
The global partnership of QIAGEN and Helix can help you keep and accelerate clinical trial timelines in hereditary diseases through an NGS companion diagnostics (CDx) strategy. Leverage an immediately available Helix Exome+Ⓡ assay that is run on the first and only exome platform cleared by the FDA.
Our teams bring world-class experience developing and commercializing CDx through all phases of your clinical trial through commercialization.Benefit from the first-ever FDA-authorized whole exome sequencing portfolio
- The Helix Laboratory Platform (HLP) is the first – and remains the only – FDA-authorized whole exome sequencing platform. This platform runs Helix’s proprietary Exome+® assay in its CAP/CLIA laboratory based in San Diego, CA.
- The Exome+® is immediately available to support all phases of pharmaceutical research and clinical trials, from research and development through commercialization to support your CDx strategy for hereditary disease.
- Helix uses the same assay in its population genomics programs and has created a world-leading population genomics database which can assist in research and development as well as identify potential patients for clinical trial enrollment.
Learn more about the design and performance of the Helix Exome+® assay in our white paper.
The assays have been approved by regulatory authorities around the world based on our competencies with global regulatory requirements, including IVDR. Our pharma partners have the IVD assay available wherever the test is needed to identify the right patient for the right treatment. Outside the US, you can build on our competencies in global clinical trial site setup and support and on local testing using the QIAseq® Human Exome assay in territories where it is required.
Discover how we can support you on your clinical development journey.
Discover how you can rapidly identify the right patients for your clinical trial
One partnership, a global end-to-end solution for biopharma
Commercialize your CDx assay worldwide
Helix’s experienced market access teams work with payers to establish reimbursement, and its CAP/CLIA laboratory in San Diego, CA can perform clinical testing at drug launch for any patient in the US.
Globally, QIAGEN's commercialization work is closely coordinated with regulatory submission of drug and test, so the assay is available on the same day as the drug launch anywhere in the world. We have a network of leading laboratories in all pharmaceutical target markets to implement new CDx using a kit-based QIAGEN IVD assay. The network of labs is continuously expanding to cover additional countries in which your test needs to be available for routine patient testing.
Capabilities that extend beyond CDx
Learn more about our partnership with Helix
Trademarks: QIAGEN®, Sample to Insight®, QIAseq® (QIAGEN Group); Exome+® (Helix OpCo, LLC).
References
- Eberle, M. A. et al. A reference data set of 5.4 million phased human variants validated by genetic inheritance from sequencing a three-generation 17-member pedigree. Genome Res. 2017;27:157–164.
- Zook, J. M. et al. Integrating human sequence data sets provides a resource of benchmark SNP and indel genotype calls. Nat. Biotechnol. 2014;32: 246–251.