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Diagnostics Companion diagnostics

Precision Pathways

sponsored by Thermo Fisher Scientific

In the oncology space, as more and more targeted therapies are approved, it is all the more imperative that genetic testing technologies are available to connect patients with these treatments.

Collaborative companion diagnostics
 

Thermo Fisher Scientific is committed to helping expand the reach of precision medicine via close collaboration with biopharmaceutical partners to develop companion diagnostic (CDx) tests for their treatments. The co-development of CDx tests is designed to support the simultaneous regulatory submission of a therapeutic and a corresponding diagnostic. This process was designed to help ensure that a test is available to match patients with the new therapy as soon as it’s approved.

Reliable and rapid access to CDx for new therapies allows clinicians to quickly begin testing patients’ tumor samples and putting targeted therapies to use, which can be life-changing for patients who are a match.

Since 2017, when we launched Oncomine Dx Target Test*, the first next-generation sequencing (NGS)-based companion diagnostic approved by the US FDA, we have been focusing on expanding the indications and access to the testing worldwide. We have received regulatory approvals for nine CDx biomarkers for 17 therapies on label, for non-small cell lung cancer as well as thyroid cancer and cholangiocarcinoma. The test, with different indications per local regulatory approval, is now available in 18 countries across the globe. And we continue expanding further, working with both current and new pharma partners – in precision oncology it is all about the two industries working closely together.

Last year we launched the Oncomine Dx Express Test in Europe. This in vitro diagnostic CE marked test is used with the Genexus Dx System** to deliver clinically relevant tumor mutation profiling in as little as 24 hours. It utilizes a highly automated workflow from both formalin-fixed, paraffin-embedded tissue and plasma samples.

Bringing NGS in house, close to the patients
 

When test results are available early enough to inform a patient’s care, this can help to prevent the patient from being placed on a harsh and potentially ineffective treatment and instead help them be matched with the appropriate targeted therapy. Thermo Fisher Scientific and Integra Connect recently collaborated on a real-world study, presented during the 2023 American Society of Clinical Oncology Annual Meeting, which reiterated the importance of rapid genomic testing (1). The study, like others recently published, found that when genomic testing results were available early enough to inform a patient’s care, this had a positive impact on outcomes overall. With this in mind, we are continuously driven by the need to expand access to these testing technologies so more patients can benefit.

In the routine clinical world, targeted oncology treatments are guided by local multi-disciplinary teams. This is another reason to enable in-house access to genetic testing technology. However, the technologies used must be up to the challenge. The Genexus Dx Sequencer and Oncomine Dx Express Test rely on simple workflows so that minimal training is required to run tests, allowing this technology to be implemented in a broader spectrum of laboratories, with historically minimum resources for an NGS test.

Supporting precision medicine research
 

In precision oncology research, a broad spectrum of oncomine assays*** allows researchers to tailor their studies to the needs of specific labs and samples. With the fast turnaround times of these technologies, NGS results can be delivered at the same time as other single-gene testing methods. Thermo Fisher Scientific’s Ion Torrent Genexus system is the first NGS solution to automate the specimen-to-report workflow and delivers testing results in 24 hours.

Thermo Fisher Scientific is also committed to supporting and encouraging independent researchers who are working to expand the reach of precision medicine through the Oncomine Clinical Research Grant Program. In 2020, we launched this global initiative to support research projects investigating unmet diagnostic needs for next-generation sequencing-based testing. To date, the program has awarded 22 research proposals working across areas including solid tumors, hematology-oncology, immune-oncology and pediatric oncology. Awardees have spanned 14 countries on 5 continents.

*For in vitro diagnostics use.
**For in-house diagnostics use. CE IVD according to IVDD. Not available in all countries, including the United States.
***For research use only. Not for use in diagnostic procedures.

Thermo Fisher Scientific is a world leader in serving sciences who support customers who are accelerating life sciences research, solving complex analytic challenges, increasing productivity in their laboratories, and improving patient health through diagnostics or the development and manufacture of life-changing therapies.

The company has more than 100,000 employees worldwide through trusted brands which fall under the Thermo Fisher Scientific umbrella, including: Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

In our clinical sequencing division through our Oncomine product line, our goal is to provide simple and fast next-generation sequencing-based solutions for clinical research and routine patient testing that will help accelerate science, empower local care teams and bring the benefits of precision medicine to more patients.

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  1. J Scott, et al., JCO Oncology Practice, OP2200611 (2023). PMID: 37556776.
About the Author
Luca Quagliata

Vice-President, Medical Affairs, Clinical Next-Generation Sequencing Division, Genetic Sciences Group, Thermo Fisher Scientific

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