Expanding Early Detection of Hepatocellular Carcinoma With HelioLiver

Patients diagnosed with early-stage liver cancer have a significantly higher survival rate compared to those diagnosed in later stages, yet screening options and barriers persist. In the latest episode of Exploring AI in Oncology, Waqas Haque, MD, MPH, speaks with Bharat Tewarie, MD, MBA, the CEO of Helio Genomics, about the company’s AI-powered blood test, HelioLiver, and its potential role in detecting hepatocellular carcinoma (HCC), the most common form of liver cancer. Dr. Tewarie shares why liver cancer is a strong use case for blood-based early detection, how HelioLiver may fit into existing workflows, and barriers to overcome for broader adoption.

Unmet Needs in Liver Cancer Detection 

Dr. Tewarie emphasized that liver cancer represents a major unmet need in oncology because it is often diagnosed too late for curative treatment. “Liver cancer is emerging as a silent epidemic in the US, often going undetected because it’s diagnosed at an advanced stage due to having no early symptoms,” he said. 

He noted that the burden of disease continues to rise, with more than 42,000 new cases and nearly 30,000 deaths projected this year in the United States. “Today, the overall 5-year survival rate sits at just 22%,” he explained. 

Unlike some other cancers, HCC surveillance is already aimed at a clearly defined high-risk group, particularly patients with cirrhosis and hepatitis B infection. Still, Dr. Tewarie argued that current surveillance methods leave many patients behind. “Our current standard of care, imaging with ultrasound—a technology that is more than 40 years old, which you have to do every six months according to the guidelines—simply isn’t cutting it,” he said. “It suffers from poor patient adherence and suboptimal sensitivity,” with up to 90% of eligible adults forgoing recommended ultrasounds due to inconvenience, access, and other barriers. 

HelioLiver’s Place in Clinical Practice

When asked whether HelioLiver should be seen as a replacement for ultrasound or as an adjunct, Dr. Tewarie said the answer depends on clinical context. “Clinicians today should view HelioLiver as a very powerful tool that can serve in multiple roles depending on the clinical context,” he said. 

He drew a distinction between surveillance and diagnosis, stressing that the test does not replace definitive imaging. “While it doesn’t replace diagnostic contrast-enhanced MRI or CT, it does serve as a critical clinical trigger for these gold-standard modalities,” he said. In his view, HelioLiver may be particularly valuable in identifying smaller lesions earlier in the course of disease. “Ultrasound today misses every single sub-2 cm lesion in the real-world cirrhotic population,” he said. “HelioLiver, as we have shown in our CLiMB study, catches a meaningful portion of it.”

Dr. Tewarie added that the test can also function as a practical “safety net” for patients with inconsistent surveillance, inconclusive ultrasounds, or limited access to high-quality imaging. “A negative HelioLiver result provides an additional reassurance grounded in molecular signals, while a positive result prompts decisive next steps immediately, before any time is lost,” he said.

The Technology Behind the Test

Dr. Tewarie explained that HelioLiver identifies cell-free methylated DNA, which is a biomarker for cancer. The single-cancer focus, he argued, is a strength rather than a limitation. “Single-cancer early detection, like our HelioLiver test for HCC, holds clear advantages over a broader multicancer early detection panel, especially because of the high-risk, well-defined population,” he said.

Because the test is built specifically to detect liver cancer in cirrhotic patients, it is trained to interpret tumor signals in the setting of inflammation and fibrosis—two factors that complicate broad screening approaches. “Single-cancer detection like with HelioLiver can excel by delivering better sensitivity for the smallest curable liver tumors in high-risk patients,” he said.

What to Do After a Positive Test

Dr. Tewarie said that HelioLiver can be integrated into current HCC workflows without requiring a completely new pathway. “If HelioLiver shows positivity, you go to the next step in the guideline, which is MRI,” he said. “Therefore, with a single-cancer early detection like HelioLiver, you can still stay in the existing workflow, which is very important for a practice.”

He also discussed the company’s partnership with Quest Diagnostics, which is intended to make adoption easier for clinicians. “A Quest provider client is now able to directly access HelioLiver through the existing Quest account and electronic health records. This collaboration removes logistical hurdles for clinic staff and facilitates routine integration of the test into patient blood work, which is essential for long-term workflow integration.” he explained, adding that the partnership helps shift the test “from a manual kit-based process to seamless laboratory workflow.”

Patients Who May Benefit Most 

Based on prospective clinical trial data, Dr. Tewarie said the test appears broadly applicable across etiologies of cirrhosis, with particular value in populations for whom ultrasound is less reliable. “HelioLiver delivers its greatest impact precisely where it’s needed most—patients with cirrhosis and hepatitis B infection ” he said.

Clinician Education

Although reimbursement and workflow integration remain important, Dr. Tewarie identified clinician education as the greatest near-term challenge. “The biggest challenge today is clinician education,” he said, particularly among hepatologists, gastroenterologists, and primary care clinicians managing patients with cirrhosis, MASLD, metabolic dysfunction–associated steatohepatitis (MASH), or hepatitis B.

He argued that many clinicians still default to imaging because it is familiar, even when its limitations are well known. “Blood tests like HelioLiver actually represent a paradigm shift,” he said. “Objective, convenient, and superior for smaller tumors, especially those less than 2 cm.”

Advice for Clinicians Interested in Health Tech 

To conclude, Dr. Tewarie offered reflections on leadership and the evolving role of the clinician-innovator in an era of rapid technological change. Drawing on both his background and his history in the biopharmaceutical industry, he urged his colleagues to remain open to evidence-backed tools that solve practical clinical problems.

“My strongest advice for clinicians and oncologists is to embrace technologies that genuinely can move the needle in early detection, but also to demand rigorous disease-specific evidence before you integrate them into practice,” he advised. He emphasized that true leadership requires the courage to move towards proactive, modern upgrades that address systemic barriers like patient access and operator dependency. “Leadership means staying curious and staying open to innovation,” Dr. Tewarie said, concluding that the ultimate goal of adopting these advancements is to “turn surveillance from a routine to something that never loses sight of what truly benefits the patient in front of you.”

Key Takeaways

• Liver cancer remains a major unmet need because many patients are diagnosed at advanced stages, when curative options are limited.

• HelioLiver is a blood-based test that detects cell-free methylated DNA and is designed specifically for early HCC detection in high-risk patients.

• Dr. Tewarie described the test as an adjunct, replacement, or safety net to surveillance with ultrasound depending on clinical context—not a substitute for diagnostic MRI or CT.

• A positive HelioLiver result should prompt the next step in the guideline-based workflow, namely diagnostic MRI.

• The test may be especially useful in patients with cirrhosis and hepatitis B infection and patients who are nonadherent with ultrasound surveillance.

• According to Dr. Tewarie, the largest barrier to adoption is not technology, but clinicians’ education.

About the Speakers

Bharat Tewarie, MD, MBA, serves as the CEO of Helio Genomics, leveraging his medical and business expertise to drive strategic growth. With decades of global healthcare leadership, he possesses a deep understanding of commercial, operational, and scientific processes essential for scaling innovative platforms and deploying them worldwide. Dr. Tewarie is committed to advancing the integration of AI and data science within in global healthcare. 

Waqas Haque, MD, MPH, is a second-year Hematology/Oncology Fellow at the University of Chicago. He recently completed his Internal Medicine Residency at New York University (NYU) in a Clinical Investigator Track. Dr. Haque has balanced his patient care work with a variety of research projects. During his fellowship training at the University of Chicago, he plans to further his work in innovative clinical trial design, value-based care delivery to cancer patients, and clinical investigation.