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From One Million Genomes to Routine Care: Helix CEO James Lu on Precure

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Helix + Precure

1. Mayo Clinic has selected Helix as the multi-omic lab provider and AI tools partner for Precure. What made Helix the right fit for an initiative of this scale, and what will Helix be responsible for?

“Helix brings together the lab, data infrastructure and experience of putting genomics into care. For Precure, we will generate clinical whole-genome sequencing and research-grade multi-omics data from approximately one million biospecimens and provide AI tools for research and clinical workflows. The broader opportunity is to make the genome an enduring patient resource, useful again as science advances and a patient’s needs change.”

– James Lu, M.D., Ph.D., CEO and co-founder of Helix

2. Precure aims to sequence around one million biospecimens. What are the biggest operational challenges in running genomic testing and next-generation sequencing at this scale, and how is Helix preparing for them?

“Helix already operates one of the largest CLIA/CAP NGS operations in the country – and we are deeply familiar with the need to maintain quality and consistency, from sample handling through sequencing and analysis. We’re combining our existing capabilities with a new sequencing platform: Ultima’s UG200 systems, to enable our systems to cost effectively scale.”

– James Lu, M.D., Ph.D., CEO and co-founder of Helix

3. How will the data infrastructure supporting Precure ensure that genomic data is secure, well governed and usable for both clinical care and research?

“Protecting patient privacy and safeguarding health information are foundational to Mayo Clinic’s mission. Mayo Clinic is committed to maintaining the privacy, confidentiality and security of patient information and follows established privacy, security, compliance and governance requirements to protect data.”

– Mayo Clinic

Whole genome sequencing as standard of care

4. Precure is designed to help make whole genome sequencing the standard of care. What still stands between today’s practice and that goal, whether in cost, clinical workflows, reimbursement or physician adoption?

“Helix has been operating at the forefront of these questions over the past few years with its network of health system partners. Data generation is a necessary but not sufficient component of helping genomics become part of the standard of care. Helix is focused on making the information usable in everyday care: integrating it into workflows, helping physicians act on results and building evidence for reimbursement.”

– James Lu, M.D., Ph.D., CEO and co-founder of Helix

5. How can generating genomic and proteomic data at population scale enable earlier diagnosis and intervention? Could you share an example of a disease area where you expect this to make a measurable difference?

“Our population genomics findings presented at ASHG show why this matters. Identifying inherited cancer risk was followed by increased screening among younger BRCA1/2 and Lynch syndrome carriers. That is a concrete change in care, not simply another result in a database. Adding proteomic and longitudinal clinical data could help us understand how disease develops and identify additional opportunities to intervene earlier. We’re seeing, across all major therapeutic areas, that broader access results in better clinical outcomes.”

– James Lu, M.D., Ph.D., CEO and co-founder of Helix

6. How do you see multi-omic data changing the way clinicians deliver personalised care in routine practice, beyond specialist settings?

“The goal is not to turn every primary care physician into a genomics or proteomics expert. It is to make relevant information available when a decision arises, such as whether someone needs earlier screening or a specialist referral. Over time, validated proteomic insights could add information about how disease is developing. Each application needs evidence and a clear next step, not just more data for clinicians to interpret.”

– James Lu, M.D., Ph.D., CEO and co-founder of Helix

Data, research and AI

7. The Helix Research Network holds over 50 trillion genomic data points and more than 560,000 sequenced exomes. How is this network being used today, and how does GenoSphere support researchers working with this data?

“The Helix Research Network is the world’s largest precision health network, helping health systems and life sciences organizations transform genomic data into actionable clinical insights. The network connects genomic information with years of clinical records, so researchers can study how genetic differences relate to disease and patients’ experiences over time. One example is our work with partner health systems on genetically estimated lipoprotein(a) and cardiovascular risk. Helix Explorer, our TRE, and our AI research agent Nettie, give researchers a secure, governed environment to work with these linked data, supporting questions about disease biology, biomarkers and clinical trials.”

– James Lu, M.D., Ph.D., CEO and co-founder of Helix

8. What role will AI tools play in turning population-scale genomic data into clinically actionable insights, and where do you see their current limitations?

“AI agents can help researchers move from a question to an analysis, and help providers support genetic-testing workflows. Our benchmarks indicate that researchers who use our research agents can execute standard genetic studies up to 4x faster, and that clinical practices that leverage our clinical agents can offload up to 50% of clinical workloads. Nonetheless, evaluations are incredibly important as AI does not remove responsibility for scientific or clinical judgment.”

– James Lu, M.D., Ph.D., CEO and co-founder of Helix

Impact on pharma and the healthcare value chain

9. What does population-scale genomic data mean for pharmaceutical companies, particularly in target discovery, patient stratification and clinical trial design?

“For pharma, the value is connecting genetic variation to what actually happens to patients: how disease develops, how people are treated and what outcomes follow. That can strengthen target selection, identify useful biomarkers and help define populations for clinical trials. The objective is better decisions across the drug development life cycle, not simply larger datasets. GenoSphere is designed to make those connections easier to investigate.”

– James Lu, M.D., Ph.D., CEO and co-founder of Helix

10. How should health systems, pharma and diagnostics companies work together to make sure the benefits of genomic medicine reach patients broadly and equitably?

“Start with the health systems and communities where people already receive care. Health systems bring the clinical relationships; diagnostics and technology partners help make testing and follow-through practical; pharma can help translate discoveries into treatments. Access needs to mean more than offering a test. Patients also need understandable results and a path to appropriate care, including those outside specialist centers.”

– James Lu, M.D., Ph.D., CEO and co-founder of Helix

Looking ahead

11. Where do you expect precision medicine and genomics to be in five years, and what will Helix’s role be in that future?

“Five years from now, I think genomics will increasingly become a foundational layer of healthcare rather than a test we order for a specific patient at a specific moment. More patients will have genomic information available as part of their health record, and we will be able to combine that information with clinical, proteomic and other molecular data to build a much more complete picture of health and disease. Helix’s role is to build the infrastructure that connects those pieces at scale. Ultimately, genomics should become part of the underlying infrastructure of healthcare, available when it can help prevent disease, inform a diagnosis, guide treatment or enable the next discovery.”

– James Lu, M.D., Ph.D., CEO and co-founder of Helix

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