woman, possibly a doctor looking at the screen

De-risk and accelerate your clinical trial in non-oncology diseases

Select the right trial subjects for the right treatment

We’ve partnered with Helix to help you profile potential subjects with an exome assay based on the FDA-authorized Helix Laboratory Platform technology.

Now, you can select your trial subjects from a database of 500.000 genetically profiled individuals.

Examples of non-oncology diseases and genes covered by the Helix exome assay

Hereditary disease	Gene
Atherosclerotic cardiovascular disease	PCSK9
Autoimmune diseases	CD40L
Alzheimer’s disease	PSEN1 PSEN2
Cardiovascular disease	TNNT2 TTR
Chronic kidney disease	APOL1
Familial hypercholesterolemia	PCSK9 APOB ANGPTL3
Frontotemporal dementia	GRN
Inflammatory diseases	GLPR2 IRAK4
NASH (nonalcoholic steatohepatitis)	PNPLA3
Parkinson’s disease	SNCA LRRK2 GBA1 GRN
Type 2 diabetes mellitus	GLP1R

The clinical trial assay developed by Helix – based on the Helix Laboratory Platform – allows you to customize the biomarkers of your clinical trial down to a single SNP or expand them to cover a multi-gene polygenic risk score. Furthermore, genetics experts at Helix can identify additional biomarkers that improve your inclusion and exclusion criteria.

Accelerate your clinical development

We are using a clinical trial exome assay developed by Helix. This technology was used to sequence the DNA of more than 500,000 individuals, with the data stored in a database linked to Electronic Health Records.

Helix and its health system partners continuously enroll more than 100,000 patients a year across a diverse mix of patient populations and continue to sequence their DNA using the Helix assay. This simplifies identification of potential participants for your clinical trial.

All individuals with sequencing data in the population genomics database have given permission for their health record and genomic data to be shared. Their consent does not just cover research purposes, it also allows Helix’s trusted health system partners to contact them about potential participation in clinical trials.

A phase II clinical trial of the phosphatidylserine targeting antibody, bavituximab in combination with pembrolizumab in patients with advanced hepatocellular carcinoma

Webinar

Vital role of CDx in hereditary diseases

Vital role of CDx in non-oncology diseases

Gain new insights into the role of CDx in the development of targeted therapeutics

Access webinar

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

Build on our expertise in global IVD development

Together with our partner Helix, we provide biopharma companies like yours with a global solution for companion diagnostics. Our range of experience and years of experience means we can navigate the regulatory paths, satisfy requirements and drive your success.

Our teams have world-class experience in collaborative development of CDx with pharmaceutical companies throughout all phases of clinical trials. The FDA has granted us 14 Pre-Market Approvals (PMAs) for our CDx assays, each of them associated with a drug approval. These were all developed and clinically validated to support a new therapy.

QIAGEN assays have been approved by regulatory authorities around the world based on our competencies with global requirements, including IVDR.
The clinical trial assay developed by Helix is based on the Helix Laboratory Platform and used in the US. Outside the US, we can use our whole exome assay to set up labs in territories where you require local clinical trial testing.