Tag: Biomarker

The video starts simply: a couple at home, music playing, dogs in the background. Allison Barry smiles as she talks about the rhythms of her life with her husband Chris, how they’ve built a life together that’s carefully planned, structured, and anchored around work and the future. Vacations could be put off. Retirement would be the time to explore.

Barry loved her job. As senior director of portfolio communications at Exact Sciences, she was deeply involved with the launch of Cancerguard, a new multi-cancer early detection (MCED) test. The day that Cancerguard became available, September 10, 2025, would be a day to remember. “We were in New York at the New York Stock Exchange, and [the announcement of Cancerguard] was on the big billboard,” said Barry in the video released by Exact Sciences a month ago. “It was one of the proudest moments of my entire life.”

But that wasn’t the only notable event of the day. Barry did one other thing—she ordered the Cancerguard test, expecting a negative result. Then the tone in the video shifts. Barry’s test was positive. “She was the very first positive result,” Tom Beer, MD, then chief medical officer (CMO) at Exact Sciences, told me as we watched the video about Barry’s experience with Cancerguard. “She literally ordered it the first day.”

What follows is a blur of scans, fear, and uncertainty until doctors find a tumor the size of a football (22 cm). The diagnosis: stage-one mucinous ovarian cancer, a disease that is almost always caught too late. Surgery follows. The outcome is positive. That all happened in the span of six months. Today, Barry is cancer-free.

A test for unscreened cancers

Beer and the team at Exact Sciences have spent years designing Cancerguard, named in the same vein as the company’s flagship product Cologuard, to identify cancers that currently lack effective screening options and to catch them earlier, when treatment is more likely to succeed.

Cancerguard is a multi-biomarker MCED classifier that combines two types of biological signals: cell-free DNA (cfDNA) methylation and protein biomarkers. Each is analyzed separately, then integrated into a single result. If either signal is positive, the test flags a potential cancer. “They’re complementary sources of information,” Beer explained.

Beer’s colleague Frank Dielh, PhD, presented new data during the AACR 2026 conference showing that the multi-biomarker MCED approach used in the Cancerguard test improves cancer detection across stages by combining these two signals, with each set of biomarkers contributing independently to overall performance.

The prospective case-control study of 3,163 participants showed detection was driven by cfDNA methylation alone in 47.1% of cases, protein alone in 7.4%, and both in 45.5%, with no false positives showing both markers, underscoring the value of a multi-signal approach for earlier and broader detection.

But what’s most valuable, according to Beer, is the stages that the combined scores provide. Across a broad range of cancers, sensitivity increases from about 24% in stage one to 90% in stage four. While those early-stage numbers may seem modest at first glance, Beer emphasized the context. “We’ve been really focused on early-stage sensitivity as our North Star,” said Beer. “We’re screening for cancers that currently have zero effective screening. So, even incremental sensitivity is meaningful.”

By layering different biological signals, the test builds a more complete picture: one that is particularly valuable when tumors are small and harder to detect.

Going global and human impact

In November 2025, a couple months after Cancerguard launched, Exact Sciences made a deal to be acquired by Abbott, a major bet for the medical device and healthcare company on cancer diagnostics. While the technology for Cologuard and Cancerguard was already in development at Exact, the scale of deployment changes dramatically with access to a global healthcare network. “Abbott has a truly global presence,” Beer said. “Relationships with health systems and governments around the world. That changes how we think about opportunity.” An ongoing study in Japan reflects that shift.

On December 11, 2025, Exact Sciences launched the CRANE (Cancer Recognition and Assessment through Non-invasive Evaluation) Study in Japan—a large, multi-center trial enrolling about 2,000 participants—to evaluate the sensitivity and specificity of Cancerguard test across different cancer types and stages. “If you’re going to build something for global use, you need to understand how it behaves globally,” he said. “Geography and ethnicity could influence performance.”

Designing a cancer screening test isn’t just about detecting as many cases as possible. It’s about balance, particularly between sensitivity and specificity. Internally, Beer explains, the team models outcomes in terms of life-years gained versus the risks and costs of false positives. These trade-offs determine where thresholds are set within the algorithm. “We’re not just picking a random cutoff,” he said. “We’re thinking deeply about how to deliver the greatest public health impact.”

These internal models, though not publicly shared, guide every stage of development. The goal is not just accuracy but meaningful outcomes, catching cancers early without overwhelming patients and healthcare systems with unnecessary follow-ups.

For all the technical detail, our conversation keeps returning to people. Beer recalls another friend who retired at 65, only to be diagnosed with advanced pancreatic cancer six months later. He didn’t survive.

Placed alongside Barry’s story, the contrast is stark. One life was altered by early detection; the other never got the chance to do anything about it. What makes Barry’s story powerful is not just its outcome but also its implication, which is that cases of cancer can be caught early enough to change everything. The ultimate goal for Beer is to make such stories routine.

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