Helio Genomics is now in full launch mode for its live cancer detection test through a new distribution partnership with Quest Diagnostics, one of the largest diagnostic testing providers in the U.S.
Finding a partner like Quest to help bring its product to market faster is what Dr. Bharat Tewarie set out to do when he was appointed chief executive last August.
“It’s very important for a company like Helio to build partnerships with established entities who help us scale,” Tewarie told the Business Journal.
The company’s HelioLiver test, which became available to Quest’s 7,700 patient service centers and in-office phlebotomists this month, is now commercially available nationwide.
Helio is currently selling the test as a laboratory-developed test and is awaiting FDA approval.
It submitted its premarket approval application in 2024 and previously expected approval in the second quarter of 2025.
“We’re just following the plans that we have to do this in the right time with the right submission strategy, and that is working well,” Tewarie said.
Partnership Business Strategy
Under the partnership, Quest providers will be able to directly access HelioLiver through their existing Quest account and electronic health record.
The Quest partnership follows another partnership announced in January with Ohio-based LiverRight Inc., the nation’s first and only virtual clinic focused on liver disease, to integrate its early liver cancer detection test, LiverTrace, into its network of hepatology specialists.
Helio launched LiverTrace in partnership with the American Liver Foundation to raise awareness of liver cancer. The test uses AI and machine learning to detect cancer biomarkers before a tumor is visible through ultrasound.
Tewarie hinted at additional partnership announcements in the coming months, emphasizing the importance of partnerships as a key part of Helio’s business strategy.
“Partnerships help us scale in the most efficient manner,” he said.
Expanding Pipeline of Liver Cancer Tests
Tewarie said the company is exploring what a new test could be.
“We’re looking into building a portfolio of other tests related to liver cancer,” he said.
The first piece is its existing HelioLiver test, which aims to catch liver cancer at its early stages with a simple blood draw.
The company is developing two new tests in liver cancer—one to track a patient’s response to liver cancer treatment and a second to monitor for disease recurrence.
“After somebody receives a liver transplant, the liver cancer can come back, so you have to monitor for that too,” Tewarie said.
“Helio Genomics is in the business of early cancer diagnostics, and we will bring many more products to the people who need their cancer diagnosed as early as possible.”
