Pharma

Building upon a decade of CDx development for global commercialization


Advances in precision oncology have transformed cancer treatment, offering life-saving therapies to patients with limited options. However, the development of personalized medicine introduces significant challenges, as developers must develop companion diagnostics (CDx) tests alongside therapies so clinicians can match patients with the most appropriate treatment. For a successful global commercialization strategy, these challenges need strategic planning early in the development process.

Overcoming challenges in CDx development

Sample management

Tissue availability is a major bottleneck in CDx development. During clinical trials, samples are often sent to central labs for next-generation sequencing (NGS) testing, which can result in tissue loss. This is especially problematic when developers need those same samples for CDx development. Decentralized NGS technologies offer a solution, enabling local testing and potentially preserving valuable tissue samples for future use. NGS technologies that require substantial nucleic acid input can deplete samples quickly, posing risks to CDx assay development and validation.

Consistency and standardization

Variability across clinical trial sites can undermine the reliability of CDx assays. Laboratory-developed tests (LDTs) may differ in sensitivity and specificity, creating challenges for regulatory approval. Standardizing NGS technology across trial sites helps ensure consistency, and supports scalability, allowing for a seamless technology transition from clinical trials to CDx development.

Global regulatory navigation

Global commercialization of CDx requires navigating complex regulatory landscapes. Each region has unique requirements, and aligning with these diverse standards is no small feat. Partnering with an experienced diagnostic provider can streamline this process, helping to ensure that the CDx meets necessary criteria in target markets.

Setting up your program for success

Look ahead to CDx development and commercialization when selecting a solution for clinical trials

The journey from clinical trials to CDx development and commercialization is complex, and early decisions can significantly impact success. Decisions made during clinical trials have downstream implications for CDx development and commercialization. Choosing an end-to-end NGS provider ensures continuity from trial initiation through global launch.

Partner with proven experts

Experience matters. Selecting a partner with a demonstrated track record in CDx development is crucial. Experienced partners can help navigate regulatory landscapes. They can also anticipate and mitigate challenges and helping to ensure that programs stay on schedule and within budget.

Building upon a decade of innovation in CDx

The past ten years have marked a pivotal era in the evolution of companion diagnostics and the next decade promises even greater innovation. Building on innovations in genomics, NGS technologies, and regulatory strategies, CDx has evolved into a critical enabler of precision medicine. This decade of innovation has laid the groundwork for integrated, scalable, and globally accessible approach to CDx.

The Ion Torrent™ Oncomine™ Dx Target Test1 was the first distributable NGS-based CDx test approved in 2017 and has since expanded its label to include additional therapies, biomarkers, and global regions. The test is currently approved and reimbursed by government and commercial insurers in 19 countries, including the U.S., Japan, South Korea and countries across Europe and the Middle East, covering more than 550 million lives globally.

Looking ahead, the next chapter of innovation in CDx is here with the Ion Torrent™ Oncomine Dx Express Test2. Leveraging automation and speed of the Ion Torrent™ Genexus Dx System2, the Oncomine Dx Express Test can return NGS results in as little as 24 hours from tissue and liquid biopsies. With advanced automation, faster turnaround times, and streamlined workflows, this test can bring the power of NGS closer to patients, spanning drug development to CDx development and commercialization.

By embracing decentralized NGS technologies, developers can unlock the potential of CDx to enhance drug development, improve patient outcomes, and bring the promise of precision medicine to more people worldwide.

Thermo Fisher Scientific leverages their global infrastructure and expertise to provide widely used capabilities, from streamlining clinical research to accelerating targeted therapeutic and companion diagnostic development and global commercialization.

To learn more, visit us at oncomine.com/pharma.
 

  1. For In Vitro Diagnostic Use
  2. For In Vitro Diagnostic Use. Not available in all countries including the United States.


The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high-throughput, parallel sequencing technology to detect single-nucleotide variants (SNVs), insertions, and deletions in 23 genes from DNA and fusions in ROS1 and RET from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non–small cell lung cancer (NSCLC), IDH1 R132 mutations from FFPE tumor tissue samples from patients with cholangiocarcinoma (CC) and RET SNVs, MNVs, and deletions from DNA isolated from FFPE tumor tissue samples from patients with medullary thyroid cancer (MTC), and RET fusions from RNA isolated from FFPE tumor tissue samples from patients with thyroid cancer (TC) using the Ion PGM Dx System.

The Oncomine Dx Express Test is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing (NGS) technology and the Ion Torrent Genexus Dx System to detect deletions, insertions, substitutions, and copy number gain present in 42 genes and fusions in 18 genes from DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples. The Oncomine Dx Express Test also detects deletions, insertions and substitutions in 42 genes and fusions in 7 genes from cfTNA extracted from plasma samples. The Oncomine Dx Express Test is intended to provide clinically relevant tumor mutation profiling information to be used by qualified health care professionals in accordance with professional guidelines as an aid in therapy management of cancer patients with solid malignant neoplasms using FFPE samples and as an aid in therapy management of cancer patients with non-small cell lung cancer using plasma samples. It is not conclusive or prescriptive for labeled use of any specific therapeutic product.

The editorial staff had no role in this post's creation.