Spectrum Pharmaceuticals Enters into a Next-Generation Sequencing Companion Diagnostic Partnership with Thermo Fisher Scientific
Wednesday, May 02, 2018
Spectrum Pharmaceuticals, Inc., a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced it has entered into an agreement with Thermo Fisher Scientific to leverage the Oncomine™ Dx Target Test as a companion diagnostic for Spectrum’s novel pan-HER inhibitor, poziotinib, which is in development for the treatment of non-small lung cancer (NSCLC) patients with EGFR and HER2 exon 20 insertion mutations.
“Spectrum is committed to precision medicine for unmet medical needs in oncology,” said Tom Riga, Executive Vice President, Chief Operating and Commercial Officer of Spectrum Pharmaceuticals. “Thermo Fisher pioneered next-generation sequencing as the first multi-drug companion diagnostic for patients with non-small cell lung cancer when Oncomine™ Dx Target Test received premarket approval by the FDA in June 2017. Therefore, we believe Thermo Fisher will be an outstanding partner to help us advance the development of poziotinib. As promising clinical data continue to emerge with poziotinib for the treatment of patients with EGFR and HER2 exon 20 insertion mutations, the expansion of Oncomine™ Dx Target Test will aid in faster detection and future treatment of patients who are not well-served by currently available therapies.”
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 companion diagnostics, enabling physicians to match patients to three FDA-approved therapies in days instead of weeks. The test uses Thermo Fisher’s proprietary Ion PGM Dx sequencing platform to interrogate patient samples with high reproducibility and rapid turnaround times, even when limited tumor tissue is available.
Under the terms of the collaboration agreement, the goal of the expanded use of the Oncomine™ Dx Target Test is to identify NSCLC patients with EGFR or HER2 exon 20 insertion mutations who may be candidates for treatment with poziotinib in Spectrum’s global territories.
“We are pleased to partner with Spectrum Pharmaceuticals to help advance its drug development program and expand the clinical utility of Oncomine Dx Target Test,” said Joydeep Goswami, president of Clinical Next-Generation Sequencing and Oncology at Thermo Fisher Scientific. “We remain committed to help drive better health outcomes for patients who can benefit from targeted therapies more quickly.”
