Thermo Fisher earned FDA premarket approval for its companion diagnostic that screens tumors for biomarkers associated with three non-small cell lung cancer (NSCLC) treatments and can help identify patients who are suitable for treatment with one of these therapies.
The Oncomine Dx Target Test is the first companion diagnostic that simultaneously assesses a patient’s eligibility for treatment with multiple NSCLC therapies, Thermo Fisher said in a statement.
The test, which evaluates 23 genes associated with NSCLC, may be used to determine which patients would benefit from treatment with Pfizer’s Xalkori, AstraZeneca’s Iressa, or Novartis’ combo treatment, Tafinlar and Mekinist.
Other companion diagnostics, such as Roche’s test for Xalkori, evaluate tumors one biomarker at a time. Because it evaluates tumors for responsiveness to three treatments simultaneously, the Oncomine test can cut down the amount of time it takes to match patients to therapies. Physicians may be able to do this in days rather than several weeks, Thermo Fisher said.
"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."
Lung cancer is the second most common cancer and the leading cause of cancer death in the U.S. But the company isn’t stopping here.
"Thermo Fisher has entered into discussions with several pharmaceutical companies looking to use the panel for FDA-approved targeted therapy applications beyond lung cancer," Goswami added. "Expanding the range of clinically actionable information is part of the company's goal to help our customers advance precision medicine."