operate but also to expand such vast enterprises, which remains a major challenge across this resource-intensive field.
Historically, samples collected by biobanks are biased in favor of participants who are white, middle-class, and have a higher education. This creates major disparities in the applicability of clinical research. In fact, studies have shown that patients from non-European ancestry backgrounds have not benefited equally from precision drugs approved by the U.S. Food and Drug Administration (FDA) to treat a range of cancer indications.
Even within biobanks dedicated to sampling the population of a specific region, ethnic minorities, low-income, or elderly people are often underrepresented, skewing results against the real-world populations they strive to serve. As the research community increasingly recognizes the importance of more diverse and representative patient cohorts, demand is rising for resources that address these barriers.
Representation is at the heart of All of Us, a program launched by the National Institutes of Health in 2018 to address the gap present at the time in many biobanks and sample repositories. This precision medicine initiative was designed to enroll participants who reflect the full range of populations found within the U.S., including individuals of varied ancestry backgrounds as well as those living in rural commmunities, which are rarely represented in biorepositories due in part to longstanding barriers to research participation, such as the logistical challenges of collecting samples and data from participants in remote locations.
“A lack of diversity impoverishes discovery and applicability of findings for all,” said Joshua C. Denny, MD, CEO of the All of Us Research Program.
For instance, data collected by All of Us has been used to investigate APOL1 gene variants linked to kidney disease, which are more common among people of West African ancestry. This research led to the identification of a novel APOL1 variant that can reduce the risk of kidney disease in individuals carrying high-risk variants.
The program has so far enrolled about 870,000 participants across all U.S. states, with about 80% of them representing communities that have historically been underrepresented in biomedical research. This has been achieved by emphasizing accessibility and flexible participation models; participants can enroll digitally and choose whether to share access to their electronic health records, donate biospecimens, and complete demographics and lifestyle surveys. They may also opt to provide saliva samples, simplifying logistics in rural areas with limited access to blood collection facilities.
“What works in a rural location is different from what works in a big city like New York,” said Denny. Whether it comes to location, age, or language, he emphasized the importance of adapting how the program approaches and engages each population.
Democratizing access to patient data across the research ecosystem is another major biobanking challenge that All of Us is committed to addressing. The program has established a streamlined access model that enables researchers to access the data they need in less than two hours if they belong to one of the 1,300 already approved institutions across the world. Together with central data storage and cloud-based analysis tools, their setup is designed to make the data accessible to researchers lacking the resources and local infrastructure for high-performance computing.
With precision medicine studies steadily escalating both in size and complexity, researchers increasingly seek to bring together data stored across diverse biobanks to power larger, more ambitious studies with broader scientific and societal impact. However, building the infrastructure needed to enable cross-biobank studies is still a challenge, starting with convening stakeholders to harmonize data collection standards and establish international guidelines.
Anticipating this need, in 2013 the European Union established the Biobanking and Biomolecular Resources Research Infrastructure – European Research Infrastructure Consortium (BBMRI-ERIC), which currently coordinates the activity of about 500 biobanks across 32 countries.
“Precision medicine can only move forward with a strong starting point for research,” said Jens K. Habermann, MD, PhD, professor for translational surgical oncology and biobanking at the University of Lübeck and director general of the BBMRI-ERIC. “It can be very difficult for scientists to get all the information they need in one place, and this is what biobanks can enable.”
Pulling together data from all its members, the BBMRI-ERIC has set up a central catalogue for biobanks, biomolecular resources, and other data and sample collections, which users can employ to identify relevant resources and build virtual cohorts tailored to their research needs. The consortium also works with international committees to set guidelines and support members working towards compliance with international standards.
Despite ongoing progress, there are still obstacles ahead when it comes to harmonizing biobanking practices worldwide, including data collection, annotation, storage, and sharing. Tackling differences in data protection, consent, ethical standards, and regulatory requirements across borders will be another necessary step towards broader standardization. Finally, biobanks will need to invest in cybersecurity to ensure patient data can be shared between institutions safely.
