A conversation with Bharat Tewarie, M.D., MBA, CEO of Helio Genomics

When 80% to 90% of at-risk patients are missing recommended surveillance, that's not a marginal gap, it's a systemic failure. In your view, what's the primary driver of that breakdown? Is it the limitations of ultrasound itself, the clinical workflow required to get patients into an imaging suite, or something more fundamental about how liver cancer risk is perceived by patients and providers?

When I today reflect on hepatocellular carcinoma (HCC),the deadliest form of liver cancer, I’m struck by a troubling paradox. We know exactly who is at risk: patients with cirrhosis or chronic hepatitis B. These individuals are already enrolled in surveillance programs, with clear guidelines recommending screenings with ultrasound, a 45-year-old technology,every six months. Yet despite the existence of this well-established, biannual protocol in current guidelines, reality tells a different story. The vast majority — between 80% and 90% — never actually make it to their scheduled ultrasound appointments.

The reasons are multifaceted. It’s not that patients reject surveillance. They they’= are deterred by the logistical challenges of arranging separate ultrasound visits, the burden of scheduling, transportation issues and the disruption caused by missing work. On top of that, the effectiveness of ultrasound depends heavily on the skill of the technician, introducing variability that undermines consistent detection.

As a result, liver cancer is often discovered far too late , by stage 3, where survival averages 18 months. We’re not losing to cancer itself; we’re losing because we’re missing opportunity for an earlier diagnosis. Blood-based tests like HelioLiver offer a solution, eliminating these barriers and streamlining the screening process.

Liver cancer is somewhat unusual in that we actually know who the high-risk population is, patients with cirrhosis, chronic hepatitis B, advancing MASH [metabolic dysfunction-associaated steatohepatitis], The screening infrastructure exists in AASLD [American Association for the Study of Liver Disease] guidelines. Yet adherence remains dismal. Does the fact that we can clearly define the at-risk population but still can't get them screened make liver cancer a uniquely instructive model for what blood-based detection could solve across oncology?

I would say resoundingly yes.

Liver cancer is actually the perfect proof-of-concept for blood-based detection for many reasons: First there is a massive unmet need. Liver cancer is emerging as a silent epidemic in the U.S., often going undetected until advanced stages due to the absence of early symptoms. The overall 5-year survival rate sits at just 22%, largely because most patients are diagnosed late, when curative options are off the table. But catch it early, localized and resectable or transplant-eligible and the five-year survival rate soars to 70%. Secondly there is a clearly defined screening population at risk. And lastly our current standard of care, which is imaging with, ultrasound every six months plus AFP [alpha-fetoprotein], simply isn’t cutting it as it suffers from poor patient adherence and suboptimal sensitivity for early-stage disease.

Blood-based testing, such as HelioLiver, addresses these gaps by offering a simpler, more accessible collection method that can be performed at any phlebotomy location during a routine check-up. With Helio Liver, patients can have the blood test done right in the office, which is much more convenient. This convenience already enables earlier detection of liver cancer. Additionally HelioLiver has demonstrated superior performance compared to ultrasound in our head-to-head study, particularly when it comes to identifying very small liver cancers .

Could a medical assistant or an allied health professional administer the test?

Yes. A major barrier to effective surveillance is that patients are frequently referred to outside facilities for ultrasounds, leading many to postpone or skip the procedure altogether. In some cases, they never undergo the ultrasound at all, resulting in missed opportunities for early detection. This is the heart of the compliance issue. What’s crucial to understand is that Helio Liver requires a simple blood draw. With HelioLiver It is not just about finding more cases—it’s about finding them sooner, at stage 1, when liver cancer is still curable and a patient’s prognosis can be dramatically improved.

You've described the challenge of getting innovative diagnostics into routine practice as a "last mile" problem. Can you unpack that? Once a test has strong clinical data behind it, where specifically does adoption stall? Is it physician awareness, reimbursement uncertainty, patient engagement or something about how diagnostics fit into existing care workflows?

When discussing the “last mile” of commercialization, it’s crucial to focus on several key aspects that underpin this.

Beyond having a highly precise test and a well-defined patient population, we must prioritize enhancing physician awareness and experience and actually reaching them. In our case, the target audience is smaller than in broader indications like colorectal cancer — approximately 7,000 to 8,000 specialists, making it a well-defined and manageable market.

Equally important is optimizing workflows within the practices responsible for implementing prescriptions, particularly through integration with IT systems. Additionally, patients expect a positive experience, which includes convenient access to blood draw centers, minimizing travel and streamlining their care. To address these needs, Helio has adopted a capital-efficient, partnership-led approach during the early stages of launch.

