AI Blood Test for Liver Cancer Gains Massive Reach via Quest Deal

IRVINE, Calif. – March 18, 2026 – In a significant move to combat one of the fastest-growing causes of cancer-related deaths in the U.S., Helio Genomics today announced a major agreement with Quest Diagnostics. The partnership will make HelioLiver™, an innovative, AI-powered blood test for the early detection of liver cancer, widely available to healthcare providers through Quest's extensive national network. Starting in April, physicians across the country will be able to order the test, a development that could fundamentally change how at-risk patients are monitored for this deadly disease.

A New Weapon Against a Silent Epidemic

Liver cancer, particularly hepatocellular carcinoma (HCC), has become a pressing public health crisis in the United States. Often described as a 'silent epidemic,' its incidence rates have tripled since 1980, with mortality rates doubling in the same period. The disease typically presents no symptoms in its early stages, meaning diagnoses often occur when the cancer is advanced and treatment options are limited and less effective.

This diagnostic delay has dire consequences. However, when liver cancer is caught early, the prognosis shifts dramatically, with the five-year survival rate soaring to 70 percent. The challenge has always been effective and consistent surveillance. Current guidelines from the American Association for the Study of Liver Diseases (AASLD) recommend that high-risk individuals—including those with liver cirrhosis from hepatitis B or C, alcohol use, or fatty liver disease—undergo screening every six months. Yet, adherence to this recommendation is alarmingly low.

Overcoming the Barriers of Traditional Screening

The current standard of care for liver cancer surveillance primarily involves an abdominal ultrasound, sometimes paired with an alpha-fetoprotein (AFP) blood test. While established, this approach is fraught with challenges. Studies show that a staggering 80 to 90 percent of eligible patients skip or do not receive their recommended biannual ultrasounds. Barriers include the inconvenience of scheduling separate imaging appointments, access issues, and the performance limitations of the technology itself.

Ultrasound's effectiveness is highly dependent on the skill of the operator and can be hampered by patient-specific factors. More critically, its sensitivity for detecting small, early-stage tumors is a known weakness. Research has shown that ultrasound can miss a significant number of early lesions, delaying a potential life-saving diagnosis.

This is the critical gap HelioLiver™ is designed to fill. By requiring only a simple blood draw, it can be integrated into a patient's routine check-up, removing the logistical hurdles that plague ultrasound adherence. The goal is to provide a more convenient and sensitive tool that encourages regular screening and ultimately catches cancer earlier.

The Science of AI-Powered Detection

HelioLiver™ represents a significant leap forward in diagnostic technology. It is not a simple biomarker test but a sophisticated multi-analyte platform that leverages the power of artificial intelligence. The test analyzes a combination of cell-free DNA (cfDNA) methylation patterns, protein biomarkers, and patient demographics. A proprietary AI algorithm then integrates these data points to detect a biological signature associated with the presence of HCC.

This multi-faceted approach has demonstrated impressive results in clinical trials. The landmark CLiMB study, a prospective, blinded, multicenter trial in the U.S., showed that HelioLiver™ outperformed traditional ultrasound in identifying HCC. The test demonstrated a sensitivity of 76% for detecting early-stage (I and II) HCC, significantly higher than the 47% sensitivity shown by ultrasound in a similar high-risk population. In the CLiMB trial, HelioLiver detected 28.6% of tumors smaller than 2cm, whereas ultrasound failed to detect any lesions of that size.

"This agreement with Quest Diagnostics is an important step in our mission to democratize early cancer detection," said Dr. Bharat Tewarie, CEO of Helio Genomics, in a statement. "By harnessing Quest's vast scale and infrastructure, our goal is to expand access to tools that physicians can use to aid detection of liver cancer at its most treatable stage."

Currently available as a Laboratory Developed Test (LDT) performed at Helio's CLIA-certified laboratory, the company has also submitted for full Premarket Approval (PMA) from the FDA, signaling its confidence in the test's clinical robustness.

Quest's Scale Unlocks Nationwide Access

The strategic importance of the partnership with Quest Diagnostics cannot be overstated. While Helio Genomics developed the cutting-edge science, Quest provides the massive logistical engine required to bring it to the masses. Quest serves approximately half of all physicians and hospitals in the United States and operates a network of nearly 7,700 patient service centers.

Beginning in April, any healthcare provider with a Quest account can order HelioLiver™ directly, often through existing Electronic Health Record (EHR) system integrations. This seamless workflow removes adoption barriers for physicians and allows patients to have their blood drawn at a convenient location, often during the same visit as other routine lab work. Helio will continue to perform the analysis at its specialized lab in Indiana, with results returned to the provider through Quest's system.

"Liver cancer represents a growing public health imperative, and our collaboration with Helio Genomics underscores our belief in the potential of liquid biopsy to aid early detection of cancer," said Asia Chang, vice president and general manager of Oncology at Quest Diagnostics. "Through this arrangement, Helio Genomics will be able to use Quest's scale to reach more patients and their care teams."

This collaboration reflects a broader strategy for Quest, which has been actively expanding its advanced diagnostics portfolio, particularly in oncology and liquid biopsy. By incorporating HelioLiver™, Quest strengthens its offerings and solidifies its role as a key player in the next generation of cancer care.

The widespread availability of a more sensitive and accessible blood test has the potential to transform liver cancer surveillance. For millions of at-risk Americans, regular screening could become a simple, manageable part of their healthcare routine rather than an easily deferred inconvenience. By detecting the disease at a molecular level, potentially even before it is visible on an ultrasound, this technology offers new hope in the fight against a silent killer, aiming to redefine survivorship by making early detection the norm, not the exception.