Funding will be key to successfully addressing all these challenges. On this front, biobanks face the difficult task of maintaining their existing infrastructure, staying up to date and relevant to the research community, and investing in cross-biobank initiatives. All this must be balanced with growing financial pressure on research centers, hospitals, and the governments supporting them.
As part of its 10-year roadmap, the BBMRI-ERIC is setting the goal of forming international networks that bring together more diverse biobank types, such as environmental, wildlife, veterinary, and plant biodiversity repositories. The overarching aim is to move towards a One Health approach to biobanking, where samples and data that expand beyond monitoring human populations are brought together to tackle overlapping challenges that simultaneously affect human, animal, and environmental health.
As the field forges ahead, biobanks are undergoing broad transformations in the way they operate. On the technology side, these changes are being propelled by the rise of multi-omics techniques in precision medicine research, as well as by rising demand from the research community for non-invasive patient monitoring data and longitudinal sample collection. All of these will be critical for the development of the next generation of personalized therapies and diagnostics.
“Over the next decade, biobanks are expected to become increasingly integrated into clinical and translational workflows,” said Zhang. “Proteomics, in particular, will play a growing role in helping us understand the dynamic biology of disease, enabling earlier detection, better prediction of recurrence, and more precise therapeutic strategies.”
A key driver of this shift will be AI. No longer just a supporting tool, AI is now becoming an integral part of biobank operations, contributing to real-time sample monitoring, predictive maintenance, risk management, and decision making.
On the data analysis side, Zhang has seen how AI is redirecting the focus from data generation to data interpretation. She said, “Biobanking has already enabled the collection of high-quality biospecimens linked to large-scale molecular and clinical datasets. The challenge now is extracting meaningful biological insight from that complexity.”
Although still in its early days, AI is becoming central to how researchers make use of biobank data, noted Rutter. Drawing from the UK Biobank data, recent studies have developed AI models that can predict a patient’s risk of stroke based on retinal images, calculate the risk of future disease by looking at an individual’s disease history, or spot neurodegenerative diseases like Alzheimer’s and Parkinson’s early using brain scans and physical activity data.
Going forward, Rutter expects to see biobanks moving away from static cohorts and in favor of continuous data collection, enabling more powerful predictions. For example, the UK Biobank is developing a mobile app that can track a participant’s physical activity and monitor their location and sleep patterns, offering an in-depth look at how a variety of factors affect their health with much more accuracy than self-reported surveys.
Over time, all these advances will steer clinical practice from treatment to prevention, allowing healthcare professionals to act early in the patient journey, when interventions are most effective, and eventually, even before disease develops. Ultimately, addressing complex diseases will require coordinated contributions from all stakeholders, including AI innovators, drug developers, clinicians, technology providers, and policymakers.
“The next decade will be incredibly exciting,” said Denny. “It will be all about leveraging the huge scale of resources that are just emerging today.”
Clara Rodríguez Fernández is a science journalist specializing in biotechnology, medicine, deeptech, and startup innovation. She previously worked as a reporter at Sifted and editor at Labiotech, and she holds an MRes degree in bioengineering from Imperial College London.
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Gilead Sciences has agreed to acquire German-based Tubulis for up to $5 billion, the companies said today, in a deal designed to expand the buyer’s antibody–drug conjugate (ADC) capabilities with a focus on fighting cancer.
Headquartered in Munich, privately held Tubulis has developed next-generation ADC candidates based on its own conjugation, linker and payload technologies intended to more selectively deliver diverse payloads to tumors deemed to be of high unmet need. The companies said Tubulis’ programs and platforms have broad potential across multiple tumor types, complementing Gilead’s development and commercialization expertise in oncology.
“We like the strategic fit and deal terms of the Tubulis (private) acquisition,” Daina M. Graybosch, PhD, senior managing director, immuno-oncology and a senior research analyst at Leerink Partners, wrote this morning in a research note. “This is more than an oncology bolt-on; we see real platform value in application of Tubulis’ ADC technologies to other therapeutic areas, namely virology.”
