FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple Non-Small Cell Lung Cancer Therapies Notes Thermo Fisher Scientific

HRS Scientific Sessions: Boston Scientific LBCT

During the Heart Rhythm Scientific Sessions this week, Boston Scientific announced positive LBCT data underscoring the safety and efficacy of multi-site pacing (MSP) over conventional cardiac resynchronization therapy (CRT), as well as poster presentations on real-world use of the WATCHMAN Left Atrial Appendage Closure (LAAC) device and next-generation WATCHMAN FLX LAAC device as alternatives to oral anticoagulation therapy for stroke risk reduction in patients with non-valvular atrial fibrillation.

What are the Most Commonly Performed Surgeries?

Whether you are trying to learn more about a surgery you are planning to have or find out what the most common procedures are, this list is here for you. Read more.

B2B Training: What’s the Most Effective Way of Learning?

B2B training, which is short for business-to-business training, is a popular and convenient type of training that enables entire companies to train their teams...

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.

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.