What You Should Know:
– Helix, a leader in precision health announced the release of a new suite of pharmacogenomics (PGx) tests designed to enhance personalized care, particularly in oncology and neurology.
– Key among these are a test to identify patients with DPYD gene variants who may be at increased risk for severe side effects from certain chemotherapies, and a first-of-its-kind test that assesses APOE status relevant to newly available Alzheimer’s drugs.
Tailoring Treatment in Oncology and Neurology with Precision Insights
Helix’s expanded PGx offerings aim to provide clinicians with critical genetic information to guide treatment decisions. The new PGx Fluoropyrimidines DPYD Test provides insights on how patients metabolize cornerstone cancer therapies, such as those used for colorectal, breast, pancreatic, esophageal, and head and neck cancers. This helps identify individuals at risk for severe toxicity due to DPYD gene variants, a concern recently highlighted by the National Comprehensive Cancer Network.
Additionally, Helix has launched a novel PGx APOE test. This first-of-its-kind assay assesses a patient’s risk of serious side effects, including amyloid-related imaging abnormalities (ARIA), when treated with new Alzheimer’s drugs like Leqembi or Kisunla. Both medications carry FDA boxed warnings regarding risks for individuals with two copies of the APOE ε4 allele. With these additions, Helix now offers tests that provide information for all neurology and oncology-associated PGx haplotypes mentioned in FDA boxed warnings.
Advanced Technology for Accurate and Rapid Genetic Insights
Helix’s PGx tests are designed for leading accuracy across diverse populations, utilizing their proprietary Exome+® assay and a comprehensive star allele caller. A key feature is Helix’s “Sequence Once, Query Often®” model, which allows a patient’s exome to be sequenced just once, enabling future genetic tests to be ordered without the need for another sample in most cases. This efficiency means Helix’s PGx tests can typically return results within minutes, facilitating access to crucial genetic insights at the point of care for the first time.
Improving Patient Safety and Treatment Efficacy
The new tests are being welcomed by healthcare leaders for their potential to enhance patient safety and treatment personalization. “This is really about quality and safety, and is something we should be doing for every patient on these medications,” said Patrick J. Cawley, M.D., executive vice president for Health Affairs at the Medical University of South Carolina (MUSC), and CEO of MUSC Health. “With these tests coming available, the forefront of change has shifted from being years away, to today”. In March 2024, MUSC and Helix initiated a partnership aimed at improving healthcare outcomes by integrating genetic insights into clinical care and research.
Will Lee, Ph.D., chief science officer at Helix, emphasized the impact of such testing: “A recent preprint by the Helix Research Network showed that close to 30% of patients on a common antiplatelet medication were prescribed inappropriate drug regimens, resulting in a ~40% elevation of major adverse events, the majority of which occurred within two months. By focusing on patients with neurodegenerative conditions and cancer, and actively identifying those at higher risk for adverse outcomes, we can help providers treat vulnerable patients more precisely and effectively”.
A Comprehensive Suite for Diverse Therapeutic Areas
The newly launched PGx tests cover medications used to treat cancer, common cardiovascular diseases, gastrointestinal conditions, and pain, as well as guiding anesthesia administration. These new offerings complement Helix’s existing PGx tests for mental health medications, blood clotting, and immune suppression, further broadening the company’s support for clinicians aiming to optimize treatments and minimize side effects.
Powering Precision Health Through Research and Collaboration
Helix, alongside its partners, has developed the Helix Research NetworkTM, described as the largest and fastest-growing precision clinical research network globally. This network generates real-world evidence to support a broad range of initiatives, including studies demonstrating the clinical utility of genomics by linking genetic data with longitudinal clinical records for consented participants.
