Picture Berlin Partner HealthCapital Bionnale 2018 Germany June 600x60px
Document › Details

Thermo Fisher Scientific Inc.. (6/22/17). "Press Release: FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple Non-Small Cell Lung Cancer Therapies". Carlsbad, CA.

Region Region United States (USA)
Organisations Organisation Thermo Fisher Scientific Inc. (NYSE: TMO)
  Group Thermo Fisher (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Product Product  Tafinlar®
Index term Index term Novartis–Thermo Fisher: molecular companion diagnostics, 201511– collab developm NGS-based CDx for NSCLC with Pfizer
Person Person Minotta, Mauricio (Thermo Fisher 201511)

Oncomine Dx Target Test returns results in days, helping physicians rapidly develop treatment plans for the most common form of lung cancer

The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing (NGS)-based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non-small cell lung cancer (NSCLC). Lung cancer is the leading cause of cancer-related deaths in the U.S., with NSCLC accounting for 85 percent of all lung cancers.1

The Oncomine Dx Target Test simultaneously evaluates 23 genes clinically associated with NSCLC. Following FDA approval, results from analysis of three of these genes can now be used to identify patients who may be eligible for treatment with one of the following: the combined therapy of Tafinlar® and Mekinist®, XALKORI®, or IRESSA®. With this test, physicians can now match patients to these therapies in days instead of several weeks, which it often takes when screening samples one biomarker at a time.

"For people battling non-small cell lung cancer, time is critical and days matter," said Joydeep Goswami, president of clinical next-generation sequencing and oncology at Thermo Fisher. "The Oncomine Dx Target Test rapidly guides oncologists toward the right targeted therapy, with the goal of improving patient outcomes and the cost-efficiency of treatments."

LabCorp's Diagnostics and Covance Businesses, NeoGenomics Laboratories, and Cancer Genetics, Inc., are among the first laboratories that will offer the Oncomine Dx Target Test as a service to oncologists. All tests will be run on Thermo Fisher's Ion PGM Dx System, which received FDA 510(k) clearance in parallel for use on formalin-fixed, paraffin-embedded (FFPE) tissue samples.

"This first iteration of the test is just the beginning since the diagnostic claims of the Oncomine Dx Target Test may be expanded in the future based on the existing panel," Goswami added. "Thermo Fisher has entered into discussions with several pharmaceutical companies looking to use the panel for FDA-approved targeted therapy applications beyond lung cancer. Expanding the range of clinically actionable information is part of the company's goal to help our customers advance precision medicine."

Thermo Fisher developed the Oncomine Dx Target Test in collaboration with Novartis and Pfizer. It is based on Thermo Fisher's Ion AmpliSeq technology, which enables screening of tumor samples for multiple genetic markers with 10 nanograms of nucleic acid. Returning results using such a small amount of FFPE material is a critical advantage of the test since samples from patients with NSCLC are often limited in quantity.

More information about the Oncomine Dx Target Test is available at

Tafinlar® and Mekinist® are registered trademarks of Novartis; XALKORI® is a registered trademark of Pfizer; and IRESSA® is a registered trademark of AstraZeneca.

1. Non–Small Cell Lung Cancer: Epidemiology, Risk Factors, Treatment, and Survivorship; Julian R. Molina, MD, PhD, Ping Yang, MD, PhD, Stephen D. Cassivi, MD, Steven E. Schild, MD, and Alex A. Adjei, MD, PhD

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $18 billion and more than 55,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit

Media Contact Information:

Mauricio Minotta, Thermo Fisher Scientific
+1 760 929 2456
+1 760 805 5266 (mobile)


Maurissa Messier, CG Life
+1 908 208 9254

If you have any questions regarding this Press Release, please email us at

Record changed: 2018-03-03


Picture Fairtec GmbH We Optimise the ROI of Your Event 600x60px

More documents for Thermo Fisher (Group)

To subscribe to our free, monthly newsletter for the European life sciences, please send an e-mail to and simply fill the subject line with the word »LSE newsletter«

To get even more information, please take a look at our [gs] professional services offering and read the gene-sensor Product Flyer [PDF file]


Picture Berlin Partner HealthCapital Bionnale 2018 June Matchmaking 600x60px

» top


Picture [iito] Twitter iitoLifeScience Life Sciences Mass Spec 120x120px Picture Berlin Partner HealthCapital Bionnale 2018 June Matchmaking 120x240px Picture [LSE] – The Business Web Portal 120x600px Picture Berlin Partner HealthCapital Bionnale 2018 Germany June 120x240px Banner Fairtec GmbH Solutions for Smarter Business Events Exhibitions 120x120px Picture [iito] Twitter iitoLifeScience Life Sciences Mass Spec 120x120px