Thermo Fisher Scientific is to expand the use of its Oncomine Dx Target Test in clinical trials and drug development programmes after entering agreements with Daiichi Sankyo and Takeda Pharmaceuticals.
The expansion is in line with Thermo Fisher Scientific’s strategy to advance the test as a companion diagnostic (CDx) for a variety of therapies.
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The US Food and Drug Administration (FDA) approved Oncomine Dx Test to simultaneously report 23 genes clinically linked to non-small cell lung cancer (NSCLC).
From the 23 genes, three have markers that are approved for utility as a CDx for specific targeted treatments. The latest partnerships will focus on validating other biomarkers and gene variants.
Under the agreements, Thermo Fisher will retain global commercialisation rights for Oncomine Dx Test and will be responsible for all supplemental premarket approval (sPMA) filings to the FDA.
Thermo Fisher Scientific clinical next-generation sequencing and oncology president Joydeep Goswami said: “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.
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By GlobalData“This unique feature can help expedite their drug development programmes so that patients potentially benefit more quickly from the targeted therapies in the development pipeline.”
The company also signed a similar agreement with Spectrum Pharmaceuticals, which will employ the test as a CDx for its pan-HER inhibitor drug, poziotinib, being developed for NSCLC treatment.
Last year, the test was adopted by Agios Pharmaceuticals to detect IDH1 mutations in cholangiocarcinoma, and Blueprint Medicines to identify RET fusions in NSCLC patients.
