Thermo Fisher said it will expand the use of its Oncomine Dx Target Test as a companion diagnostic through newly-signed agreements with Daiichi Sankyo and Takeda Pharmaceuticals.

The agreements—whose value was not disclosed—will focus on validating additional biomarkers and gene variants for the precision oncology assay, thus increasing its clinical utility, Thermo Fisher said.

Under the agreements, Thermo Fisher will retain global commercialization rights for Oncomine Dx Target Test, and will lead all filings of supplemental premarket approvals (sPMA) with the FDA.

Thermo Fisher said the agreements align with its strategic plan, which calls for further developing Oncomine Dx Target Test as a companion diagnostic (CDx) for multiple therapies.

Thermo Fisher has multiple active sPMA programs designed to expand Oncomine Dx Target Test, including an initiative to add the ALK gene, which is nearing completion—and a separate agreement announced Tuesday by Spectrum Pharmaceuticals to use Oncomine Dx Target Test as a CDx for Spectrum’s novel pan-HER inhibitor, poziotinib, which is being developed to treat non-small lung cancer (NSCLC) patients with EGFR and HER2 exon 20 insertion mutations.

Oncomine Dx Target Test is FDA-approved to simultaneously report 23 genes clinically associated with NSCLC. Three of the 23 genes contain markers that are approved for use as a CDx for specific targeted therapies.

Oncomine Dx Target Test has also been adopted for use by several national reference laboratories, including LabCorp's Diagnostics and Covance businesses, Quest Diagnostics, Cancer Genetics, and NeoGenomics Laboratories.

And 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 nation’s largest commercial health insurers, including CIGNA, Aetna, UnitedHealthcare and the Centers for Medicare and Medicaid Services. As a result, the test is now available to more than 160 million lives in the U.S., according to Thermo Fisher.  

Last year, the company entered into CDx agreements with Agios Pharmaceuticals 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).

“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,” Joydeep Goswami, president of Clinical Next Generation Sequencing and Oncology at Thermo Fisher, said Tuesday in a statement. “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.”

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