Oncoyte Corporation (NASDAQ: OCX) has signed a development and co-marketing collaboration deal for two distributed in vitro diagnostic assays in Thermo Fisher Scientific’s Ion Torrent Genexus System. The deal also gives Oncocyte the right to create future Genexus System companion diagnostics.
Collaboration clears the road of IVD approval.
As part of the collaboration, Oncocyte will clinically verify Thermo Fisher’s current Oncomine Comprehensive Assay Plus* on the Genexus System, clearing the road for IVD approval and prospective filings as a companion diagnosis. The >500-gene test, as an IVD, will first be able to offer doctors information regarding patients’ malignancies based on existing clinical information and suitable clinical studies, and prospective approval may aid in choosing tailored medicines. Also, Oncocyte will make its 27-gene expression DetermaIO test available as a Genexus distribution kit. Based on findings suggesting prospective pan-cancer applicability and enhancement over existing standard-of-care testing, DetermaIO may be able to predict responsiveness to immuno-oncology therapy.
CEO and president of Oncocyte Ron Andrews said, “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. 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.”
Collaboration to help expand IVD assays
“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.
