woman, possibly a doctor looking at the screen

Precision diagnostics for non-oncology indications

Redefining the future of non-oncology diseases

Precision medicine is reshaping the landscape of disease treatment. Instead of a one-size-fits-all method, it identifies the right treatment for the right patient at the right time.

While companion diagnostics (CDx) are widely used in oncology, they are evolving to meet the diverse needs of physicians and patients in other health settings, such as non-oncology diseases.

Importantly, they also provide new hope in the fight against diseases such as:

icon-check-mark-circleAlzheimer's disease
icon-check-mark-circleInflammatory diseases
icon-check-mark-circleCardiovascular diseases
icon-check-mark-circleNeurodegenerative diseases
icon-check-mark-circleMetabolic diseases

Examples of the diseases and genes for which we can develop a CDx

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
MASH (nonalcoholic steatohepatitis)	PNPLA3
Parkinson’s disease	SNCA LRRK2 GBA1 GRN
Type 2 diabetes mellitus	GLP1R

Obtain deeper insights from multiplex testing

For detecting complex syndromes and genotypes in diseases with high patient incidences, such as Alzheimer's disease or inflammatory diseases, the QIAstat-Dx instrument delivers a true Sample to Insight solution for reliable, faster and cost-effective testing. We have already placed >4000 instruments at laboratories worldwide.

The IVD QIAstat-Dx instrument redefines ease of use, as the entire procedure is automated through one cartridge per sample with all dry and wet reagents onboard. Eight available reaction chambers per cartridge allow for up to 48-plex qPCR panel testing. Results are obtained in about an hour, with hands-on time of around one minute: All-in, no other instruments required.

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

Screen patients across the Helix network with genetic and clinical criteria to quickly recruit the right patients for trials

Select the right trial subjects for the right treatment

We've partnered with Helix to support your clinical development with investigational use only (IUO) and performance evaluation only assays (PEO). The innovative exome assay is based on the FDA-authorized Helix Laboratory Platform technology.* This enables you to select trial subjects from a fast-growing database of >500,000 genetically profiled individuals.

As of February 2025, Helix has partnerships with 16 health systems across the USA. The high-quality genomic data generated by these partnerships are redefining precision medicine drug discovery.

* The clinical trial assay developed by Helix is based on the Helix Laboratory Platform and used in the US. Outside the US, we will use our whole exome assay to set up labs in territories where you require local clinical trial testing.

Webinar

GIST treatment decisions you can have confidence in

How are CDx transforming personalized healthcare beyond oncology?

Companion diagnostics (CDx) have enormous potential to advance treatment of non-oncology diseases. Discover how Neuron23 is using CDx to help identify Parkinson's patients who are likely to benefit from precision medicines.

Access webinar

Extensive experience in worldwide assay registration and commercialization

Choosing a CDx partner with a proven track record in IVD development is crucial for successful CDx–drug co-approval. We are uniquely positioned leaders in molecular CDx development with over 20 years of experience. With our longstanding commercialization expertise, we can help you achieve global registration success and optimal test access at drug approval – in any market.

Our IVD assays have been approved by regulatory bodies around the world based on our competencies with global regulatory requirements, including the US FDA and European IVDR. Partner with our experts to navigate global clinical trial site setup and local testing requirements on your path to commercialization.