Tubulis’ lead pipeline candidate, TUB-040, is a sodium-dependent phosphate transport protein 2B (NaPi2b)-targeting topoisomerase-I inhibitor (TOPO1i) ADC that is now under study in the Phase Ib/II NAPISTAR1-01 trial (NCT06303505) assessing its safety, pharmacokinetics, and preliminary efficacy as a treatment for platinum-resistant ovarian cancer and non-small cell lung cancer (NSCLC).
In October at the European Society for Medical Oncology (ESMO), Graybosch noted, Tubulis presented data for TUB-040 showing a confirmed 50% overall response rate (ORR) and a 60% unconfirmed ORR across dose levels and irrespective of target antigen—results that were competitive with more mature datasets from leading TOPO1i ADCs.
“Though the dataset was early, and our primary outgoing question was how durability would mature, we suspect that Gilead saw durability maturing positively in their diligence,” Graybosch added. “If TUB-040 proves active in NSCLC, the program could complement their Trodelvy and IO [immune-oncology] lung programs. We wonder if Gilead saw early clinical NSCLC data in their diligence and if excitement around the emerging signal drove some of Tubulis’ valuation.”
Another Tubulis pipeline candidate, TUB-030, is a 5T4-targeting ADC that according to the companies has shown promising initial clinical data across various solid tumor types. TUB-030 is currently under study in the Phase I/IIa 5-STAR 1-01 trial (NCT06657222), a first-in-human study which aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TUB-030 as a monotherapy in patients with advanced solid tumors. Tubulis has said it is developing TUB-030 for up to 13 undisclosed solid tumor indications.
The acquisition deal follows a two-year, up-to-$465 million collaboration with Tubulis launched in December 2024. Gilead gained access to Tubulis’ Tubutecan and Alco5 platforms after signing an exclusive option and license agreement to discover and develop an ADC against a solid tumor target.
At the time, Gilead agreed to pay Tubulis $20 million upfront, received an option that if exercised would have given Tubulis an additional $30 million—plus up to $415 million in payments tied to achieving development and commercialization milestones, as well as mid-single to low double-digit tiered royalties on sales of marketed products resulting from the collaboration.
“Today’s agreement follows a two-year collaboration with Tubulis, which has given us strong conviction in their programs and research capabilities,” Gilead Chairman and CEO Daniel O’Day said in a statement. “The agreement to acquire Tubulis is a significant milestone in Gilead’s progress in oncology. The company brings a clinical-stage candidate that is a potential new treatment for ovarian cancer, as well as a next-generation ADC platform and a promising early pipeline.”
“Bringing this potential into Gilead would further expand what is already the strongest and most diverse pipeline in our company’s history,” O’Day declared.
Investors appeared less enthusiastic about the acquisition, as shares of Gilead dipped 1.7% in early Tuesday trading to $137.80 as of 12:01 p.m. ET.
Tubulis is Gilead’s third announced acquisition this year. The biotech giant announced plans in March to buy Ouro Medicines for up to $2.18 billion, and in February agreed to acquire Arcellx for up to $7.8 billion—for which it agreed last week to extend its tender offer until 5 p.m. ET on April 24.
Under the acquisition deal, Gilead agreed to acquire all of the outstanding equity of Tubulis for $3.15 billion in upfront cash payable at closing, and up to $1.85 billion in payments tied to milestones.
The transaction is expected to close in the second quarter subject to expiration or termination of specified regulatory filings and other customary conditions.
Upon closing of the deal, Tubulis will operate as a dedicated ADC research organization within Gilead, with the Munich site serving as a hub for ADC innovation, building on its integrated discovery, manufacturing, and clinical capabilities to advance next generation ADCs.
Gilead said it plans to finance the transaction with a combination of cash on hand and senior unsecured notes. Gilead finished 2025 with $10.605 billion of cash, cash equivalents and marketable debt securities, up from $9.991 billion as of December 31, 2024.
