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Companion Diagnostic Will Support NSCLC Clinical Trials

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Thermo Fisher Scientific and Janssen Research & Development recently announced a collaboration to co-develop a companion diagnostic for non-small cell lung cancer (NSCLC). The collaboration marks the first in a line of upcoming companion diagnostic deals for Thermo Fisher Scientific and will involve the validation of multiple biomarkers for use with its Oncomine Dx Target Test.

To learn more about the collaboration and some of the ways that companion diagnostics can benefit oncology patients,
Technology Networks spoke to Dr Luca Quagliata, Global Director of Medical Affairs for Clinical NGS and Oncology at Thermo Fisher Scientific.

Anna MacDonald (AM): Can you give us an overview of what a companion diagnostic is?

Quagliata (LQ): With the advance of precision medicine, clinicians can now match the right person with the right therapy more efficiently and weigh potential risks and side effects against tangible clinical benefits. Companion diagnostics enable clinicians to identify which patients are more likely to benefit from a given therapy. Diagnostic companies like Thermo Fisher are working closely with the pharmaceutical industry to develop companion diagnostics for many of the targeted therapies available to patients today. In fact, the vast majority of the latest targeted therapies approved by the U.S. Food and Drug Administration (FDA) received clearance along with a defined companion diagnostic test. In most cases those tests work by assessing the status of a specific molecular biomarker, for example the presence of a BRAF mutation, to determine if a patient is a candidate for a targeted therapy addressing that mutation.

AM: What benefits do companion diagnostics offer patients?

Companion diagnostics connect patients to the right therapies, faster. The results generated via a companion diagnostic test allow clinicians to prescribe specific drugs (in label drug use), reassuring the best possible therapy match for the patient. Thus, a companion diagnostic-based approach can minimize the possibility of non-effective therapies, sparing patients unnecessary lines of treatment that may come with associated side effects. In addition, studies have shown that starting patients on appropriate targeted therapies earlier can improve outcomes.

AM: Can you tell us a little about the Oncomine Dx Target Test?

The Oncomine Dx Target Test is the first next-generation sequencing (NGS) in vitro diagnostic approved by the FDA as a companion diagnostic for NSCLC. The test enables certified laboratories to generate a comprehensive genomic profile of a patient’s tumor within a few days. It is able to test for 46 cancer-related biomarkers all at once and with the lowest input sample requirements on the market. The Oncomine Dx Target Test provides the clinical care team with the information needed to match the patient to the right treatment. Lung cancer is typically asymptomatic until later stages and many patients are diagnosed at stage III or IV, so matching patients with the right therapy quickly is crucial.

Since its approval by the FDA, Thermo Fisher has partnered with multiple pharmaceutical companies to expand the clinical utility of the Oncomine Dx Target Test for a number of drug development programs and clinical trials. These partnerships are designed to leverage the Oncomine Dx Target Test for indications outside of NSCLC.

AM: How will the test be used as part of the collaboration with Janssen?

In collaboration with the Janssen Research & Development Team, we are working to co-develop a companion diagnostic using the Oncomine Dx Target Test to support enrollment in clinical trials around the world. Through the collaboration we will validate multiple biomarkers that will be used to identify patients who may be eligible for NSCLC-focused clinical trials. In the future, the development program could expand to include additional indications in oncology.

AM: What are the advantages of using NGS panel testing over single-gene testing?

Single-gene tests typically offer limited information. When they are applied sequentially, it delays the time - often by several weeks - it takes to receive a comprehensive genomic profile of a patient’s tumor. As a direct consequence, patients must wait longer before they are placed on an appropriate treatment regimen. In contrast, NGS panel testing enables clinicians to obtain a more comprehensive picture of a patient’s genomic profile with just one test so the clinical care team can make a more informed therapy selection from the very beginning.

Up until recently, many community and hospital-based laboratories considered comprehensive molecular profiling too costly or complex to handle it in-house. Instead, these laboratories have relied on limited single-gene testing or turned to outsourced testing for NGS analysis, which can also create a lag of several weeks for test results to be returned. With the availability of cost-effective, simple-to-use NGS solutions, however, many community hospitals and government healthcare agencies are starting to consider in-house NGS testing. This shift, aiming to reduce the critical time between testing and treating, is a major step forward to realize the promise of precision medicine and, ultimately, providing better outcomes for patients.

Quagliata was speaking to Anna MacDonald, Science Writer, Technology Networks.