Oncocyte (NSDQ:OCX) announced yesterday that it entered into a development and co-marketing agreement with Thermo Fisher Scientific (NYSE:TMO).
The development and co-marketing agreement covers two distributed in vitro diagnostic (IVD) assays on Thermo Fisher’s Ion Torrent Genexus system and grants Oncocyte the rights to develop future companion diagnostics on the Genexus system.
Under the collaboration terms, Oncocyte will clinically validate Thermo Fisher’s existing Oncomine Comprehensive Assay Plus on the Genexus system to accelerate it toward IVD clearance for use in tumor profiling and future submissions as a companion diagnostic, according to a news release.
The 500-gene assay could initially provide physicians with information about tumors in accordance with established clinical evidence, Oncocyte said.
Oncocyte will also develop its 27-gene expression DetermaIO test as a distributed kit on Thermo Fisher’s Genexus platform. DetermaIO may predict response to immuno-oncology therapies based on data demonstrating potential pan-cancer utility and improvement over current standard-of-care tests, according to Oncocyte.
“Leveraging Thermo Fisher’s proven global capabilities and installed base will enable us to expand the availability of IVD assays beyond the U.S. market,” Oncocyte President & CEO Ron Andrews said in the release. “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.”
Thermo Fisher designed its Genexus system for use in any lab to deliver comprehensive, next-generation sequencing results in as little as one day. It features flexible batching and an integrated purification system and sequencer that enable sample preparation and processing with only 20 minutes of hands-on time and minimal user intervention.
“Genomic testing can have a dramatic impact on patient care, especially when results are available quickly to support early clinical decision-making,” Thermo Fisher President of Clinical Next-Generation Sequencing & Oncology Garret Hampton said. “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.”
Needham analyst Mike Matson lists Oncocyte as a “Buy” on the back of the news, citing the agreement with Thermo Fisher as “a long-term positive” for Oncocyte as it should provide opportunities to generate additional revenue that are complementary to its current U.S. lab-developed test offering.
However, shares of OCX were down 16.5% at $1.83 per share in late-morning trading today.