Exact Sciences’ Tomasz Beer, MD, explains how multi-cancer early detection is moving out of research and into practice—bringing new clinical and operational considerations with it
Only four cancers have widely accepted screening tools today. That leaves two-thirds of diagnoses—and two-thirds of cancer deaths—tied to cancers that typically go undetected until late stages.
That disconnect is driving momentum around multi-cancer early detection (MCED), says Tomasz Beer, MD, chief medical officer at Exact Sciences. “I think the future of cancer screening will look different from today and we will look back with some disbelief that we only screened for four cancers,” he says.
In this conversation, Beer discusses how to begin implementing MCED in health systems now, how the Cancerguard® test—developed by Exact Sciences—uses a multi-biomarker class approach to improve early detection, and how the diagnostic workflow was designed to fit cleanly into existing care delivery.
Q: Dr. Beer, you’ve been involved in the clinical studies around multi-cancer early detection, also known as MCED. What are some key takeaways from that research that health leaders should know?
Beer: Let’s start with why this field exists and why there is so much interest in Multi-cancer early detection. Cancer is on its way to becoming the number one cause of death in the U.S. We know that effective screening tests that catch cancers earlier lead to more effective treatment that saves lives. We know this from studies on colorectal and lung cancer screening, among others. But today we only screen for four cancers: colorectal cancer, cervical cancer, breast cancer, and lung cancer, but only in smokers. And so MCED is really designed to complement standard-of-care screening and expand screening to many more cancer types, including those cancers we don't screen for today. That's why it's such a compelling opportunity.
We have a real-world evidence registry called Falcon, where we're enrolling up to 25,000 individuals who receive annual Cancerguard testing over three years. Our modeling studies suggest that if you were to deploy Cancerguard into a U.S. population aged 50 to 84 over a decade, we would see about a 42% reduction in stage-four metastatic cancer.
Q: Exact Sciences is the manufacturer of the Cancerguard® test, which uses a multi-biomarker approach. Can you explain what that means and why it’s important for catching cancers early?
Beer: Biomarkers are substances released by cancer cells into the bloodstream and are typically at very low concentrations, especially in earlier-stage cancers. They include things like DNA fragments, proteins, microvesicles, and other substances that come from cancer that are different from what you’d see in normal human cells. The challenge is that these signals are usually present in very low concentrations, especially in earlier-stage cancers.
The Cancerguard test includes two classes of biomarkers: an analysis of cancer-associated proteins and an analysis of tumor-associated DNA, specifically for unique methylation patterns that are particularly indicative of cancer. These were carefully selected and curated through extensive research and development, both in academic centers and within Exact Sciences, to identify a set of biomarkers that most clearly distinguish cancer from normal. We put those two classes of biomarkers together into a single blood test. A single algorithm combines all that data to determine whether cancer is suspected. We focused on multiple biomarker classes because cancers are not all the same. This approach gives us a better chance of catching more cancers early.
Q: What makes the Cancerguard test easy to implement in clinical workflows from a health systems perspective?
Beer: We’ve focused on making this test practical for both providers and systems. That starts with support. Providers receive clear materials explaining how to implement the test and have access to care navigation education and resources to support next steps after a positive Cancerguard test result. They also receive a phone call from our dedicated Care Navigation team after each positive result to help answer questions and provide available education and resources. We’ve also focused on creating a diagnostic resolution pathway that is simple, straightforward, and easy to implement with conventional screening tests.
With the Cancerguard test, the suggested approach to diagnostic resolution for a positive result starts with clinical evaluation, which may include common lab tests, and follow-up imaging using CT imaging of the neck to pelvis, and, if necessary, a PET scan. This is designed to be a straightforward workflow that a broad range of health systems can implement. Because this is a new technology, we have comprehensive support and education available at every step.
Q: Support is a big part of the equation–what kinds of support does Exact Sciences offer to help patients and providers navigate the process after a positive result?
Beer: We offer providers a library of information and resources to help educate providers on how the test works, how to interpret results, and what the diagnostic strategy might be. But more importantly, our Care Navigation team proactively calls each ordering clinician after a positive result. We want to make sure that they have the information they need to manage a positive Cancerguard result. If they’re comfortable, we will step back, but we’re there for as long as they need. For patients, we have a dedicated care navigation partner who can help them through the process, including if they have difficulty accessing care, have additional questions, or need some assistance finding an imaging center.
Q: How do you see multi-cancer early detection evolving over the next few years, and what should health systems be doing now to prepare for the future?
Beer: I think the future of cancer screening will look different from today and we will look back with some disbelief that we only screened for four cancers. As these tests become more widely available in the future, more broadly reimbursed, and continue to improve, we’d like to see a significant shift in cancer diagnoses toward earlier stages. When this happens, we are likely to see curative treatments for a larger proportion of patients with cancer, and hopefully, much better outcomes.
Already, academic health centers with specialty early-detection clinics are emerging. Their expertise will be in high demand in the future. Right now, these tests aren’t reimbursed by Medicare or most commercial plans. But that doesn’t mean health systems should wait. Health systems can prepare by beginning to deploy the technology. It's a good time to learn what implementation looks like in each system and to create diagnostic-resolution care pathways that are efficient and work well.
To learn more from Dr. Beer about why health systems are turning to Cancerguard for early cancer detection, listen to his podcast interview with HealthLeaders here.
Information presented is not clinical, diagnostic, or treatment advice for any particular patient. Providers should use their clinical judgement and experience when deciding how to diagnose or treat patients. Exact Sciences does not recommend or endorse any particular course of treatment or medical choice.