Welcome to our dedicated page for Oncocyte Corporation news (Ticker: OCX), a resource for investors and traders seeking the latest updates and insights on Oncocyte Corporation stock.
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 partnered with Gruppo Oncologico del Nord-Ovest (GONO Foundation) to evaluate the DetermaIO test for predicting immunotherapy response in metastatic colorectal cancer (mCRC). This marks the test's assessment in a fifth tumor type, following its previous successes in lung, breast, bladder, and renal cancers. The collaboration aims to identify mCRC patients who may benefit from immunotherapy despite lacking the microsatellite instability biomarker. The GONO Foundation conducts clinical trials in oncology, making it a suitable partner for this initiative.
Oncocyte Corporation (NASDAQ: OCX) has announced the addition of the Therascreen RGQ KRAS test in its Nashville CLIA lab, enhancing its diagnostic offerings for lung cancer. This follows a partnership with QIAGEN to support Amgen’s LUMAKRAS therapy for KRAS G12C-mutated Non-Small Cell Lung Cancer (NSCLC). As a result, Oncocyte aims to consolidate its position as a key player in cancer diagnostics, providing essential information for treatment decisions. The new test addresses an unmet clinical need, as KRAS G12C mutations represent 25% of all NSCLC cases.
Oncocyte Corporation (NASDAQ: OCX) reported Q1 2021 revenues of $1.12 million, exceeding analyst estimates, driven by growth in DetermaRx and Pharma Services. The company highlighted strong data supporting the pan-cancer utility of DetermaIO, with pilot projects secured from three biopharma partners. The acquisition of Chronix Biomedical opens opportunities in the blood-based therapy monitoring market. Operating losses increased to $11.4 million, while cash used in operations was approximately $9.8 million. The anticipated launch of DetermaIO and other products may drive significant revenue growth in the next 18-24 months.
Oncocyte Corporation (Nasdaq: OCX) announced a pathway for Medicare reimbursement coverage for its TheraSure™ Transplant Monitor test, aimed at monitoring organ transplant rejection. The decision by Palmetto, a CMS contractor, simplifies the reimbursement process for molecular testing using donor-derived cell-free DNA (dd-cfDNA). The pricing for the test is set between $2,700 to $2,800, with potential total revenues estimated at $40,000 to $50,000 per patient over two to three years. The company views this as a significant asset in the $3.5 billion global transplant rejection diagnostic market.
Oncocyte Corporation (Nasdaq: OCX) announced it will share its financial and operating results for Q1 2021 on May 17, 2021, after market closing. A conference call will be held the same day at 4:30 PM ET. The company focuses on molecular diagnostics to aid cancer care, particularly through tests like DetermaRx and DetermaIO. Oncocyte has plans to launch DetermaTx in the latter half of 2021 and recently acquired Chronix Biomedical and its TheraSure™ test.
Oncocyte Corporation (Nasdaq: OCX) announced new findings for its immunotherapy response predictor, DetermaIO, showing effectiveness across four tissue types, indicating potential for broader cancer applicability. This data, which highlights the test's performance in renal cell carcinoma, will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8, 2021. The study suggests DetermaIO's capacity to identify likely immunotherapy responders, paving the way for its use in various solid tumors.
Oncocyte Corporation (NASDAQ: OCX) has acquired Chronix Biomedical, enhancing its capabilities in immune therapy monitoring and transplant rejection testing. The acquisition includes the TheraSure™-Copy Number Instability (CNI) Monitor test, allowing for faster monitoring via standard blood samples, bypassing the need for tissue samples. This positions Oncocyte to launch its full suite of tests in Europe and penetrate an estimated $3 billion U.S. market for blood-based immune therapy monitoring. The deal involves $4.25 million in cash, $3 million in stock, and potential future payments up to $14 million based on milestones.
Oncocyte Corporation (Nasdaq: OCX) will host a key opinion leader (KOL) call on April 19, 2021, focusing on novel biomarkers for immune checkpoint inhibitor responders. The event features experts from UC Davis discussing the efficacy and limitations of current biomarkers, including PD-L1 and tumor mutational burden (TMB). New data on DetermaIO™, a 27-gene test, will highlight its strong performance in identifying bladder cancer patients suitable for atezolizumab treatment. This expands the potential pan-cancer application of DetermaIO™ beyond its previous data in non-small cell lung cancer and triple-negative breast cancer.
Oncocyte Corporation (Nasdaq: OCX) presented promising data at the AACR Annual Meeting 2021 regarding its DetermaIO test, showcasing a significant correlation with two-year overall survival rates in metastatic bladder cancer patients treated with atezolizumab. The test identified immunotherapy-responsive patients that were overlooked by existing biomarkers. With potential applications across various solid tumors, DetermaIO is poised to enter the $3 billion U.S. immuno-oncology diagnostic market. A webinar on these findings is scheduled for April 19, 2021.
Oncocyte Corporation (Nasdaq: OCX) announced its participation in the 20th Annual Needham Virtual Healthcare Conference on April 14, 2021, at 10:15 am EDT. The event will feature a fireside chat where management will discuss the company's advancements in molecular diagnostics aimed at improving cancer care. A live webcast of the presentation will be accessible via their website, and a replay will be available afterward. Oncocyte is focused on developing proprietary tests like DetermaRx and DetermaIO to enhance cancer diagnosis and treatment.
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