Our recent partnership with Quest Diagnostics exemplifies this strategy, enabling Helio Genomics to leverage Quest’s extensive network to reach more patients and care teams. Quest’s provider clients can now directly access HelioLiver through their existing Quest accounts and electronic health records , utilizing Quest’s approximately 7,700 patient service centers and in-office phlebotomists across the U.S. 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.

What have you learned about other precision diagnostics companies?

Everyone is doing a phenomenal job and contributing toward ensuring patients receive the care they deserve. But everybody does it in different ways. My first step is to learn who is doing what and to recognize their unique contributions, even as we forge our own path with what we call single early cancer diagnostics, highly precise tools designed for a very specific target audience. The market isn't just about competition; it's also about collaboration with stakeholders. Often, working together can yield greater benefits for patients and the field as a whole.

Do you foresee partnerships with any pharmaceutical companies and their therapies targeting specific types of liver cancer?

Yes, definitely. I'm seeing more and more partnerships take shape in this space. The companies that thrive will be those who recognize the power of collaboration early, where one plus one truly equals four.

Our platform also presents opportunities to help pharmaceutical companies develop therapies more efficiently. Our blood-based test can serve as a biomarker to determine whether a new liver cancer drug is effective. As a result, companies are now approaching us to access our expertise, platform, algorithms, intellectual property and the extensive data we have compiled.

I also would encourage any health insurance provider to reach out and join us in launching a genuine public health initiative for early cancer screening for patients at risk. Together, we could address underserved areas, collaborate on surveillance testing, and collect real-world data.

The MCED [multicancer early detection] conversation has been dominated by pan-cancer screening tests from companies like GRAIL and Exact Sciences. As a CEO coming from the pharma side, where indication-specific development is the norm, how do you think about the strategic logic of a single-cancer test like HelioLiver in an MCED world that seems to be betting on breadth?

MCED has its place, especially when targeting large populations. However, our test is designed for a very specific group. When you’re dealing with populations like those with cirrhosis or hepatitis B, it’s much more effective to focus on early detection for a single cancer. Why? Because if you know someone has a disease that puts them at higher risk, in this case, liver cancer, you want to ensure they don’t have it, which requires the most sensitive test possible.

Each test serves its own market. For the defined population we target, such as cirrhotic patients, a single cancer early detection test is more suitable and appropriate. Today, single-cancer detection like HelioLiver excels by delivering better sensitivity for the smallest, curable liver tumors in high-risk patients, turning a silent killer into a treatable condition.

I think you've signaled interest in other types of cancer. Do you feel that the multianalyte, AI-driven approach might get easier with each cancer?

The more data we collect, the greater our ability to train our algorithms, which serve as the foundation for new developments we’re initiating. The first next step is a test to monitor the treatment effect of liver cancer drugs.

Another key area will be focusing on recurrence of liver cancer after a liver transplant. This approach allows us to build a robust liver cancer test franchise with relatively little additional effort. Strategically, the next question becomes: Who is our target audience, and which other cancers can we address for this same group? Right now, we're being practical, evaluating what we have, and determining what additional tests we can develop for the audience we already serve.

In the ENCORE study, 10 of the 28 genes in the HelioLiver test were found to be directly involved in molecular pathways implicated in HCC, compared to just 1 of 497 unselected genes meeting the same criteria. That suggests the AI isn't just finding statistical correlations. It's identifying biologically meaningful signals. How important is that biological interpretability for gaining clinician trust, and ultimately, payer confidence?

It is very important. The combination of technology with a deep understanding of biology and disease provides a distinct advantage in this field. You need expertise in all these areas. This is what sets Helio apart from pure technology companies: our ability to integrate these disciplines enables us to develop tests that truly improve patient outcomes.

When considering AI in biotech, or technology in biology, we've evolved from what was once a niche research tool into something that continues to decode biological complexity. With this understanding, we can accelerate not only discovery, but also diagnostics and precision care. Today’s stakeholders are focused on platforms with proven clinical utility, not technology for research’s sake, but solutions that make a tangible difference in clinical settings and improve patient care.

A forward-looking question: Three to five years from now your approach has succeeded, liver cancer outcomes have meaningfully improved. What does that prove for the broader early detection field. And then the other part of the question is, what's the lesson that other tumor types and payers evaluating them should take from liver cancer as a test case?

It's crucial to detect cancer as early as possible. Early detection benefits not only patients and their families, but it also significantly reduces costs for society as catching cancer in its initial stages is far more cost-effective..

HelioLiver is bringing us closer to making this early, curative detection the rule rather than the exception. HelioLiver is not just about catching more cases; it’s about catching them while we can still make a difference.