Thermo Fisher will retain global commercialization rights for the test and will lead all filings of supplemental premarket approvals (sPMA) in order to seek approval from the U.S. FDA. Expansion of Oncomine Dx Target Test is part of the company’s strategic plan to further develop its test as a companion diagnostic (CDx) for multiple therapies.
“We are extremely pleased with the strong interest and commitment from our pharmaceutical partners who see the value of leveraging the expandability of Oncomine Dx Target Test,” said Joydeep Goswami, president of Clinical Next Generation Sequencing and Oncology at Thermo Fisher Scientific. “This unique feature can help expedite their drug development programs so that patients potentially benefit more quickly from the targeted therapies in the development pipeline.”
Oncomine Dx Target Test is FDA approved to simultaneously report 23 genes clinically associated with NSCLC. Of those 23, three contain markers that are approved for use as a CDx for specific targeted therapies.