A recent research study by Helio Genomics, one of Orange County’s better-funded upstart diagnostics firms, suggests it’s found a way to better detect early-stage cancer with a simple blood test.
The Irvine-based cancer diagnostics firm collaborated with the University of California, Irvine for the study, which tested using multiple biomarkers to detect early signs of colon cancer more accurately. The study was published in Genome Medicine.
“Cancer is multidimensional, so you should take a multidimensional approach to detect it,” Chief Executive Justin Chen Li told the Business Journal.
Li says the results from the study will help advance the second generation of the company’s first product, HelioLiver, a test that it says detects early-stage liver cancer better than traditional methods.
The company is still going through the approval process for HelioLiver and will be submitting it to the Food and Drug Administration (FDA) this summer, according to Li.
Helio partnered with Grace B. Bell Endowed Chair and UCI professor of bioinformatics Wei Li, who has also served as the company’s chief bioinformatics adviser for the last four years.
The focus of the study is multimodal epigenetic sequencing analysis (MESA), a new cancer detection approach developed and patented by Helio.
Justin Li describes MESA as “looking at the problem from multiple angles.”
It combines two methods known as DNA methylation, which Helio has specialized in since 2017, and fragmentomics.
Cancer sheds small pieces of DNA into the bloodstream. Fragmentomics helps predict if any DNA fragments found in the bloodsteam are indicative of cancer.
“When you train the algorithm with just methylation, it doesn’t perform as well as if you add these other features from MESA,” Li said.
While the study specifically focused on colon cancer, MESA can be applied to other cancers as well.
The results found MESA to be more effective than typical diagnostic tests such as ultrasounds, which are used to diagnose liver cancer.
Adherence rates for medical guidelines pertaining to liver and colon cancer are notoriously low, Li said.
People with liver cirrhosis are recommended to get an ultrasound screening for liver cancer about every six months, yet only 9% of them do, according to Li.
A blood test, however, would make it easier for people to adhere to guidelines, he said.
“While people are getting cholesterol tests or other annual regular blood tests, you can easily take another couple tubes for the HelioLiver test,” Li said.
Helio has raised more than $180 million to date. This total includes Asia operations from Helio’s sister company Laboratory for Advanced Medicine & Health Group (LAMH).
El Monte-based Fulgent Genetics Inc. (Nasdaq: FLGT) is a commercial partner that helped lead a prior $35 million Series B1 funding round.
Li said that the latest results have been “very positively accepted” by hepatologists and key industry leaders that they’ve shared the data with.
In the meantime, Li said the company will be busy expanding its team, as well as its lab in Indiana, to prepare for the commercialization of HelioLiver.
“We want to make sure that we’re ready to scale ahead of FDA approval,” Li said.
The company counts about 150 employees across the globe, with 50 in the U.S.