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Companion diagnostic (CDx) tests are powerful tools in precision medicine and help advance more widespread use of targeted cancer therapies. The U.S. Food Drug Administration (FDA) defines CDx as “essential for the therapeutic product’s safe and effective use.” Particularly when based on next-generation sequencing (NGS) technology, CDx tests help make therapeutic decision-making more precise, overall care less costly and, most importantly, potentially help cancer patients live longer, better quality lives. When used broadly and early, these tests can help ensure that patients receive the right treatment, right away.

The necessity and benefits of CDx to advancing precision medicine inherently suggests CDx and targeted therapy development should be closely aligned. In fact, the FDA has provided a regulatory framework to encourage co-development of CDx tests and targeted therapies.

For years, Thermo Fisher has worked closely with its biopharma partners, and in 2017 announced the first FDA-approved CDx for use in testing non-small cell lung cancer (NSCLC) patient samples, the Oncomine Dx Target Test. Since then, Thermo Fisher has secured regulatory approval for companion tests to enable the use of 11 targeted therapies in NSCLC and one targeted therapy in cholangiocarcinoma. Thermo Fisher currently provides the only globally distributable multi-biomarker NGS CDx solution that is approved and reimbursed by governments and commercial insurers in more than 15 countries, covering more than 550 million lives globally.

In 2021, Thermo Fisher gained FDA approvals for companion diagnostics developed with Servier Pharmaceuticals for Tibsovo in cholangiocarcinoma, and Eli Lilly and Company and Takeda Pharmaceuticals for selpercatinib and Exkivity in NSCLC. The Company also announced a multi-year global collaboration with AstraZeneca to develop companion diagnostics for targeted therapeutics in AstraZeneca’s precision medicine portfolio. Through this agreement, the two companies will co-develop CDx tests for use on the Ion Torrent Genexus System. Using this fully-integrated and automated NGS platform, pathologists will be able to provide clinicians with test results to guide potentially more effective patient treatment more rapidly.

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In the following Q&A, Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher, discusses the value of co-developing companion diagnostics and how broader access to these next-generation sequencing-based tests can advance precision medicine.

Garret Hampton
President of clinical next-generation sequencing and oncology
Thermo Fisher Scientific

Why are we seeing so much news about companion diagnostics now?

Garret Hampton: In 2020 alone, the FDA approved 20 new personalized drugs and biologics. As the Pharma and Biotech industry continues to develop more of these targeted therapies, it follows that we should see a corresponding increase in CDx development. The FDA and other regulatory bodies encourage co-development of the test with the drug, stimulating collaboration between pharma and diagnostics companies earlier and more often.

As the pipeline for targeted therapies becomes larger and countries establish new regulatory pathways to ensure access to these therapies, it is becoming increasingly important for pharmaceutical and diagnostics companies to work hand-in-hand to ensure access to precision medicine. Early and equitable access can improve outcomes at a population level, and that’s certainly newsworthy.

Just as biopharma companies are innovating to support targeted therapy development, so too are diagnostic companies. Advancements made to diagnostic technologies over the last several years are enabling more effective CDx development with the capability to read out many biomarker results at the same time. With sequencing equipment that is relatively easy to use because of increased automation and fully-integrated workflows, more patients can gain access to targeted sequencing results at their local hospitals.

If appropriate, they can be quickly matched with one or more of a growing pool of targeted treatments when timely decisions are critical to patient outcomes. This is of particular importance with diseases such as lung cancer or blood cancers which are often diagnosed in later stages with no time to waste before starting treatment.

"NGS is particularly well-suited for CDx applications because it enables multi-biomarker testing from a single patient sample so that a clinician can see if a patient is a match for one of many targeted therapies."

With an increasing number of approvals for NGS-based CDx tests, we’re also seeing increased adoption of this technology. NGS is particularly well-suited for CDx applications because it enables multi-biomarker testing from a single patient sample so that a clinician can see if a patient is a match for one of many targeted therapies. This multi-biomarker/multi-therapy approach is a unique value proposition that next-generation sequencing provides over other forms of testing.

What is the value of co-developing companion diagnostic solutions?

GH: In 2014, the FDA issued guidance entitled “In Vitro Companion Diagnostic Devices,” which encouraged the co-development of a companion diagnostic in concert with a targeted drug. Per the FDA, the clinical performance and clinical significance of the CDx should be established using data from the clinical development program of the targeted therapy.

The promise of precision medicine is not limited to the U.S.; the availability of new regulatory pathways in countries around the world is enabling biopharma to take a global approach to new drug launches. This means that new therapies and accompanying CDx tests will move through regulatory approvals in multiple countries, which creates new challenges, but also extends the potential reach of targeted therapies’ benefits more broadly and equitably.

It also highlights the need for broader partnerships with CDx providers whose tests are globally distributable and who have an established track record of approvals and registrations in several countries. Deep partnerships, like the one we recently announced with AstraZeneca, enable learnings on how to best share resources and accelerate development. This collaborative approach has become the foundation for our CDx partnerships at Thermo Fisher, in many cases allowing our CDx to receive approval with new targeted therapies simultaneously.

How can we increase patient access to this form of genetic testing?

GH: To identify patients who are eligible for new targeted therapies – and intervene early to increase likelihood of success – clinicians need early and easy access to the results from NGS-based tests. Today, most testing is centralized in large reference labs. To increase access to these tests, we need to ensure that smaller community hospitals can adopt NGS testing because it is financially viable and easy to use. This ultimately increases the amount of testing done where patients are diagnosed and treated.

The decentralization and democratization of NGS testing has been our vision and passion at Thermo Fisher by to simplifying the technology for use in clinical labs. We are in the early stages, however. As a community, we have to help generate the evidence for clinical utility and ensure that proximal access to patients brings the superior patient outcomes that we all hope for.

What barriers exist to match patients with these therapies?

GH: We certainly have made strides with the technical advances, but the clinical utility that I referred to above is essential to ensure that these tests are reimbursed.

As more studies are done, the evidence for NGS as an efficient and cost-effective CDx solution will mount. Ultimately, this data and support from patient advocacy groups and policymakers are what’s needed to build sustainable reimbursement models that reflect the true cost of care and the correlation with better, more equitable patient outcomes.

How can patients ensure they have access to this type of testing?

GH: For patients, information and advocacy are powerful tools. Advocacy groups that provide support, education, and tools, such as LUNGevity for lung cancers, are key to helping patients advocate for their care, enabling them to talk to their physicians about the value of targeted therapies and the tests that are needed to gain access to them.

The number of beneficial therapies has and will continue to increase, many of which require CDx tests. It’s no longer suitable to conduct one, or two, or three specific tests – patients need to be tested for all of the biomarkers that are relevant to their disease, simultaneously. The ultimate value of this is time: patients have been shown to do better overall if the first therapy they are treated with is the right therapy. If the treatment journey starts in the wrong place, the chances of a positive outcome decrease.

Ultimately, the healthcare system will provide more institutional support for precision medicine approaches such as NGS-based genetic testing – the opportunity for equity and economic benefit is compelling. As we see this future unfold, Thermo Fisher’s early collaboration with biopharma partners on a global scale will continue in earnest so the rising tide of discovery – from advances in NGS to promising new therapeutic targets – will lift us all as one.

For more information about Thermo Fisher’s companion diagnostics solutions, visit oncomine.com/pharma.