Connect with our team to design diagnostic strategies that meet regulatory expectations and support successful global deployment.
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Without the right approach, a diagnostic strategy that works in development may not meet regulatory expectations or translate into real-world use — risking delays, rework, or failure at the final stages.
We partner with you to design diagnostic strategies built for approval and ready to scale globally.
Demonstrating clinical benefit is only part of the challenge.
It must also align with regulatory expectations and translate into real-world global markets.
We help you bridge the gap between clinical evidence and approved, deployable diagnostic solutions.
We combine regulatory expertise, CDx development capabilities, and global partnerships to ensure your diagnostic strategy is not only approved but successfully implemented in real-world settings.
A diagnostic strategy must meet regulatory expectations not just scientific ones.
We help you:
So your diagnostic strategy is built for approval, not retrofitted later
Regulatory expectations vary across regions, creating complexity for global programs.
So you can move efficiently from development to approval across global markets
Approval is only the first step, successful deployment requires global scale.
So your diagnostic strategy is ready for real-world use at scale
Translating clinical validation into global deployment is one of the most critical challenges in CDx development.
We design integrated CDx deployment strategies that combine centralized testing and kit-based approaches, ensuring both scientific rigor and global scalability.
For example:
This integrated approach enables faster trial enrollment, reduces development and bridging risk, and supports scalable global deployment aligned with regulatory expectations and commercialization pathways.
While every program is different, the underlying decision framework is consistent: when to prioritize speed and control, when to invest in scalability and global reach, and how to manage risk across development stages.
By aligning testing models to each phase of development, we help biopharma teams make more informed decisions across development:
Most CDx programs follow a sequential path, delaying global readiness and increasing risk. We take a different approach:
This parallel approach reduces time to approval, mitigates bridging risk, and enables flexible global deployment from the outset.
We have a proven track record of translating diagnostic strategies into approved and commercially successful solutions.
Our experience includes the development of FDA-approved CDx that support real-world clinical decision-making.
HRD Companion Diagnostic Test
Determines homologous recombination deficiency (HRD) status for patients with ovarian cancer using MyChoice CDx, the first and only FDA-approved, NGS-based IVD tumor test
Germline Companion Diagnostic Test
Identifies patients with deleterious or suspected deleterious mutations in BRCA1 or BRCA2 genes who may be eligible for certain targeted therapies, the first and only FDA-approved CDx test of its kind
We collaborate with leading diagnostic and technology partners to extend our capabilities across platforms, technologies, and geographies to support global CDx execution.
Our ecosystem enables:
Distributable CDx solutions
Global clinical trial access
Multi-platform assay development
Enables development of CTA and CDx assays across NGS, PCR, and dPCR technologies, including kit-based versions of HRD and MyChoice CDx, supporting both centralized and distributed testing strategies.
Supports development of distributable kit versions of MyChoice® HRD and enables comprehensive genomic profiling through TSO500, facilitating global clinical trial testing and scalable deployment.
Enables localized testing and regulatory alignment in China, supporting patient enrollment and access in one of the most critical global markets.
Enables scalable, decentralized testing through a global network and advanced NGS platforms.
A strong diagnostic strategy must do more than support development; it must hold up under regulatory scrutiny and work in real-world clinical settings — so you can move from clinical success to global impact.