Oncocyte And Thermo Fisher Report Teaming Up To Bring Precision Medicine To Cancer Patients Worldwide

Image provided by Thermo Fisher Scientific Inc.

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Last month, Oncocyte Corp. OCX announced an agreement with Thermo Fisher Scientific Inc. to develop and comarket two in vitro diagnostic assays that provide more comprehensive, accurate genetic sequencing of tumors. The more complete genetic profile may give doctors the data they need to personalize treatment plans by identifying the cancer therapies that each patient is most likely to respond to.

Through the agreement, Oncocyte will be able to develop its DetermaIO™ test on Thermo Fisher’s Ion Torrent Genexus System, a next-generation sequencing system that can deliver results in as little as a single day whereas other tests may take several weeks (and only requires 20 minutes of hands-on time for the lab tech running the diagnostics). 

Oncocyte is a precision diagnostics company with a mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey.  The agreement could help the company bring its diagnostic tools, including its proprietary DetermaIO gene expression test, to more cancer patients around the world.

Are Better Diagnostics Needed To Drive Cancer Treatment Decisions?

As more and more checkpoint inhibitor drugs are being approved by the Food and Drug Administration (FDA) for a wider range of cancers, the fraction of patients eligible grew from less than 2% in 2011 to nearly 44% in 2018. 

However, only an estimated 15% of patients respond to these immuno-oncology drugs. While that’s considered a good response rate — genome therapies, as a comparison, are also considered an exciting new cancer therapy but have a response rate of less than 2% — it still means that most eligible patients won’t respond to the treatment. Not to mention that even though these drugs are incredibly effective for those who do respond to them, they can also carry severe side effects.

Because of this response rate, doctors arguably need a way of accurately predicting which patients will fall into that 13% so that those who would benefit can begin the treatment as soon as possible. Additionally, helping those who wouldn’t respond avoid wasting precious treatment time (and money) on a therapy that has difficult side effects that’s unlikely to help. 

To provide that kind of precision medicine, many argue that better diagnostics are needed as the current standard is not as predictive in identifying treatment. That could mean as many as 1 in 6 patients likely to respond are passed over for treatment. It can also lead to false positives, misidentifying patients as likely responders when they actually aren’t. With costs as high as $300,000 per patient for the treatment, that’s not a false positive most patients can afford.

DetermaIO Aims To Offer More Accurate Predictions

With DetermaIO, Oncocyte states that it has created a more comprehensive gene expression test that looks at 27 genes, making up the entire tumor immune microenvironment (TIME). It’s the first and only test to measure the entire TIME, so it provides a more precise understanding of the tumor’s readiness to respond to Immunotherapy.

In a study comparing the test to the PD-L1 test that is the current standard, DetermaIO outperformed the standard, both in identifying likely responders that the PD-L1 test missed and in ruling out unlikely responders that the standard test misidentified as candidates for immunotherapy.

Currently, the test is in the early adopter phase of market launch and applying the test to Thermo Fisher’s Genexus instrument should allow for wider distribution. Oncocyte is looking to make sure patients in every community in the US and Europe will have access as their doctors work to select the most appropriate therapy.

This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice.  In addition, the DetermaIO test was developed by Insight Genetics, a CAP-accredited, wholly owned subsidiary of Oncocyte.  This test is offered out of Oncocyte’s Clinical Laboratory Improvement Amendments (CLIA) licensed laboratory. This test has not been cleared or approved by the US Food and Drug Administration.