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DNA Methylation Analysis for Early Detection of Various Cancers

Interview May 29, 2019 5 min read Technology Networks
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A Technology Networks Q&A with LAM’s (now Helio Genomics) Richard Brand and Dhruvajyoti Roy on cfDNA methylation, the IvyGene tests, and new nasopharyngeal carcinoma data.

A Q&A with Richard Brand (CFO) and Dhruvajyoti Roy (Director of Technology) of the Laboratory for Advanced Medicine (LAM) — the company that would become Helio Genomics — conducted by Laura Elizabeth Lansdowne for Technology Networks.

When a cancer cell dies, its DNA is released into the blood as cell-free DNA (cfDNA), which retains a DNA methylation pattern corresponding to the cell it originated from. Because a normal cell’s transformation into a cancer cell is accompanied by significant gene-expression and methylation changes, it is possible to differentiate normal from cancer cells by detecting which DNA sites are methylated.

Q: Could you tell us more about the Laboratory for Advanced Medicine (LAM)?

A: LAM is a commercial-stage medical technology company focused on developing and commercializing new technologies specifically for the early detection and intervention of cancer, with streamlined product development to rapidly produce highly accurate, life-saving technologies.

Q: Your platform is based on cell-free DNA (cfDNA) methylation detection. Could you touch on the underlying science?

A: Alterations in DNA methylation play a key role in tumor initiation, and methylation markers are well established for detecting various cancer types at early stages. Cancer-specific DNA methylation patterns of cfDNA isolated from blood are a non-invasive way to obtain representative epigenetic information from solid tumors. Methylation is the next big shift in cancer detection because large-scale epigenetic alterations potentially have greater ability than somatic mutations to detect and classify cancers early.

Q: What is “IvyGene”?

A: IvyGene is the product name for our services and is the core foundation of our early cancer confirmation tests. We have two commercially available products, IvyGene CORE and IvyGene Liver, that confirm the presence of multiple cancers as early as stage I. IvyGene CORE has a sensitivity of 84% and specificity of 90%, and the IvyGene Liver Test has a sensitivity of 80% and specificity of 86%.

Q: You recently presented new data on nasopharyngeal carcinoma (NPC) at ASCO. What were the key findings?

A: The study showed an overall sensitivity of 97% and combined specificity of 100%. It used samples from 168 subjects, including 59 diagnosed with NPC (Stage I-IV), 14 with benign nasopharyngeal disease, and 43 healthy subjects. Of the 59 NPC subjects, 57 were correctly identified (97% sensitivity, with 92-100% across stages). All 43 healthy donors and all 14 benign-disease subjects were correctly identified as negative for NPC.

Q: What are the implications and next steps?

A: Because most NPC patients present with advanced disease, a non-invasive assay for early detection could greatly increase the chances of effective treatment and improve outcomes at lower cost. We plan additional validation in a large NPC cohort with the objective of making an accurate test commercially available to the at-risk population.

Read the Full Article

Source: Technology Networks. Richard Brand and Dhruvajyoti Roy spoke with Laura Elizabeth Lansdowne. Read the full article.

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