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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 (NYSE American: OCX) announced the appointment of Dr. Jennifer Levin Carter to its Board of Directors. Dr. Carter, a leader in precision medicine in oncology, previously served as VP, Head of Precision Health at Integral Health and CEO of N-of-One. Her expertise will be crucial as Oncocyte enhances its molecular diagnostics offerings, including DetermaRx™ and DetermaIO™. These tests aim to improve patient outcomes by identifying suitable cancer treatments and enhancing predictive capabilities in immunotherapy.
Oncocyte Corporation (NYSE American: OCX) will engage in 1-on-1 meetings at the Needham Virtual Cancer Diagnostics 1x1 Conference on August 18, 2020. The company specializes in molecular diagnostics aimed at enhancing cancer care. Their launched test, DetermaRx, identifies early-stage lung cancer patients at high risk for recurrence, optimizing treatment through timely adjuvant chemotherapy. Additionally, they are developing DetermaIO, which assesses patient response to immunotherapies. These innovations aim to improve patient outcomes significantly.
Oncocyte Corporation (NYSE American: OCX) reported significant advancements in its molecular diagnostics, particularly with DetermaRx™. The company secured national Medicare reimbursement starting August 2020, marking a pivotal moment for DetermaRx, which targets non-small cell lung cancer. Additionally, Oncocyte expanded its international distribution, most notably to Israel. For Q2 2020, revenues reached $143,000 with a net loss of $9.1 million, up from $5.4 million year-over-year. The firm expects annualized savings of approximately $3 million due to the discontinuation of DetermaDx™.
Oncocyte Corporation (NYSE American: OCX) will host a webinar on July 30, 2020, featuring lung cancer experts to discuss DetermaRx™, the first predictive test for early-stage lung cancer. Launched in January 2020, DetermaRx has gained Medicare coverage and is now adopted by over 40 hospitals. The test identifies patients at high risk for recurrence, potentially benefiting from adjuvant chemotherapy post-surgery. Esteemed oncologists Dr. David Gandara and Dr. Johannes Kratz will present new data demonstrating the test's clinical utility and impact on disease-free survival.
Oncocyte Corporation (OCX) announced it will release its Q2 financial and operating results for the period ending June 30, 2020, on July 29, 2020, after U.S. market close. The company will host a conference call on the same day at 4:30 PM ET to discuss these results alongside recent developments. Oncocyte specializes in molecular diagnostics with products like DetermaRx™, aimed at assessing early-stage lung cancer patients for recurrence, and DetermaIO™, which identifies patients likely to respond to immunotherapies.
Oncocyte Corporation (NYSE American: OCX) announced that Noridian has issued a final local coverage determination (LCD) for its DetermaRx™ test, establishing Medicare coverage for around 70% of eligible patients with early-stage non-small cell lung cancer (NSCLC). This marks DetermaRx™ as the first and only test in a new class of predictive tests. The estimated addressable market for the test could reach approximately $500 million globally. This development enhances patient access and validates DetermaRx™'s role in improving treatment decisions for lung cancer patients post-surgery.
Oncocyte Corporation (NYSE American: OCX) announced that its clinical validation study for DetermaDx™, a liquid biopsy test for lung nodules, did not meet its performance endpoint. Consequently, the company will cease further investment in DetermaDx and refocus on DetermaRx™ and DetermaIO™, which are currently being commercialized in clinical and biopharma markets. DetermaRx has shown promise in early-stage lung cancer management with significant market potential, while DetermaIO targets immunotherapy response prediction, addressing a need in patient selection for treatment.
Oncocyte Corporation (NYSE American: OCX) has announced significant progress as it begins generating revenue. The company has received its first diagnostic revenue for its test DetermaRx™ from multiple commercial payers and has initiated Medicare claims submissions. DetermaRx™, a predictive test for Stage I-IIA non-squamous NSCLC patients at high risk for recurrence, is now set to improve clinical outcomes and healthcare economics. The company reports consistent month-over-month increases in test volumes, marking a pivotal transition to a commercial stage operation.
Oncocyte Corporation (NYSE American: OCX) announced presentations at the 2020 ASCO, focusing on the DetermaIO™ test and its application in triple-negative breast cancer (TNBC). The results suggest that DetermaIO could identify patients likely to respond to checkpoint inhibitor therapy. Additionally, the DetermaRx™ test presents potential healthcare savings of up to $450 million through improved disease-free survival for lung cancer patients. The company aims to make DetermaRx more accessible following recent Medicare coverage changes.
Oncocyte Corporation (OCX) announced significant advancements in its molecular diagnostics, particularly with DetermaRx™, which may be covered by Medicare for 70% of eligible early-stage NSCLC patients. The company secured international collaboration with CORE Diagnostics for DetermaRx™ distribution in India and the Middle East. Financial results showed a net loss of $7.7 million for Q1 2020, up from $3.9 million in the previous year, largely due to increased operational costs. Cash reserves were at $16.9 million as of March 31, 2020. The company continues to expand its pharma services and aims for broader reimbursement options.
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