Helio Genomics · Newsroom
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Helio Genomics is an AI-powered precision cancer detection company. Our first commercial test, HelioLiver™ LDT, is a simple blood draw for the early detection of hepatocellular carcinoma — validated in a prospective, peer-reviewed pivotal trial and available to order nationwide through Quest Diagnostics.
Years of published science in cell-free DNA methylation, from foundational research to a pivotal clinical trial.
Peer-reviewed publications, including Nature Materials, PNAS, Science Translational Medicine and the Journal of Hepatology.
Evaluable participants in CLiMB, our prospective multicenter pivotal trial, across 42 U.S. clinical sites.
Quest Diagnostics patient service centers nationwide where HelioLiver can be collected, live since April 2026.
The Opportunity
Why liver cancer, and why now
Liver cancer is one of the few major cancers where incidence is still rising, where outcomes depend almost entirely on the stage at which it is found, and where most eligible patients are never surveilled at all.
Found early
Five-year relative survival when liver cancer is diagnosed while still localized.
American Cancer Society, Liver Cancer Survival Rates (SEER, 2014–2020 diagnoses)
Found late
Five-year relative survival once the disease has spread to distant sites.
American Cancer Society, Liver Cancer Survival Rates (SEER, 2014–2020 diagnoses)
New cases of liver and intrahepatic bile duct cancer expected in the United States this year, against 30,980 deaths. Incidence has tripled over the past four decades.
American Cancer Society, Cancer Facts & Figures 2026Of eligible patients with cirrhosis actually receive the recommended six-monthly surveillance. At community centers adherence falls to around 9%.
Wolf et al., Hepatology 2021 — 29 studies, 118,799 patientsProjected growth in global liver cancer cases by 2050, to 1.52 million a year — with at least 60% considered preventable.
Lancet Commission on liver cancer, 2025The Evidence
A pivotal trial, published and peer-reviewed
The CLiMB trial was published in the Journal of Hepatology in May 2026. It is a prospective, blinded, multicenter study in patients with cirrhosis, with multiphasic MRI as the reference standard for every participant.
Trial design
- Prospective and blinded — not a retrospective case–control analysis.
- 1,268 evaluable participants, including 46 with confirmed HCC, across 42 U.S. clinical sites.
- More than 80% enrolled at community-based centers rather than specialist academic hospitals, so the results reflect real-world screening.
- Multiphasic MRI as the reference standard in every participant, read centrally by board-certified radiologists using LI-RADS.
- Both co-primary endpoints met — superior sensitivity and non-inferior specificity against ultrasound.
Headline results
HelioLiver Ultrasound
- 47.8% vs 34.8% against ultrasound and AFP combined.
- 87.6% specificity, non-inferior to ultrasound (93.9%), with a 97.8% negative predictive value (97.2%).
- Ultrasound detected no lesions at 2 cm or smaller in the trial — four times more early-stage disease found by HelioLiver.
Taggart DJ, Mahajan S, Gallant MA, et al. A multi-analyte cfDNA blood test for early HCC detection. Journal of Hepatology. 2026. doi:10.1016/j.jhep.2026.04.012
ENCORE
The earlier prospective, blinded multicenter validation study of HelioLiver, published in Hepatology Communications in 2022.
Thirteen years of science
Nine peer-reviewed publications spanning cell-free DNA methylation, multimodal epigenetic sequencing and two cancer indications.
Read the full record
Every publication, with journal, year and abstract, is listed on our publications page.
View publications →Commercial Reach
Built to be ordered, delivered and scaled
Access, field presence and patient pathways are in place today — a commercial infrastructure most companies at this stage of evidence are still building.
Rural access
Microsoft
A member of Microsoft for Startups, Helio Genomics contributes to the Microsoft co-chaired Rural Health Transformation Collaborative, expanding access to earlier detection in underserved rural communities.
Underserved rural communities
Access
Quest Diagnostics
Providers with an existing Quest account can order HelioLiver through Quest’s infrastructure of approximately 7,700 patient service centers and more than 900 EHR systems nationwide. Live since April 2026.
~7,700 patient service centers
Field presence
Syneos Health
A national commercial field deployment to hepatologists and gastroenterologists, with targeted engagement and education delivered through Syneos’ AI-powered Kinetic platform.
Nationwide specialist coverage
Patient pathway
LiverRight
A strategic partnership with the National Virtual Clinic for Liver Disease, connecting patients to board-certified hepatologists in all 50 states within days rather than months.
50 states specialist accessCredentials
Laboratory, reimbursement and regulatory position
CLIA-certified laboratory
HelioLiver is performed in Helio’s own clinical laboratory, regulated under the Clinical Laboratory Improvement Amendments of 1988.
