Oncocyte Corporation (Irvine, CA, USA) has entered into a development and co-marketing agreement for two distributed in vitro diagnostic (IVD) assays on Thermo Fisher Scientific’s (Waltham, MA, USA) Ion Torrent Genexus System. The agreement also grants Oncocyte rights to develop future companion diagnostics on the Genexus System.
The first-of-its-kind Genexus System is designed to be used in any lab and delivers comprehensive next-generation sequencing (NGS) results in as little as a single day – the same timeframe as single-gene tests, such as immunohistochemistry (IHC) assays. The Genexus system’s flexible batching makes it an attractive solution for hospital labs with low and medium testing volume by reducing the need to wait several days until a lab has a sufficient number of samples to test. The integrated purification system and sequencer enable sample preparation and processing with only 20 minutes of hands-on time and minimal user intervention, allowing for the democratization of NGS to community and regional cancer centers globally.
Under the terms of the collaboration, Oncocyte will clinically validate Thermo Fisher’s existing Oncomine Comprehensive Assay Plus on the Genexus System, paving the way toward IVD clearance for use in tumor profiling and future submissions as a companion diagnostic. As an IVD, the >500-gene assay will initially be able to provide physicians with information about patients’ tumors in accordance with established clinical evidence, applicable clinical trials, and future approval may assist with the selection of targeted therapies. Oncocyte will also develop its 27-gene expression DetermaIO test as a distributed kit on the Genexus. DetermaIO may predict response to immuno-oncology therapies based on data demonstrating potential pan-cancer utility and improvement over current standard-of-care tests.
“As many as 44% of newly diagnosed cancer patients may be eligible for immuno-oncology therapies, with additional patients potentially benefiting from other precision medicines, yet many patients’ tumors are never sequenced to determine if they may benefit from these targeted treatments,1” said Ron Andrews, President and Chief Executive Officer of Oncocyte. “In order to increase the number of patients benefiting from precision medicine, we need to expand the number of IVDs and develop these tests on instruments that are designed to make sequencing-based testing simple and more accessible. We have developed our Determa menu to ultimately become regulated kits for distribution ex-US on an IVD instrument. Our collaboration with Thermo Fisher using the Genexus System’s end-to-end automation enables that vision.”
“Leveraging Thermo Fisher’s proven global capabilities and installed base will enable us to expand the availability of IVD assays beyond the US. market. The collaboration with Thermo Fisher, along with the resulting IVD test kits and potential companion diagnostic tests that we will seek to develop and market together, will play a key role in helping us improve patient outcomes worldwide,” added Andrews.
“Genomic testing can have a dramatic impact on patient care, especially when results are available quickly to support early clinical decision-making,” said Garret Hampton, President, clinical next-generation sequencing and oncology at Thermo Fisher Scientific. “Today, access to comprehensive testing depends on where you are treated. Our goal is to democratize genomic profiling so it is available to patients right away in more clinical settings – ultimately, everywhere patients receive treatment. By partnering with Oncocyte to validate and co-develop new IVD assays, we are working to expand access to genomic profiling and spread the benefits of precision medicine to more patients.”