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Thermo Fisher, Oncocyte Ink Development, Comarketing Deal for Cancer IVDs

NEW YORK – Cancer diagnostics firm Oncocyte said Tuesday that it has entered into a collaboration and comarketing agreement with Thermo Fisher Scientific for two cancer in vitro diagnostic tests.

Under the deal, the companies will work to clinically validate Thermo Fisher's existing Oncomine Comprehensive Assay Plus and to develop Oncocyte’s DetermaIO assay on the Ion Torrent Genexus system as in vitro diagnostics. 

According to a filing with the US Securities and Exchange Commission, the terms of the agreement — in effect until Dec. 31, 2035, unless terminated based on established measures — mandate that Thermo's subsidiary Life Technologies will retain the exclusive right to partner with pharmaceutical companies to develop its Oncomine test as a companion diagnostic. Oncocyte also keeps the exclusive right to partner with therapeutics companies to develop DetermaIO as a companion diagnostic.

Thermo Fisher will pay Oncocyte a percentage of revenue it receives on worldwide sales of a resulting Oncomine IVD test and on sales of the DetermaIO IVD outside the United States. Oncocyte's revenue share percentage will range from "the low teens to the low twenties" for the Oncomine test and the "low twenties" for the Determa assay, according to Oncocyte's SEC filing. 

Oncocyte will pay Thermo Fisher a "mid single-digit percentage of its revenue" on sales of the DetermaIO IVD product in the United States. The company will also receive up to two milestone payments "in the low seven figures" if Thermo is able to commercialize the Oncomine Plus IVD as a companion diagnostic "with certain claims." 

Thermo will be responsible for global commercialization of a resulting Oncomine IVD product, but the parties have agreed to comarket it in the United States, Canada, the United Kingdom, the European Union, Switzerland, Australia, and New Zealand. Oncocyte will be responsible for commercializing any DetermaIO IVD in the United States, while Thermo will be responsible for commercializing it in the rest of the world.

Oncocyte CEO Ron Andrews said in a statement that the firm has designed its full suite of Determa tests to "ultimately become regulated kits for distribution" on an IVD instrument. The firm's collaboration with Thermo Fisher is a move to enable that vision. 

"As many as 44 [percent] 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," Andrews said. "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."

Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher, said that the partnership will help his firm meet its own goals of expanding access to genomic profiling and spreading the benefits of precision medicine to more patients. 

In its SEC filing, Oncocyte outlined that the companies are sharing some development costs but retain their own costs for certain development activities. 

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