Partnering for precision diagnostics

Transforming healthcare: The power of precision medicine

Precision medicine is reshaping the landscape of disease treatment, offering personalized therapies that target the unique genetic makeup of each patient.

Instead of a one-size-fits-all method, precision medicine uses detailed data like DNA sequencing and biomarkers to select the most effective treatments for specific patients, offering new hope in the fight against diseases like cancer and Parkinson’s.

From targeted drugs to advanced genomic testing, these breakthroughs are rewriting the stories of patients once facing untreatable illnesses.

From development to commercialization – we’re by your side

Choosing a companion diagnostic (CDx) partner with a proven track record in IVD development is crucial for successful CDx–drug co-approval. Your CDx partner needs global regulatory capabilities coupled with global commercialization expertise through a Day-One lab readiness network.

We are uniquely positioned leaders in molecular CDx development. Our proven IVD development process delivers IVD solutions with multiple analytes and technologies. Furthermore, our longstanding commercialization expertise facilitates global registration success and optimal test access at drug approval – in any market.

Flexibility to meet pharma CDx needs

In the dynamic world of companion diagnostics, one size doesn’t fit all.

Our broad technology covers digital PCR (dPCR), real-time PCR and next generation sequencing (NGS). This provides real flexibility to tailor a CDx program to your needs, allowing you to select the right solution for your clinical trial program.

Together with a comprehensive launch-readiness framework and our global footprint in molecular labs, we will support you across the entire development process – from the idea through global commercialization.

Understanding the importance of Day-One testing

Patients cannot access a new drug if there is no companion diagnostic. And for some, when there are not many options left, this can be a matter of life and death.

With CDx testing at Day-One, physicians can find out if they’re eligible to access the treatment they need. Our comprehensive Day-One readiness program facilitates CDx testing at drug launch through our global network of partner labs.

Implementation and verification of a new test at our partner labs begin several months before CDx and drug approval. In parallel, we run a reimbursement program and align launch communications with our strategic partners to ramp-up testing in the shortest possible timeframe post-approval.

With our global presence, we can meet your country-specific commercial requirements .

The value of a Day-One lab network is even broader. Day-One labs can support:

Global commercialization

Our experience with regulatory authorities worldwide sets us apart. This means we can navigate the regulatory path, satisfy requirements and drive your success.

We want to work together with you to develop a commercialization strategy, from development through to launch – and easier access to testing.

Precision medicine
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stories from the field

Explore stories and testimonials from teams like yours showcasing the potential of these personalized treatments.