Complex Decisions.High Stakes.Delivered Collaboratively.
Biopharma success depends on getting critical diagnostic decisions right, from biomarker strategy to patient selection to global approval.
We support you as you navigate scientific and clinical complexity, from clinical development through regulatory approval and commercial launch.
1.
Your biomarker looks promising in preclinical data, but is the evidence strong enough to build a clinical program around it?
2.
Patient selection is where strategy meets reality. Are you identifying the patients most likely to demonstrate the benefit your therapy can deliver?
3.
Regulatory expectations vary across markets. Will your diagnostic strategy hold up across the FDA, PMDA, IVDR and the regulatory pathways you'll need for global launch?
You’re making high-stakes decisions under uncertainty, where scientific complexity, clinical realities, and regulatory expectations intersect. We work alongside your team to define and evolve diagnostic strategies as your program progresses. We combine clinically grounded judgment, adaptive ways of working, and rigorous regulatory execution to design diagnostic strategies that reduce complexities and strengthen drug development decision-making, towards optimizing patient outcomes.
Our diagnostic strategies are supported by a comprehensive portfolio of genomic tests and platforms deployed across the oncology lifecycle, from early risk assessment to monitoring and recurrence.
Before a biomarker can support a clinical program, it must withstand scientific, technical, and real-world variability.
We help you:
So you can move forward with confidence, knowing your biomarker is strong enough to support a clinical program.
If the right patients aren’t identified early, trials can fail to demonstrate therapeutic benefit.
So you can generate clear, clinically meaningful outcomes — and reduce the risk of missing endpoints or costly trial redesigns.
A diagnostic strategy that works in development may not withstand regulatory scrutiny or scale globally.
So your diagnostic strategy not only gets approved — but is also ready to scale with your therapy.
Scientific leadership
years of genetic testing leadership through Myriad Genetics
scientific publications
of BRCA1 and BRCA2 genes
Biopharma track record
biopharma development projects
clinical trials supported
biopharma partners
Regulatory success
FDA and PMDA approvals for companion diagnostics
commercially available CDx products
Laboratory Developed Test approved as CDx by the FDA
Strategic Partnerships
Sequencing platforms supporting comprehensive genomic profiling & IVD companion diagnostics
Development and global commercialization of IVD companion diagnostics
Development & global commercialization of LBx and tissue-based companion diagnostics
Development & commercialization of CDx for China
Our capabilities span multiple platforms, modalities, and development pathways, enabling flexible and scalable diagnostic strategies tailored to each program.
Proven tests supporting biomarker validation, patient selection, and clinical decision-making
Flexible platforms to support discovery, validation, and translational insights
End-to-end capabilities to support assay development and approval
Connect with our team to explore how to make the right diagnostic decisions at every stage of development.
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