Biomarker Testing: A Key Component To Advancing Precision Medicine
By Omar Perez, Ph.D., head of medical diagnostics, U.S. Medical Affairs Oncology, AstraZeneca
The immense advancements made in the field of precision medicine in recent years have steered us into a new age of cancer care – one with the potential to save more lives than previously thought possible through personalized, early intervention and customized treatment plans. We’re living in an age with more targeted therapies on the market than ever before, and scientists tirelessly continue researching ways to further improve how we detect and treat cancers of all kinds.
However, if these technologies aren’t actually getting to the patients who need them, when they need them, the promise of precision can only go so far. Biomarker testing isn’t always the standard of care for many people living with cancer today. Even as someone with 20 years of experience working in the oncology field and having survived kidney cancer myself, I’ve personally lost loved ones to cancer because biomarker testing either wasn’t conducted at all or results weren’t received or acted on in time to help inform treatment plans in ways that might have changed outcomes. So, in 2022, why isn’t biomarker testing routine for people with cancer the same way preventive screenings are for all – and more importantly, how can we change this reality and give as many people as possible their best chance at survival?
Addressing Biomarker Testing Education Needs Among Providers And Patients
Our conversations with stakeholders from across the oncology community consistently reveal that one of the biggest barriers to the broader utilization of biomarker testing stems from the complex and constantly evolving nature of the precision medicine landscape itself.1,2
Rapidly changing guidelines and innovations can make it challenging for healthcare providers to keep track of the many different tests available and know when they should be used.1 Many also face difficulties obtaining proper biopsy samples for biomarker testing,3 and the outputs can be laborious both to interpret and communicate back to patients.4,5 Access to more educational resources – such as a consolidated, central source for current guidelines and standards for interpreting results quickly and accurately – is needed to help providers better understand precision medicine and effectively incorporate it into their practice.5
Significant educational gaps are often seen on the patient side as well. Not all people with cancer know they can advocate for themselves to receive biomarker testing, and some may not be familiar or understand the process enough to request it from their healthcare providers.6 As a start, the use of more consistent and straightforward terminology across the board can play a key role in increasing patients’ knowledge of biomarker testing and ultimately improve communication between patients and their care teams.5,6
Ensuring that patients and providers have the tools they need to have these types of effective two-way conversations is a critical step to improving the clinical utility of precision medicine.
Implementing Standardized Care Approaches From A Pan-Oncology Perspective
These educational barriers also contribute to inconsistent standards of care across oncology institutions. Precision medicine, for example, is more widely used in academic medical centers than in community hospitals.7 This means that providers at community hospitals – where approximately 80 percent of cancer patients receive care8 – are both less familiar with precision medicine and less likely to have access to the tools needed to incorporate it into their daily practice compared to their counterparts in academic settings.9 Biopsy and testing procedures may also vary across institutions. Logistical issues around tissue acquisition, identifying and performing appropriate testing, communicating results, and conducting payer coverage assessment may impede the use of precision medicine in community settings where these processes may be less centralized.9 Taken together, this lack of consistency – both among testing processes and standards of care – leads to lower adherence to testing guidelines and a widespread sense of frustration and confusion among providers and patients looking for answers.10 We must work to identify efficiencies and implement uniform testing procedures wherever possible to ensure that precision medicine is the standard of care for everyone, everywhere.
Advocating For Equitable Access To Biomarker Testing
We cannot make this a reality without addressing the lack of equitable access to biomarker testing for people with cancer.
In addition to geography, many other factors can limit access – for example, socioeconomic status, health literacy levels, and language and cultural communication styles.11 As such, expanding community care providers’ and institutions’ access to clinical trial recruitment and enrollment is one of the most critical steps we can take to make biomarker testing more readily available to the broader population.12 In doing so, we can simultaneously further the science by ensuring that trials are more inclusive of the many underrepresented populations disproportionately impacted by cancer and enable all patients – regardless of their circumstances12 – to benefit from this revolution in cancer treatment.