Established reimbursement
The American Medical Association issued HelioLiver a Category I CPT Proprietary Laboratory Analyses code, 0333U, in July 2022 — an established billing pathway rather than a code still to be applied for.
Regulatory status
HelioLiver LDT is a laboratory-developed test. It has not been cleared or approved by the U.S. Food and Drug Administration. As an LDT, it is regulated under CLIA.
In the News
Selected coverage
Helio’s science, commercial milestones and the Quest Diagnostics partnership have been covered across leading financial, industry and clinical media.
Helio Genomics Announces New HelioLiver Access Through Quest
Coverage of the expanded provider access for HelioLiver beginning April 2026: providers with existing Quest accounts can order the blood-based liver cancer test through Quest’s infrastructure of approximately 7,700 patient service centers and EHR integration. CEO Dr. Bharat Tewarie calls it “an important step in widening access to early cancer detection tools,” while Quest’s VP/GM of Oncology Asia Chang notes that “liquid biopsy may play a meaningful role in aiding earlier cancer detection.”
Read the coverage →
Media
Aug 13, 2026
Authority Magazine on Medium: Bharat Tewarie Of Helio Genomics On The 5 Things Everyone Needs To Know About Cancer
Read on →
Media
Aug 6, 2026
Unite.AI: Why Building Clinician and Patient Trust Is Healthcare’s Next Imperative
Read on →
Media
Jul 24, 2026
Life Science Daily: How Blood-Based Testing Could Close the Detection Gap
Read on →
Media
Jul 16, 2026
PR Newswire: Healthcare AI Leader Parminder Bhatia Joins Helio Board
Read on →
Media
Jun 16, 2026
DeciBio: Helio Genomics in May 2026 Liquid Biopsy Round-Up
Read on →
Media
May 19, 2026
PR Newswire: Helio & Syneos Health Partner to Scale HelioLiver Nationwide
Read on →
Media
May 6, 2026
Journal of Hepatology Publishes Landmark HelioLiver CLiMB Study
Read on →
Media
Mar 22, 2026
Simply Wall St: What Quest’s Cancer Screening Push Means for Investors
Read on →
Track Record
Milestones
- 2016
Helio Genomics founded, with an early cancer-detection methylation profile built on thousands of novel biomarkers.
- 2017
First publications on methylation for early cancer detection, in Nature Materials and PNAS.
- 2021
ENCORE completed — a prospective, blinded, multicenter study — and HelioLiver launched as a laboratory-developed test. CHALM prediction method published in Nature Communications.
- 2022
ENCORE published in Hepatology Communications, and the AMA issues HelioLiver a Category I CPT PLA code (0333U).
- 2024
CLiMB data presented at the EASL Congress and at AASLD.
- 2025
Dr. Bharat Tewarie appointed CEO, and a strategic partnership with LiverRight connects patients to hepatology specialists in all 50 states.
- Mar 2026
Quest Diagnostics agreement brings HelioLiver to approximately 7,700 patient service centers and more than 900 EHR systems nationwide.
- May 2026
CLiMB published in the Journal of Hepatology, and a commercial partnership with Syneos Health is announced.
- Jul 2026
Parminder Bhatia joins the Board of Directors, bringing healthcare artificial-intelligence leadership.
Leadership
The people behind the company
Helio is led by an executive team from global biopharma and diagnostics, governed by a board with healthcare and artificial-intelligence leadership, and advised by hepatologists from the institutions that define the field.
Leadership team
- Bharat Tewarie, MD, MBAChief Executive Officer
- Alex Brenner, MBAChief Financial Officer
- Jon BerarducciVice President, Commercial Operations
- Sharon LiangVice President, Regulatory Affairs and Quality
- Shivani Mahajan, PhDHead of Computational Science
- Richard Van Etten, MD, PhDChief Medical Advisor
- Wei Li, PhDChief Bioinformatics Advisor
Board of directors
- Shu Li, PhDExecutive Chairman
- Bharat Tewarie, MD, MBAChief Executive Officer
- Terry Belmont, MPHBoard Member
- Aarif Nakhooda, MBABoard Member · Audit Committee Chair
- Parminder BhatiaBoard Member · healthcare artificial-intelligence leadership
- Richard Van Etten, MD, PhDChief Medical Advisor
Medical & scientific advisers
- Mindie Nguyen, MD, MAS, AGAF, FAASLDHepatology Advisor · Lead Principal Investigator, CLiMB
- Morris Sherman, MD, PhDPresident, International Liver Cancer Association
- Ghassan K. Abou-Alfa, MD, MBAMemorial Sloan Kettering Cancer Center
- Yujin Hoshida, MD, PhDLiver Tumor Translational Research Program, UT Southwestern
- Robert Gish, MDThe Hepatitis B Foundation
- Robert Langer, ScDScientific Adviser