Exact Sciences reported that its Oncoguard Liver blood test achieved a 67 % sensitivity for very early‑stage hepatocellular carcinoma (HCC) and an 82 % specificity, outperforming the current standard of care ultrasound, which detected only 22 % of cancers defined by the Milan criteria. The test’s performance was demonstrated in the ALTUS study, the largest prospective, real‑world trial of a blood‑based liver cancer surveillance test in the United States, enrolling more than 3,000 high‑risk patients across community practices, Veterans Affairs sites, and academic centers.
The ALTUS study showed that Oncoguard Liver detected three times as many early‑stage cancers as ultrasound, translating into a seven‑fold improvement in early‑stage detection. The test was developed in partnership with Mayo Clinic and combines DNA methylation and protein markers in a multi‑omics assay. The data will be presented at the American Association for the Study of Liver Diseases (AASLD) meeting on November 11, 2025, and Exact Sciences plans to submit the findings for publication in a peer‑reviewed journal and pursue regulatory pathways to broaden clinical adoption.
Exact Sciences’ Q3 2025 financial results underscore the company’s capacity to support this new product launch. Total revenue rose 20 % year‑over‑year to $851 million, driven by a 22 % increase in Screening revenue ($666 million) and a 13 % rise in Precision Oncology revenue ($184 million). Net loss narrowed to $20 million from $38 million a year earlier, and the company raised its full‑year revenue and adjusted EBITDA guidance, reflecting confidence in sustained growth and margin expansion.
CEO Kevin Conroy emphasized that the Oncoguard Liver data reinforce Exact Sciences’ mission to eradicate cancer through earlier detection. “Our third‑quarter results reflect the power of our patient‑centric platform and trusted brands, and the momentum we are building is fueling growth and advancing innovative new tests like Oncoguard Liver,” Conroy said. CFO Aaron Bloomer added that the company is well positioned to achieve its 2027 financial targets, citing disciplined cost management and a strong pipeline.
The Oncoguard Liver test is currently a CLIA‑certified laboratory‑developed test (LDT) performed at Genomic Health, Inc., and has not yet received FDA clearance. The company’s next steps include publishing the ALTUS data, engaging with regulatory authorities, and expanding clinical adoption through payor coverage and provider education. If approved, the test could become a non‑invasive, more sensitive alternative to ultrasound, potentially shifting the standard of care for liver cancer surveillance and expanding Exact Sciences’ revenue base in the oncology diagnostics market.
The combination of robust clinical performance, strong financial momentum, and a clear regulatory roadmap positions Exact Sciences to capture a significant share of the growing liver cancer screening market. The company’s established track record with Cologuard and Oncotype DX, coupled with the promising early‑stage detection rates of Oncoguard Liver, suggests a compelling opportunity for long‑term growth in both screening and precision oncology segments.
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