Dismantling each of these barriers to accessible biomarker testing will be no easy feat. Still, we can drive long-lasting change if we come together and harness the collective expertise of the oncology community. At AstraZeneca, we are collaborating across disciplines, fostering meaningful partnerships and continuing with open dialogue, as we believe that together we can identify the most effective solutions to these complex issues and establish biomarker testing as essential to high-quality cancer care for all patients, so that no one misses out on the extended future that precision medicine can bring.
- IQVIA Institute for Human Data Science. Optimization Oncology Care Through Biomarker Adoption: Barriers and Solutions. Retrieved July 27, 2022, from https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/optimizing-oncology-care-through-biomarker-adoption.pdf?_=1631306717755.
- AstraZeneca YOURCancer. New York Precision Medicine Roundtable Recap. Retrieved July 27, 2022, from https://yourcancer.org/wp-content/uploads/2021/10/YOURCancer_Precision_Medicine_Roundtable_NewYork_Recap-pdf-passed.pdf.
- Pennell NA, Arcila ME, Gandara DR, West H. Biomarker Testing for Patients with Advanced Non-Small Cell Lung Cancer: Real-World Issues and Tough Choices. Am Soc Clin Oncol Educ Book. 2019;39:531-542.
- Guglielmino J, Friedman S. The Road Ahead: Using Common Language to Improve Patient Understanding, Communication, and Uptake of Cancer Testing. ASCO Connection. Retrieved July 27, 2022, from https://connection.asco.org/blogs/road-ahead-using-common-language-improve-patient-understanding-communication-and-uptake-cancer
- WS Collaborative. A White Paper on Need for Consistent Terms for Testing in Precision Medicine. Common Cancer Testing Terminology. Retrieved July 27, 2022, from http://www.commoncancertestingterminology.org/files/Consistent-Testing-Terminology-Whitepaper-070720.pdf
- Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies; Board on Health Care Services; Institute of Medicine; National Academies of Sciences, Engineering, and Medicine; et al. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine: Processes to Improve Patient Care. National Academies Press (US). 2016. Retrieved July 27, 2022, from https://www.ncbi.nlm.nih.gov/books/NBK379329/
- Fohner AE, Volk KG, Woodahl EL. Democratizing Precision Medicine Through Community Engagement. Clin Pharmacol Ther. 2019;106(3):488-490. doi:10.002/cpt.1508
- Garg AK Community-based Cancer Care Quality and Expertise in a COVID-19 Era and Beyond. Am J Clin Oncol. 2020;43(8):537-538. doi: 10.1097/COC.0000000000000725
- Leiser M. (2021, September 10). Biomarker testing decisions for lung cancer vary between academic, community oncologists. HemOncToday. Retrieved July 27, 2022, from https://www.healio.com/news/hematology-oncology/20210910/biomarker-testing-decisions-for-lung-cancer-vary-between-academic-community-oncologists
- Evans WD, Lantz PM, Mead K, Alvarez C, Snider J. Adherence to clinical preventive services guidelines: Population-based online randomized trial. SSM Popul Health. 2015;1:48-55. doi: 10.1016/j.ssmph.2015.11.003.
- Schillinger D. The Intersections Between Social Determinants of Health, Health Literacy, and Health Disparities. Stud Health Technol Inform. 2020;269:22-41. doi: 10.3233/SHTI200020
- Guerra CE, Fleury ME, Byatt LP, Lian T, Pierce L. Strategies to Advance Equity in Cancer Clinical Trials. American Society of Clinical Oncology Educational Book. 2022;42:127-137. doi: 10.1200/EDBK_350565
About The Author:
Omar Perez, Ph.D., has nearly 20 years of experience in designing, deploying, and leading high-visibility oncology initiatives supporting global companion diagnostic developments, strategic partnerships, and commercialization opportunities. Before joining AstraZeneca, he oversaw the global companion diagnostic (CDx) developments for GlaxoSmithKline’s oncology portfolio and led global CDx activities supporting numerous drug approvals for Pfizer. Notably, he led the first FDA-approved next-generation sequencing product for multiple targeted agents and helped establish the Center for Precision Medicine in Latin America to support Pfizer oncology products. Perez’s background includes roles in biotech and diagnostic companies, including cofounding Nodality, a diagnostic company focused on hematological malignancies. He is an inventor of the multiparametric phospho-proteomic flow technologies and an author of 37 publications and 35 patents.