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Oncocyte Corporation (OCX) is a pioneering precision diagnostics company dedicated to the discovery, development, and commercialization of non-invasive, liquid biopsy diagnostics aimed at facilitating clinical decision-making in the early detection of cancer. The company focuses on molecular tests that address high unmet needs in the diagnosis of lung, breast, and bladder cancers, conditions where current diagnostic standards are often ambiguous, costly, and invasive. Oncocyte's tests are developed based on a proprietary set of biomarkers, designed to differentiate between benign and malignant nodules or masses.
Oncocyte’s flagship products include:
- DetermaIO™: A gene expression test that assesses the tumor microenvironment to predict response to immunotherapies.
- DetermaCNI™: A blood-based monitoring tool for therapeutic efficacy in cancer patients.
- VitaGraft™: A blood-based solid organ transplantation monitoring test.
- GraftAssure™: A research-use-only monitoring test for solid organ transplantation.
The company has made significant strides in expanding its diagnostic capabilities and achieving key regulatory and commercial milestones. In 2023, Oncocyte secured reimbursement for VitaGraft™ Kidney, manufactured the initial lots of GraftAssure RUO, and entered a strategic partnership with Bio-Rad Laboratories to commercialize GraftAssure and develop VitaGraft Kidney IVD. This partnership, along with a successful $15.8 million private placement offering, positions Oncocyte well to meet its critical commercial and regulatory goals.
Oncocyte continues to be supported by strong core investors and aims to provide clarity and confidence to physicians and their patients through its groundbreaking diagnostic tests. For more information, visit www.oncocyte.com.
Oncocyte Corporation (Nasdaq: OCX) has successfully completed the second phase of a three-step technology transfer under its Exclusive Sublicense Agreement with Burning Rock Biotech. This milestone includes a $2M payment and allows Burning Rock to commercially launch the DetermaRx™ test for early-stage lung cancer in China, where the potential patient population is significantly larger than in the U.S. The third phase, involving software validation and another $1M payment, is expected by April 30, 2022.
Oncocyte Corporation (Nasdaq: OCX) announced a business update call scheduled for December 14, 2021, focusing on its DetermaIO immunotherapy response prediction test and TheraSure Transplant Monitor test. The management team will provide an update on the pipeline and highlight key milestones for major products anticipated in 2022.
DetermaIO is a gene expression test that predicts responses to immuno-oncology therapies, while TheraSure monitors organ transplant health using a blood test, reducing the need for invasive procedures.
Oncocyte Corporation (Nasdaq: OCX) announced new data on its DetermaIO test, which predicts response to immunotherapy in cancers like lung and triple-negative breast cancer. The test will be presented at the 2021 San Antonio Breast Cancer Symposium (SABCS) on December 8 and 9. The DetermaIO test assesses the entire tumor microenvironment to help identify suitable patients for immunotherapy. Oncocyte aims to improve cancer treatment outcomes through precision diagnostics and will provide further results after the market closes on December 9, 2021.
Oncocyte Corporation (OCX) announced the clinical launch of DetermaIO, the first immunotherapy response prediction test that assesses the tumor microenvironment, outperforming PD-L1 IHC. Recent data on Triple Negative Breast Cancer confirms its efficacy. The company reported a 65% year-over-year growth in test volume and raised its transplant monitoring capabilities with new IP. For Q3 2021, revenues reached approximately $1.0 million, a 77% increase from last year, though net losses grew to $13.8 million, or ($0.15) per share.
Oncocyte Corporation (Nasdaq: OCX) has launched the DetermaIO test, the first immunotherapy clinical test that evaluates the tumor microenvironment to predict patient responses to immunotherapy. Clinical studies have shown DetermaIO's accuracy in identifying potential responders, offering significant advantages over existing biomarkers like PD-L1.
The test aims to assist over one million patients annually in the U.S. in selecting effective immunotherapy treatments. Initial interest from physicians is high, and DetermaIO will be integrated with other tests for comprehensive patient management.
Oncocyte Corporation (Nasdaq: OCX) announced the issuance of U.S. Patent No. 11,155,872 for its Therasure Transplant Monitor, enhancing its intellectual property in the $2 billion U.S. transplant market. This blood-based test for organ rejection minimizes the need for invasive biopsies. The company plans to launch a lab-developed test (LDT) by Q1 2022 and aims for FDA submission of a kitted product by H1 2023. The patent fortifies Oncocyte's position in blood-based monitoring, and its technology offers cost-effective monitoring for transplant recipients.
Oncocyte Corporation (Nasdaq: OCX) will announce its third-quarter financial results for the period ended September 30, 2021, on November 9, 2021. A conference call is scheduled for the same day at 4:30 pm ET to discuss the results and corporate developments. Oncocyte focuses on precision diagnostics for cancer, with tests like DetermaRx™ and DetermaIO™ aimed at improving patient outcomes. The company emphasizes its commitment to advancing cancer care through proprietary tests and services, which assist in diagnosis, treatment planning, and monitoring.
Oncocyte Corporation (Nasdaq: OCX) has announced the appointment of Gisela A. Paulsen as the new Chief Operating Officer (COO). With over 20 years of experience in global change management and innovation in diagnostics and pharmaceuticals, Paulsen is expected to drive strategic growth and maximize opportunities within the company. Previously, she served as General Manager at Exact Science’s Precision Oncology and held significant roles at Roche/Genentech. Her appointment is anticipated to enhance Oncocyte's operational capabilities at a critical phase for growth in precision oncology diagnostics.
Oncocyte Corporation (Nasdaq: OCX) has announced peer-reviewed data supporting the effectiveness of its DetermaIO™ test in predicting responses to immunotherapy in high-risk early-stage triple-negative breast cancer (TNBC). Published in the journal Cancers, the study indicates that DetermaIO outperforms the standard PD-L1 IHC biomarker. The test's predictive ability was validated using biopsy samples from 55 patients involved in a neoadjuvant clinical trial. This research highlights DetermaIO's potential to guide treatment decisions early on, enhancing patient outcomes.
Oncocyte Corporation (OCX) announced positive results from the NeoTRIPaPDL1 clinical trial, showcasing DetermaIO as a predictive biomarker for immune therapy response in triple-negative breast cancer (TNBC). The trial enrolled 241 patients across multiple countries, demonstrating a 71% response rate for IO score positive patients receiving both immunotherapy and chemotherapy. This contrasts significantly with a 51% response rate in the chemotherapy-only group. DetermaIO's potential for pan-cancer application and its forthcoming clinical launch in Q4 2021 could tap into a $3 billion US market.
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