NEW YORK (GenomeWeb) – Thermo Fisher Scientific said today that it has entered into a long-term agreement with Novartis and Pfizer to develop and commercialize a multi-marker, next-generation sequencing-based companion diagnostic test. The test will be used in conjunction with multiple drug development programs for non-small cell lung cancer.
Thermo Fisher will use its Ion PGM Dx system and Oncomine assays to develop the companion diagnostic. The Ion PGM Dx is listed with the US Food and Drug Administration as a Class II medical device, although the listing does not include analyzing somatic mutations from oncology samples.
The sequencing platform and assay make use of the Ion AmpliSeq technology, which requires as little as 10 ng of formalin-fixed paraffin-embedded tissue.
"We look forward to this collaboration and the future potential of this technology to further enhance the ability to connect patients to the right clinical trials and treatments for them, even those patients with less common tumor mutation types," Alessandro Riva, global of head oncology development and medical affairs at Novartis Oncology, said in a statement.
"The potential to generate a paradigm shift through this agreement — from one test for one drug, to one test for multiple NSCLC therapies, represents a significant step forward in realizing the promise of precision medicine," Mark Stevenson, president of life sciences solutions for Thermo Fisher Scientific, said in a statement.