Helio Genomics announced a partnership with Ohio-based LiverRight Inc. to integrate its new early liver cancer detection test, LiverTrace, into LiverRight’s network of hepatology specialists.
Through the partnership, patients can immediately connect with a LiverRight provider to interpret their results and plan further treatment when needed.
LiverRight is the nation’s first and only virtual clinic focused on liver disease and serves patients in all 50 states.
“The LiverRight partnership is important because they are the largest virtual telemedicine group when it comes to hepatologists,” Chief Executive Dr. Bharat Tewarie told the Business Journal.
Helio is in pre-launch mode and gearing up to commercialize its main product, HelioLiver.
The multi-analyte blood-based test, which uses AI to detect and predict liver cancer in those who are at high risk, such as people with liver cirrhosis and chronic hepatitis B, is currently available as a laboratory-developed test (LDT) and awaits FDA approval.
Tewarie said that the company is “actively engaged with the FDA” on addressing comments and requests for additional data.
Detecting a “Silent Killer”
LiverTrace launched last month in a partnership with the American Liver Foundation to increase liver cancer awareness.
Liver cancer is known as a “silent killer” because patients don’t show symptoms in the early stages.
Survival rates increase by up to 10 times if caught early, but less than 30% are diagnosed early enough, according to LiverTrace’s website.
“The reason we wanted this new test to hit the market is to address this unmet need for accessible, non-invasive liver cancer surveillance,” Tewarie said.
“We felt that offering a test on a direct-to-consumer basis would give patients greater flexibility and access while we maintain the rigorous validation standards that we have in a CLIA-certified accredited laboratory.”
The test kit, which is also an LDT, includes a home visit from a certified phlebotomist that will use the materials in the kit to collect a blood sample, which is then sent to a lab for analysis with results expected to return within 14 days.
LiverTrace uses AI and machine learning to detect cancer biomarkers before a tumor is visible through ultrasound, according to Helio.
It costs $399 to purchase online and is not covered by insurance.
Preparing for Commercial Launch
Tewarie became the new CEO of Helio in April, succeeding Justin Chen Li, who remains the company’s president.
Li was a founding member of Helio and served as CEO for four years after previously serving as the company’s vice president of finance and business development.
Tewarie was brought on to lead the company’s next stage of growth after it launched HelioLiver for lab use in January.
“I was a great startup CEO for the company, but every startup will eventually outgrow its startup CEO and founding team,” Li previously told the Business Journal.
Tewarie, who brings 20 years of experience across biopharmaceuticals, medical devices and diagnostics companies, said that he wants to use commercial strategies including AI-driven marketing and e-commerce platforms.
