Oncocyte Presents Confirmatory Data for DetermaIO™ at the American Association for Cancer Research Annual Meeting 2022

Rhea-AI Summary

Oncocyte Corporation (Nasdaq: OCX) announced findings from a real-world cohort study demonstrating that its DetermaIO test can effectively predict responses to immunotherapy in patients with bladder cancer. The study validated the test's capacity to identify responders to immune checkpoint inhibitors (ICIs) and confirmed previous results from the IMvigor210 trial. DetermaIO, launched in Q4 2021, assesses the tumor microenvironment, providing critical insights that could improve patient treatment decisions and outcomes. The findings were presented at the AACR Annual Meeting 2022.

Positive

• DetermaIO confirmed as an effective predictor for immunotherapy response in real-world bladder cancer patients.
• Second independent mUC cohort study validates DetermaIO's results with established algorithms.
• Potential to improve treatment decisions for patients with metastatic urothelial cancer (mUC).
• DetermaIO demonstrated complementary predictive ability alongside tumor mutational burden (TMB).

Negative

• None.

Real-world cohort shows commercially available clinical test, DetermaIO, can predict response to immunotherapy and inform therapeutic decisions for patients with bladder cancer

IRVINE, Calif., April 11, 2022 (GLOBE NEWSWIRE) -- Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company with the mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey, today will present data at the American Association for Cancer Research (AACR) Annual Meeting 2022. The data is from a real-world cohort of patients with bladder cancer or metastatic urothelial cancer (mUC) and confirms the association of results from the Company’s DetermaIO™ test with response to treatment with immune checkpoint inhibitors (ICI). Notably, this is the second independent mUC cohort to show the capability of DetermaIO to identify ICI responders using the same algorithm and threshold previously established and validated in bladder and other tumor types.

The poster presented, titled “Confirmatory study of the IO Score, a tumor immune microenvironment (TIME) classifier, demonstrates efficacy in a real-world cohort of metastatic urothelial cancer (mUC) patients treated with immune checkpoint inhibitors (ICIs),” sought to confirm results from the IMvigor210 trial and identify a more accurate predictor of response to ICIs in mUC to better direct patients to appropriate therapy earlier in treatment. Investigators met both objectives, confirming the IMvigor210 trial in a real-world cohort of patients with mUC and showing that DetermaIO is independent and complementary to tumor mutational burden (TMB), a commonly used method biomarker, in predicting response to ICI. This suggests that a DetermaIO/TMB model may be a useful biomarker when weighing multiple treatment options.

“We have achieved our goal to expand the IMvigor210 findings of the DetermaIO’s utility as a biomarker for ICI efficacy in bladder cancer and now have real-world data in this tumor type which adds to the growing amount of evidence supporting our DetermaIO test,” said Tyler Nielsen, lead author on the poster at Oncocyte and the lead author of the poster. “With fewer than 10% of patients with metastatic urothelial cancer surviving two years after diagnosis, we believe that the potential insights unlocked by this test can impact treatment decisions earlier and hopefully improve patient outcomes.”

DetermaIO has previously been shown to identify patients who respond to immunotherapy in lung, bladder, kidney, and triple-negative breast cancers across four approved immunotherapies - Keytruda^®, Opdivo^®, Tecentriq^® and Imfinzi^® - suggesting a pan-cancer utility in both primary and metastatic settings. In this confirmatory study, patients were treated with all four agents and DetermaIO identified responders, regardless of which agent the patients received. The test was launched for clinical use in Q4 of 2021 and is the first and only test to measure the entire tumor microenvironment (TME). By evaluating the TME as a whole, the test can help identify patients primed to respond to immunotherapy and patients who may not respond as well, allowing physicians and their patients to make informed decisions about their treatment journey.

About Oncocyte
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. Through its proprietary tests and pharmaceutical services business, the company aims to help save lives by accelerating the diagnosis of cancer and advancing cancer care. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients at every stage. DetermaRx™ identifies early-stage lung cancer patients who are at high risk for cancer recurrence and who may benefit from adjuvant chemotherapy. DetermaIO™, a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies. The Company’s pipeline of tests in development also includes DetermaTx™, which will assess mutational status of a tumor, blood-based monitoring test DetermaCNI™, and long-term recurrence monitoring test DetermaMx™. In addition, Oncocyte’s pharmaceutical services provide companies that are developing new cancer treatments a full suite of molecular testing services to support the drug development process.

DetermaRx™, DetermaIO™, DetermaTx™, DetermaCNI™, DetermaMx™ and TheraSure™ are trademarks of Oncocyte Corporation.

Oncocyte Forward Looking Statements

Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to, among other things, the utility and impact of DetermaIO and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on Oncocyte or its subsidiaries’ financial and operational results, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Oncocyte’s third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests Oncocyte or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Investor Contact

Bob Yedid
LifeSci Advisors, LLC
646-597-6989
bob@lifesciadvisors.com

Media Contact

Megan Kernan
ICR Westwicke Healthcare PR
Tel: 646.677.1870
megan.kernan@westwicke.com

FAQ

What is DetermaIO and its significance for bladder cancer treatment?

DetermaIO is a diagnostic test developed by Oncocyte Corporation to predict patient responses to immunotherapy in bladder cancer. Its real-world efficacy has been confirmed in recent studies.

When was DetermaIO launched for clinical use?

DetermaIO was launched for clinical use in the fourth quarter of 2021.

What were the findings of the recent study presented at the AACR Annual Meeting 2022?

The study confirmed DetermaIO's ability to predict responses to immune checkpoint inhibitors in bladder cancer, validating previous clinical trial results.

How does DetermaIO compare to tumor mutational burden (TMB)?

DetermaIO is independent and complementary to TMB, suggesting that a combined model may provide better treatment predictions for patients.

What is the potential impact of DetermaIO on patient outcomes?

DetermaIO could significantly improve treatment decisions and outcomes for patients with bladder cancer by identifying responders to immunotherapy earlier.