Thermo Fisher Scientific announced today it has signed new agreements with Daiichi Sankyo and Takeda Pharmaceuticals designed to expand the clinical utility of Oncomine Dx Target Test in support of clinical trials and drug development programs at each of the firms. The agreements will focus on validating additional biomarkers and gene variants on the test and support Thermo Fisher’s commitment to further enable precision oncology.
Under the terms of the agreements, 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 FDA. Expansion of Oncomine Dx Target Test aligns with 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.”
To date, Thermo Fisher has multiple active sPMA programs in place to expand Oncomine Dx Target Test, including an agreement announced today by Spectrum Pharmaceuticals, and another to add the ALK gene, which is nearing completion. The company entered into CDx agreements with Agios Pharmaceuticals last year to validate the test to identify IDH1 mutations in cholangiocarcinoma patients, and with Blueprint Medicines to identify RET fusions in non-small cell lung cancer (NSCLC).
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. It has also been adopted for use by several national reference laboratories, including LabCorp’s Diagnostics and Covance businesses, Quest Diagnostics, Cancer Genetics, Inc., and NeoGenomics Laboratories.
Since receiving FDA approval last year, Oncomine Dx Target Test has received positive reimbursement decisions from the Centers for Medicare and Medicaid Services and from the country’s largest commercial health insurers, including CIGNA, Aetna, UnitedHealthcare and the Centers for Medicare and Medicaid Services—making the test available to more than 160 million lives in the United States.
(Source: Thermo Fisher Scientific)