Helio AI Liver Tests Outdo Ultrasounds

Cancer diagnostics firm Helio Genomics says its five-year clinical trial shows its AI-based diagnostic test is two to four times more effective than typical ultrasounds.

Helio’s pivotal trial, which it calls Clinical Trial Multi-analyte Blood Test (Climb), found that its flagship product, HelioLiver, outperformed ultrasounds in detecting early-stage liver cancer out of 2,000 patients.

“It’s the first and largest study of its kind in liver cancer,” co-founder and Chief Executive Justin Li told the Business Journal.

Helio submitted the product to the Food and Drug Administration last month and expects to get approval by the second quarter of next year, according to Li.

Helio, which has raised more than $180 million to date and is looking for further financing, is attracting national attention. Earlier this year, Robert Langer, the co-founder of Moderna, the Cambridge, Mass.-based biotech company that developed an mRNA vaccine for COVID-19, joined Helio’s scientific advisory board.

“He has seen the data from our clinical trial and thinks that it’s a game changer,” Li said.
Helio, based in Irvine, today is scheduled to hold an investor day at Nasdaq headquarters in New York to review results from its clinical trial, as well as provide a company update to its investors.

The company didn’t disclose further details about its effort to raise more funds, but Li said that Helio is having “informal conversations with institutional investors.”

AI-Based Test

Helio is one of several Orange County companies leveraging artificial intelligence in healthcare, including Children’s Hospital of Orange County, City of Hope and Medtronic.

The company is one of the earliest pioneers to use technology that analyzes methylation, or gene regulators, for cancer detection. Helio’s diagnostic test uses AI to detect and predict liver cancer in people who are at high-risk due to having liver cirrhosis.

HelioLiver has an algorithm that identifies the best biomarkers to test for.

“What we’re doing is looking at methylation patterns,” Li said. “So not necessarily just the markers themselves, but also the ratio and variation of certain markers.”

Helio was awarded best in AI-based medical technology from the California Investment Forum, an event that kicked off for the first time this year.

On June 8, the company presented results of its Climb trial at the 2024 European Association for the Study of the Liver Congress, which was held in Milan.

“Data from the Climb study demonstrate that the HelioLiver Dx test is not only more sensitive than ultrasound at detecting HCC lesions overall, but also detects more early stage and small lesions in a diverse cohort of patients with liver cirrhosis,” said Dr. Richard A. Van Etten, director of the Chao Family Comprehensive Cancer Center at the University of California, Irvine.

“HelioLiver Dx has significant promise to redefine the standard of care with a convenient, and accurate, blood-based test, through both improved early detection as well as increase in testing adherence, thereby reducing HCC morbidity and mortality,” he said.

The results, according to the company, were as follows for detecting hepatocellular carcinoma (HCC), or liver cancer, in patients with cirrhosis.

– All HCC lesions: 48% for HelioLiver Dx vs. 28% for ultrasound.
– HCC lesions ≤ 4 cm: 38% for HelioLiver Dx vs. 14% for ultrasound.
– HCC lesions < 2 cm: 29% for HelioLiver Dx vs. 0% for ultrasound. Notably, ultrasound failed to detect any lesions < 2 cm in the Climb study, the company said.
– T1 HCC lesions: 44% for HelioLiver Dx vs. 11% for ultrasound.

Investor Day

Li won the Business Journal’s Innovator of the Year Award in 2022 for launching the liver cancer test in partnership with Fulgent Genetics Inc., an El Monte-based cancer researcher with a $610 million market cap (Nasdaq: FLGT).

He was motivated to develop early-stage cancer tests due to his grandfather dying from lung cancer. China’s equivalent of the FDA last July approved a liver cancer detection test from Helio’s sister company, Laboratory for Advanced Medicine & Health Group.

Helio in February hired Gary Frazier as its chief growth officer in preparation for the commercialization of HelioLiver.

Frazier will help roll out HelioLiver in pilot programs across healthcare companies and organizations in California ahead of FDA approval.

“We’ll be signing up individual physicians and try to get them to use our test,” Li said.

Helio has 35 full-time employees at its Irvine headquarters and plans to hire more within its sales and customer service departments.

The company is also looking to expand its product line, which will take more time and capital to accomplish, Li said.

Upcoming products will relate to minimal residual disease and treatment monitoring for liver cancer.

“We’re going to stay in liver cancer for the next two products, but we’re also looking at other types of cancers,” Li said.