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Accelerate your clinical development in hereditary diseases

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.
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Proven expertise in CDx development
We have more than 20 years of expertise in collaborative CDx development with pharmaceutical companies. The FDA has granted us 11 Pre-Market Approvals (PMAs) for our CDx assays, each of them associated with a drug approval. These were all developed and clinically validated in close collaboration with a pharmaceutical partner to support a new therapeutic.
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
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One partnership, a global end-to-end solution for biopharma

One partnership, a global end-to-end solution for biopharma

Commercialize your CDx assay worldwide

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After your therapeutic and CDx are approved, QIAGEN and Helix will immediately commercialize your CDx assay worldwide. This innovative partnership can also aid your program with valuable adjacent capabilities, including custom genotype and phenotype-based sample identification for research, clinical trials and real-world evidence. Plus, expertise in genetics methods to deliver unparalleled insights.
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

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Helix population genomics programs can flexibly enroll all-comer populations, including patients with neurodegenerative, cardiovascular, autoimmune and inflammatory diseases. Individuals who enroll can be screened for specific genotypes and phenotypes of interest for research, trial enrollment, and RWE studies. By partnering with Helix, pharma companies can dramatically accelerate timelines to identify and recruit patients who meet specific clinical and genetic criteria for studies. Furthermore, Helix’s dedicated team of genetics experts provide pharma companies with insights that improve success in research, development, and commercialization of therapies.
Learn more about our partnership with Helix
Read press release

Trademarks: QIAGEN®, Sample to Insight®, QIAseq® (QIAGEN Group); Exome+® (Helix OpCo, LLC).

References

  1. 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.
  2. 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.