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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 Corp (Nasdaq: OCX), a diagnostics technology company, has announced its participation in 'J.P. Morgan Week' alongside the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco from January 13-16, 2025.
CEO Josh Riggs and CFO Andrea James will be available for one-on-one meetings with investors during the event. Interested investors can schedule meetings through Julie Silber at PCG Advisory.
Oncocyte Corp. (OCX) announced favorable data for its DetermaCNI™ assay in diagnosing brain tumors through liquid biopsy. Published in Acta Neuropathologica Communications, the study showed the assay's ability to measure somatic copy number aberrations (SCNAs) in cerebrospinal fluid for diagnosing central nervous system tumors.
The study detected SCNAs in 10 out of 12 patients with confirmed central nervous system cancers, while showing no SCNAs in 11 patients with benign lesions. This technology could benefit nearly 300,000 U.S. patients annually who face primary brain tumors or brain metastasis, representing a potential $300 million U.S. market opportunity. The method could provide a less invasive alternative to current brain tissue biopsies.
Oncocyte announced favorable data for its VitaGraft Kidney diagnostic assay, published in Nephrology Dialysis Transplantation. The study demonstrates the test can detect antibody-mediated rejection (AMR) in kidney transplant recipients approximately 11 months earlier than standard protocols. Using donor-derived cell-free DNA (dd-cfDNA) testing, VitaGraft diagnosed AMR in a median of 2.8 months compared to 14.5 months with standard care in patients with donor-specific antibodies. This marks the first randomized interventional study validating dd-cfDNA as a rule-in test for biopsy in high-risk populations.
Oncocyte (OCX) reports progress in commercializing its transplant rejection testing technology. The company has signed agreements with leading transplant centers in the U.S., Germany, Switzerland, Austria, and the U.K. Their customers now represent about 9% of German transplant volumes and 2% of U.S. transplant volumes. The company is on track to sign 20 transplant centers by end of 2025, with each center potentially generating annual revenue of several hundred thousand to $2 million. The FDA pre-submission process for their kitted clinical test is underway, with a meeting scheduled for December. The company recently raised $10.2 million through a private placement at market price of $2.948 per share.
Oncocyte Corp (Nasdaq: OCX) has announced it will release its third quarter 2024 financial results on Tuesday, November 12, 2024, after U.S. market closes. The company will host a conference call and webcast at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time on the same day. Investors can access the call via toll-free number 800-715-9871 for domestic callers or +1 (646) 307-1963 for international callers, using Conference ID 4153469. A webcast replay will be available on the company's website after the call.
Oncocyte Corp (NASDAQ: OCX), a diagnostics technology company, announced its participation in the 17th annual LD Micro Main Event in Los Angeles. CEO Josh Riggs is scheduled to present on Tuesday, October 29th at 2:30 PM PT at The Luxe Sunset Boulevard Hotel. The company's management will also be available for one-on-one meetings with investors.
The LD Micro Main Event XVII will run from October 28th to 30th, featuring approximately 150 companies presenting in half-hour increments and attending private meetings with investors. Registration begins on October 28th at 3:00 PM PT, followed by keynotes and a happy hour. Presentations will run from 8:00 AM to 5:00 PM PT on October 29th and 30th.
Oncocyte Corp. (Nasdaq: OCX) has announced positive data for its DetermaIO™ gene expression test in a peer-reviewed publication. The NeoTRIP Phase 2 clinical trial assessed DetermaIO's ability to predict which triple-negative breast cancer (TNBC) patients would benefit from adding atezolizumab (immunotherapy) to chemotherapy.
Key findings include:
- DetermaIO-positive patients showed a significantly higher pathologic complete response (pCR) rate with atezolizumab plus chemotherapy (69.8%) compared to chemotherapy alone (46.9%).
- DetermaIO was the only biomarker among those tested that significantly predicted pCR benefit from adding atezolizumab.
- Results were further validated using data from the I-SPY2 Trial with pembrolizumab.
Oncocyte aims to commercialize DetermaIO within 18 months, targeting a multi-billion-dollar oncology diagnostics market.
Oncocyte (Nasdaq: OCX) has announced new agreements with two leading transplant university hospitals in the U.S. and Germany to utilize GraftAssure™, the company's research-use-only assay for detecting early evidence of graft organ damage. This development is part of Oncocyte's strategy to drive commercial adoption of its molecular diagnostic tests in the estimated $1 billion transplant addressable market.
The company has also submitted its plan for an in-vitro diagnostic (IVD) version of its dd-cfDNA kitted test to the FDA, initiating the Q-submission process. A meeting with the FDA is scheduled for early December. Oncocyte aims to begin the validation process in early 2025.
Since August 2024, additional transplant centers have committed to adopting GraftAssure. Oncocyte partnered with Bio-Rad Laboratories in April 2024 for global launch support, with Bio-Rad having exclusive distribution rights outside the U.S. and Germany.
Oncocyte (Nasdaq: OCX) has announced a $10.2 million private placement of securities priced at-the-market under Nasdaq rules. The company has secured participation from new and existing investors, including strategic partner Bio-Rad Laboratories. The private placement involves the sale of 3,461,138 shares of common stock at $2.948 per share, with certain insiders subscribing for 37,037 shares at $2.970 per share.
The net proceeds will be used for working capital and general corporate purposes. The placement is expected to close on or about October 4, 2024, subject to customary closing conditions. Oncocyte's CEO, Josh Riggs, stated that this funding will help expand access to organ transplant rejection testing globally. The company has also entered into a registration rights agreement to file a registration statement with the SEC within 15 days.
Oncocyte Corp. (Nasdaq: OCX) announced the publication of a case series study using its VitaGraft™ Kidney diagnostic test to monitor antibody-mediated rejection (AMR) in kidney transplant patients treated with daratumumab. The study showcases the test's potential to monitor anti-CD38 therapy efficacy. VitaGraft Kidney, a noninvasive biomarker, measures donor kidney DNA in patient blood post-transplantation.
Key findings include:
- Two patients with biopsy-confirmed chronic active AMR showed stabilized kidney function and decreased dd-cfDNA levels after daratumumab treatment
- Biopsies revealed complete or partial resolution of AMR activity
- This is the second study demonstrating VitaGraft Kidney's ability to monitor therapeutic efficacy
Oncocyte aims to improve graft longevity by enabling AMR detection, management, and monitoring. The company is commercializing its transplant product line, including VitaGraft™ and GraftAssure™ tests.
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