The post Gilead to Acquire Tubulis for Up to $5B, Expanding Cancer ADC Capabilities appeared first on GEN – Genetic Engineering and Biotechnology News.
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Good morning. Here in Chicago, cherry blossoms are blooming, rat birth control is working, and it finally feels like spring may be upon us.
As part of President Trump’s 2027 budget blueprint, the FDA has proposed policies aimed at encouraging domestic development and manufacturing of drugs, such as making it easier for drugmakers to move into clinical testing in the U.S. and giving an “exclusivity” period to U.S.-based generics manufacturers.
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The 2027 budget that the Trump administration released on Friday is in many ways a repeat of last year’s proposal: It includes deep cuts to the National Institutes of Health, the elimination of a health research agency, and the creation of a new agency devoted to chronic diseases called the Administration for a Healthy America.
Genomic testing for advanced cancer in the U.S. is hampered by unequal access across demographic groups and needs targeted policy solutions, researchers report.
Next-generation sequencing (NGS) was not carried out for the five most prevalent types of solid tumor among thousands of patients studied, the team revealed in JAMA Network Open.
And among those who did undergo this testing, wait time significantly varied according to race, insurance status, and practice setting.
“Our findings highlight the underrepresentation of certain patient demographics in tumor genomic profiling, revealing disparities in access to standard-of-care diagnostic modalities,” reported researcher Chadi Hage Chehade, MD, from the University of Utah, and coworkers.
“These results emphasize the need for healthcare policies to mitigate these gaps.”
Precision oncology has defined a new era in cancer treatment, enabling clinicians to tailor care based on the specific clinicogenomic features of a patient’s tumor, enabling more effective and less toxic treatment strategies.
NGS has emerged as a transformative technology, enabling comprehensive genomic profiling and uncovering alterations for targeted therapies.
To examine equity of care in the field, the researchers studied electronic health record data for patients with common advanced or metastatic cancers that spanned over 800 U.S. community and academic sites across the U.S. between 2018 and 2022.
The team examined time to first NGS testing and frequency of testing for 63,294 patients, including those with metastatic breast (19.1%), prostate (6.9%), pancreatic (9.7%), colorectal (21.6%), and non–small cell lung cancer (42.7%, NSCLC).
The median age in the group was 68 years and 53.7% was female. In terms of ethnicity, 2.7% were Asian, 10.0% were Black, 6.0% were Hispanic, 61.0% were White, and 20.3% were other races and ethnicities.
The frequency of testing increased over the four-year span across all cancer types, but by the final year of study up to 40% to 50% of patients were still not receiving NGS testing.
Results showed there were differential rates of testing and longer waiting times to NGS testing in some groups.
Patients with lower socioeconomic status (SES), non-Hispanic Black or Hispanic patients, those covered by Medicare, Medicaid, or other government programs, and those treated at an academic practice setting were significantly less likely to be tested in some of cancers than patients with high SES, who were non-Hispanic White, those covered by a commercial health plan, or those treated in community practice, respectively.
Among specific cancers, Hispanic patients were significantly less likely to be tested in metastatic breast or prostate cancer, and non-Hispanic Black patients were less likely to receive NGS in advanced NSCLC, metastatic colorectal or metastatic pancreatic cancer.
The findings highlight the need to improve access to standard-of-care diagnostic modalities and serve as a call to improve NGS testing rates nationwide, said Igor Makhlin, MD, in an accompanying Commentary article.
“While the accelerating pace of research and AI-driven technology is poised to herald the next generation of discoveries that translate into greater survival for patients with cancer, we cannot ignore the increased burden to stay up to date, largely born by community oncologists who manage a wide gamut of solid and liquid cancers,” he maintained.
“Creation and adoption of innovative strategies to support clinicians in implementing breakthrough advances into their practice regardless of zip code, practice site, or other factors will require a concerted effort by all relevant stakeholders, but closing this gap in GCC is absolutely necessary. Our patients are depending on us.”
The post U.S. Tumor Testing Suffers Under Access Disparities appeared first on Inside Precision Medicine.