A version of Helio Genomics’ liver cancer test this month got the green light from China’s equivalent of the Food and Drug Administration.
The Irvine-based cancer diagnostics firm, which is one of the better-funded medtech companies in Orange County, said that the liver cancer detection test from its sister company, Laboratory for Advanced Medicine & Health Group (LAMH), received approval from China’s National Medical Products Administration.
The approved product is a variation of the local company’s HelioLiver test, though it was developed with the same intellectual property portfolio as Helio.
“Because the IP stems from the same place and because China trial performed very well, we have a higher confidence that U.S. trial will be successful as well,” Helio CEO Justin Chen Li told the Business Journal.
Li was honored last year at the Business Journal’s Innovator of the Year Awards for overseeing HelioLiver’s launch, growing Helio’s lab space and raising an oversubscribed $35 million Series B1. The company to date has raised more than $165 million, up from the $151 million it counted last September.
LAMH’s version of HelioLiver tailors to the “unique genetic makeup of the Asia-Pacific population,” which “sets it apart from conventional solutions,” company officials said.
“It has less to do with the genomic variation of ethnicity, and more to do with the etiology [or causes] of the disease,” Li said.
In China, hepatitis B is the primary driver for high risk of liver cancer. By contrast, causes for liver cancer in the U.S. are more diverse, some of which include alcoholic liver disease and fatty liver disease as well as hepatitis.
LAMH’s test aims to help some of China’s 87 million people living with hepatitis B. The country’s hepatitis B patients comprise about a third of the global population who are living with the disease.
Chronic hepatitis B infections cause at least 54% of all cases of liver cancer worldwide, according to Helio.
LAMH’s test offers early detection hepatocellular carcinoma—the most common form of liver cancer—using genomic and AI technology.
Detecting liver cancer in the early stages increases a patient’s five-year survival rate by 13 times, according to Helio.
The company expects to get the FDA’s greenlight for its HelioLiver test in 2024. It’s planning to submit its clinical trial to the FDA by the end of the year.
The Clinical Laboratory Fee Schedule, which prices medical products for health insurance issuers, Medicare and Medicaid, set the cost of HelioLiver at $662.32.
“That was a big win for us,” Li said. “Our test is favorably priced but still in the same range as competitors.”
