Golden Helix
Enabling Genomic Medicine with Bioinformatics Excellence

The speed, accuracy, high-throughput, and cost-effectiveness of next-generation sequencing (NGS) are helping to accelerate advancements in precision medicine. With an array of factors contributing to its popularity, NGS has become a fundamental tool for researchers in diverse disciplines, from life sciences, translational, and consumer genomics to clinical and molecular diagnostics. Managing the data for analysis of genetic variants presents a challenge. The complex processes often prevent organizations from deriving actionable insights to ensure improved patient outcomes. This undertaking requires unparalleled domain expertise and analysis excellence—a combination that makes Golden Helix a pioneer in the precision medicine space.

“We’re enablers of precision medicine, committed to revolutionizing the way genomic medicine has been used. Our goal is to reshape the healthcare and genetic analysis space by bringing our expertise to the table,” says Dr. Andreas Scherer, president, and CEO.

Staying true to this objective, the Golden Helix offers a cutting-edge software suite that allows researchers and clinicians to analyze and interpret genomic data with accuracy and efficiency. Drawing insights from its 25-plus years of experience, Golden Helix delivers a complete portfolio of NGS analysis solutions that can take raw, sequenced data from multiple sources, curate clinical evidence, and create clinical reports. Its solutions help identify genetic mutations and variants in samples and pinpoint the potentially damaging ones with pathogenicity. Clinicians, researchers, and healthcare providers can analyze samples according to applicable standards, such as ACMG (American College of Medical Genetics), American College of Medical Genetics, and AMP (Association for Molecular Pathology), and unlock the full potential of genetic insights to diagnose and treat diseases.

Golden Helix delivers its software packages in different tiers and configurations to hospitals and clinical labs, equipping them with the infrastructure and capabilities to conduct analysis. From accelerating genetic analysis to improving patient outcomes, the advanced, user-friendly, and affordable software platforms assist the healthcare community in their quest to formulate effective and personalized healthcare interventions.

“Our software packages are easy to use and affordable, allowing hospitals and labs to adopt and make them a part of standard care,” says Dr. Scherer.

The team also provides training and support to help hospitals, clinical labs, research facilities, and government organizations make sense of their sequenced data. Golden Helix’s competitive edge lies in its commitment to maintaining the highest standards of excellence, flexibility, and scalability in its products and services. It stays on top of innovations in genomic technology, ensuring clients have access to the most advanced tools and resources. One example is a robust pharmacogenomics solution that will empower it to add pharmacogenetics analytics capabilities as an integrated component of NGS-based genetic testing.

As a client-centric solution provider, Golden Helix proactively gathers customer feedback, which serves as the cornerstone for its product development and innovation efforts. The research and development of Golden Helix products has been partially funded by the NIH for the last 10 years.

As of April 2024, Golden Helix’s genetic analysis platform VarSeq Suite received CE mark approval. This significant regulatory milestone paves the way for the expansion of Golden Helix's advanced genetic analytics products to the European market, ensuring compliance with the European Union's health, safety, and environmental protection standards. The CE mark certifies that Golden Helix's genetic analysis platform meets the European In Vitro Diagnostic Regulation (IVDR 2017/746) requirements, which govern the sale of in vitro diagnostic devices within the European Economic Area (EEA).

"Obtaining the CE mark is a pivotal step for Golden Helix as we expand internationally," says Dr. Scherer. "This approval not only demonstrates our commitment to compliance and quality. It enhances our ability to serve healthcare providers with advanced genetic testing solutions that improve patient outcomes."

This news follows an announcement earlier this year that Golden Helix received its ISO 13485:2016 certification for its Medical Device and Quality Management System. This certification demonstrates Golden Helix’s continuous efforts for safety and customer satisfaction, quality improvements, and risk management. Golden Helix is a perfect partner for clients, supporting a broad spectrum of NGS analytics for clinic and research use cases, including cancer and germline disease analysis. As the world continues to unlock advancements in the human genome, it will remain at the forefront, driving progress, and transforming the way we approach healthcare.