FDA approves new diagnostic test for non-small cell lung cancer.
FDA has approved Thermo Fisher Scientific's Oncomine Dx Target Test, the first next-generation sequencing (NGS)-based companion diagnostic that can simultaneously screen for multiple therapies to treat non-small cell lung cancer (NSCLC).
According to the American Cancer Society, lung cancer is the leading cause of cancer death among both men and women in the United States, accounting for about 1 in 4 cancer deaths. Additionally, NSCLC makes up about 80% to 85% of all cases of lung cancer.
The Oncomine Dx Target Test simultaneously evaluates 23 genes clinically associated with NSCLC and results from the analysis of three of these genes can now be used to identify patients who may be eligible for treatment with FDA-approved therapies, including the combination of Novartis’ Tafinlar and Mekinist (dabrafenib and trametinib), Xalkori (crizitonib, Pfizer), or Iressa (gefitinib, AstraZeneca).
The Oncomine Dx Target Test provides a new testing method that saves time for the patient to get on the right therapy the first time and helps reduce overall healthcare costs associated with the guesswork that goes into the sequential testing approach when using single-biomarker tests,” said Joydeep Goswami, president of Clinical Next Generation Sequencing and Oncology for Thermo Fisher Scientific.
“The Oncomine Dx Target Test provides a new testing method that saves time for the patient to get on the right therapy the first time and helps reduce overall healthcare costs associated with the guesswork that goes into the sequential testing approach when using single-biomarker tests,” said Joydeep Goswami, president of clinical sequencing for Thermo Fisher Scientific.
The Oncomine Dx Target Test was developed in collaboration with Novartis and Pfizer and is based on Thermo Fisher’s Ion AmpliSeq technology, which enables screening of tumor samples using a very small quantity of preserved biopsy sample. Goswami explains that this is a critical advantage since samples from NSCLC patients are usually very limited in quantity.
“FDA approval of the Oncomine Dx Target Test is the first step in making precision oncology technology a reality; now, NSCLC patients and their oncologists have access to a molecular test that returns result in a few days,” said Goswami. “Rapid identification of a targeted therapy is crucial for these patients, who don’t have time to spare due to the late-stage of their cancer.”
Goswami said that Thermo Fisher plans to extend the test to include additional genes and submit to FDA so it can serve as a companion diagnostic for other indications beyond NSCLC.
The Oncomine Dx Target Test is expected to be available in the United States in August 2017.