Helix announced a global strategic partnership with QIAGEN N.V. to jointly develop companion diagnostics for hereditary diseases. As part of the collaboration, Helix will leverage the Helix® Laboratory Platform to develop companion diagnostics in the U.S., and QIAGEN will use the QIASeq Human Exome Kits in the rest of world. The Helix® Laboratory Platform is a whole exome sequencing platform run in Helix's San Diego based CLIA /CAP next-generation sequencing lab and will be the basis for companion diagnostic development and earlier stage assay development in the United States.

Helix is the first - and remains the only - company to receive De Novo Class II authorization of this platform from the U.S. Food & Drug Administration (FDA). Helix will develop companion diagnostics and clinical trial assays for all phases of clinical trials, as well as commercialize single site premarket approval (PMA) companion diagnostics. A pioneer in precision medicine, QIAGEN has more than 30 master collaboration agreements with global pharmaceutical and biotechnology companies to develop and commercialize companion diagnostic tests for their drug candidates.

QIAGEN's companion diagnostic offerings encompass technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) and digital PCR (dPCR), sample types from liquid biopsy to tissue, and disease areas from cancer to Parkinson's – including 11 FDA-approved PCR based companion diagnostics and a collaboration with Neuron23 announced in September 2022 to develop an NGS-based companion diagnostic for a novel Parkinson's disease drug. Leveraging an end-to-end platform, Helix enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Helix has partnered with leading health systems to enable population genomics programs of at least 100,000 patients each across the U.S. These programs dramatically accelerate patient identification and recruitment for clinical trials in hereditary diseases such as Parkinson's, cardiovascular or inflammatory disease like nonalcoholic steatohepatitis (NASH), power real world data or real-world evidence (RWD/RWE) services to generate high value insights, and bring deep genetic expertise and methodologies to examine sub cohorts both in early drug discovery and within a clinical trial.

The two companies will be providing more detail about their collaboration at the 41st Annual JPMorgan Health Care Conference in San Francisco this month.