Thermo Fisher Scientific Submits Premarket Approval Application to FDA for Next-Generation Sequencing-Based Oncology Test

Thermo Fisher Scientific (NYSE:TMO) today reports it has submitted a premarket approval application to the FDA concerning its Oncomine Universal Dx Test for non-small cell lung cancer.
According to the press release:

“If approved, the universal gene panel could be the first of its kind in the United States, and would serve as a companion diagnostic (CDx) utilized to select patients for specific NSCLC therapies. The test would also be accessible to global pharmaceutical companies for ongoing development of therapeutic drugs.”

Joydeep Goswami, president of clinical next generation sequencing at Thermo Fisher Scientific, said the following:

“As pharmaceutical companies shift toward developing new targeted therapies as opposed to ‘one-size-fits-all’ drugs, there is a clear need to more efficiently stratify cancer patients and tailor their treatments to enable better health outcomes. A companion diagnostic of this kind holds the promise to make precision medicine a reality.”

Read the full press release here.