Oncocyte Reports That Its First-Of-Its-Kind DetermaCNI Blood Test That Tracks Cancer Treatment Progress Could Hit Market By 2023

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Oncocyte Corp. OCX announced the publication of positive data last month showing the diagnostic potential of DetermaCNI, one of the leading cancer monitoring tests in its growing cancer diagnostics portfolio.

Oncocyte stated that the research showed the test was highly accurate in tracking treatment response in patients with ovarian cancer, adding more positive data that the company can use as it works to bring the test — currently the only blood-based test that is tumor independent for monitoring the efficacy of immunotherapies — to the broader market by early 2023.

Pharmaceutical Companies Investing In Immunotherapies As A New Leading Cancer Treatment?

Immunotherapies are reportedly becoming an increasing focus of researchers across the oncology space because they can provide more targeted, longer-lasting results for a wide range of cancers. Pharmaceutical giant AstraZeneca plc AZN, for example, made headlines last month after announcing successful Phase 3 results for Imfinzi, an immune checkpoint inhibitor to treat biliary tract cancers (in the gall bladder, liver, and bile ducts).

That same month, Keytruda, a monoclonal antibody treatment manufactured by Merck & Co. Inc. MRK, became the first immunotherapy to receive European Commission approval.

For patients undergoing immunotherapy treatments like these, the benefits of these novel drugs can be literally lifesaving. However, only about 13% of patients actually respond to the treatments. That’s an impressive response rate by cancer therapy standards, but it still means a lot of patients won’t benefit from these immunotherapy drugs or others in development.

Being able to accurately predict which patients are most likely to respond and then, during treatment, quickly detect whether the treatment is actually working against the cancer may be one key to making sure these promising new therapies get to the patients who can benefit from them most.

That’s where Oncocyte says it comes in. In January, the precision diagnostics company announced an agreement with Thermo Fisher Scientific Inc. to bring DetermaIO, a predictive blood test that identifies responders to immunotherapies prior to treatment, to market.

Now, it’s working to get DetermaCNI, its cancer progression blood test, on the market as soon as possible. Both of these are part of Oncocyte’s portfolio of tests that are meant to help doctors answer key questions like which treatment to give a patient, whether that treatment is working, and whether the patient’s cancer is coming back.

What Does DetermaCNI Do?

DetermaCNI uses a blood sample, rather than a biopsy, to detect changes in levels of circulating tumor DNA in blood plasma. Oncocyte reports that by taking a blood sample before treatment begins and then again after each cycle of therapy, doctors can track circulating tumor DNA levels throughout the course of treatment to figure out very quickly whether a therapy is working - without needing to take an invasive tissue sample from the patient or to run a very expensive genomic panel prior to monitoring.

Because the test can detect cancer progression early, after just one or two cycles of treatment, doctors may have the data they need to pivot quickly to a new treatment if the patient isn’t responding to the current one. This ability to react early and quickly is potentially crucial because so much of a patient’s prognosis hinges on being able to catch cancer early and begin an effective course of treatment as quickly as possible.

It may also give doctors the unique ability to test often. Taking a blood sample is much cheaper and much less invasive than taking a biopsy, so doctors can use DetermaCNI after each cycle of treatment. So long as the test shows that the treatment is yielding results, they can stay on course. Once the test shows the cancer is progressing, they can explore new options right away.

A study published in Cancer in January using the test to identify and monitor disease progression in patients with ovarian cancer reported that DetermaCNI showed 91% sensitivity (ability to detect disease in patients with the disease) and 95% specificity (ability to show negative results for patients who don’t have the disease). With such accuracy, the study concluded that the test is an important diagnostic tool for tracking and changing treatment plans to improve a patient’s outcomes.

“These data build upon a previous data set published in Clinical Cancer Research (Weiss et al.), which demonstrated the test’s high accuracy in predicting progression on immunotherapy treatment with a very high negative prediction,” Oncocyte President and CEO Ron Andrews said in a statement about the research.

The company says it is working to advance DetermaCNI from its current research use only status based on continuing evidence that displays its potential to identify progression early and with high accuracy. 

With the Centers for Medicare & Medicaid Services’ (CMS) recent decision to provide blanket reimbursement for these types of monitoring tests and the growing body of data showing the accuracy and diagnostic potential of DetermaCNI, Oncocyte hopes to bring the test to doctors by early 2023. 

This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. This test has not been cleared or approved by the US Food and Drug Administration.

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