Cancer will claim an estimated 618,000 lives in the U.S. in 2025, according to the American Cancer Society. Yet, despite advances in treatment, most of these deaths stem from cancers without guideline- recommended screening tests.
Multi-cancer early detection (MCED) screening has the potential to change how and when cancer is diagnosed, with tremendous potential to detect cancers much earlier and improve mortality.
To learn more about the promise of MCED, the Becker’s Healthcare Podcast spoke with Tom Beer, MD, vice president and chief medical officer for MCED at Exact Sciences. Dr. Beer is a medical oncologist with years of experience treating cancer patients and conducting clinical trials.
Cancer detection today
Today, the CDC supports screening for breast, cervical, colorectal and lung cancers, as recommended by the U.S. Preventive Services Task Force.
However, these four cancers represent only about one-third of cancer diagnoses and deaths. The other two-thirds of cancers are not routinely screened for. “We don’t look for them proactively, and we only diagnose them when they become clinically apparent,” Dr. Beer said.
But when cancer is only diagnosed and treated after it becomes apparent — at later stages of the disease — treatments are less effective and survival rates are lower.
New hope in the fight against cancer
The drive toward MCED is rooted in a core belief shared across oncology: earlier is better. As Dr. Beer put it: “We know that earlier detection through screening saves lives, and that’s really our best hope in the fight against cancer.”
MCED is a blood-based screening test designed to identify multiple cancers at once. The goal is simple but powerful — detect cancers sooner, when treatment is far more likely to be effective.
The simplicity of a blood draw makes MCED uniquely scalable. While current screening protocols address only four cancer types, adding an MCED test could extend screening to most cancers people are at risk for, dramatically expanding the reach of early detection.
Clinically-led implementation of MCED
As health system leaders gain a deeper understanding of MCED and consider how to put it into practice, Dr. Beer highlighted several key considerations.
First is selecting the right test for your health system, based on the features. Exact Sciences’ MCED test, Cancerguard™, is unique in that it is constructed on a multi-biomarker class platform that analyzes circulating DNA and proteins in the bloodstream. “We believe this approach gives us more shots on goal to detect cancers,” Dr. Beer said.
Exact Sciences is also focused on maximizing the early-stage sensitivity of MCED tests. The goal is to detect cancers at the earliest stages, which provides the greatest opportunities for successful treatment and favorable health outcomes. “Detecting a broad range of cancers at the earliest possible stages is a key feature,” Dr. Beer said.
Equally important is how screening tests are implemented and followed up throughout a patient’s diagnostic journey. MCED tests are designed for screening, not diagnosis: they indicate whether a cancer signal was detected or not, which may warrant additional clinical evaluation and diagnostic testing. To support this next step, Exact Sciences has developed a streamlined, reproducible diagnostic pathway to help clinicians get patients answers that are clear and actionable.
“Understanding the role of the screening test and the execution of the evaluation pathway that follows a test is critically important for successful implementation,” Dr. Beer said.
Beyond the screening test, effective MCED implementation must involve robust provider education, since this is a new class of tests that is unfamiliar to many clinicians.
Proactively integrating MCED screening into workflows and the EHR is also essential. Just as clinicians remind patients not to skip their colonoscopy or other routine screening, it is important to embed MCED screening into clinicians’ routine processes so it becomes a standard practice.
“It’s not just about a test,” Dr. Beer said. “It’s about how it is delivered in the clinic and what the patient experience is like.”
Evaluating long-term potential of MCED
The healthcare outcome modeling group at Exact Sciences has modeled the potential impact of introducing an annual MCED screening test. According to this analysis, over a 10-year period, there could be a 42% reduction in stage 4 metastatic cancer, across all cancer types in the population.
At the same time, there would be some corresponding increases in the diagnosis of stage 1, 2 and 3 cancers. But this large shift away from more advanced disease was projected to reduce all-cancer mortality in the population by about 18%.
Dr. Beer underscored these are modeling results, which will need to be confirmed over time with testing and long-term follow-up. But these results indicate the potential of MCED screening to change the fight against cancer.
“I expect a dramatic shift in how cancers are diagnosed and treated as we shift diagnosis from later stages to earlier stages of disease, where treatments can be more effective, less costly and cause fewer side effects,” Dr. Beer said.
1 Important Information about the Cancerguard Test
Rx only.
The Cancerguard™ test is indicated for use in adults ages 50-84 with no known cancer diagnosis in the last three years. It detects alterations in circulating tumor DNA and tumor-associated protein levels which are commonly associated with cancer. The test does not detect all cancers and is not a replacement for existing recommended cancer screening or diagnostic modalities for cancer. Current recommended screening for cancer should also be followed. The test is not indicated for screening of breast and prostate cancer and was not evaluated for the detection of pre-cancerous lesions. Due to the potential for follow-up imaging with IV contrast CT after a positive test result, careful consideration should be given before ordering the Cancerguard test for patients with a history of adverse reactions to iodine based IV contrast or for women who are, may be, or plan to become pregnant.
Results should be interpreted in the context of a patient’s medical history, clinical signs, and symptoms. A negative result does not rule out the presence of cancer of any type. A positive Cancerguard™ test result means that the blood test identified a cancer signal that may indicate the presence of cancer. This result alone does not confirm the presence of cancer. Further clinical evaluation by a healthcare provider (which may include blood tests such as complete blood count and comprehensive metabolic panel) and follow-up imaging are needed to locate and confirm a diagnosis of cancer or determine that cancer is not present. While there are no established guidelines for imaging following a positive Cancerguard test result, there is a published follow-up workflow based on expert clinician opinion and results from an exploratory, prospective, interventional study [Kisiel et al Life (Basel) 2024 Jul 24; Lennon et al, Science, 2020]. The proposed workflow in the Kisiel et al publication includes an intravenous-contrast enhanced computed tomography (IV contrast CT of chest, abdomen/pelvis, and soft-tissue neck) and if necessary, positron emission tomography-computed tomography (18F FDG PET-CT) from the skull-base to mid-thigh. Alternative follow-up procedures (e.g. targeted imaging, endoscopic procedures, CT without IV- contrast) may be appropriate in the context of the patient’s medical history and clinical evaluation [Lennon et al, Science, 2020]. False positive and false negative test results can occur.
The Cancerguard test was developed, and the performance characteristics validated by Exact Sciences Laboratories following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. This test has not been cleared or approved by the US Food and Drug Administration. The test is performed at Exact Sciences Laboratories. Exact Sciences Laboratories is accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing.
Information provided is not intended as medical advice, and should not replace professional medical treatment.
Exact Sciences and Cancerguard are trademarks of Exact Sciences Corporation.
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