^
Contact us  to learn more about
our Premium Content:  News alerts, weekly reports and conference planners

COMPANY:
Oncocyte

i
Other names: Oncocyte | OncoCyte Corporation | Insight Genetics, Inc. | Chronix Biomedical
Related tests:
Evidence

News

1year
Oncocyte presents new data at AACR (Oncocyte Press Release)
"Oncocyte Corporation...announced that five posters of original research are being presented at the Annual Meeting of the American Association for Cancer Research. Four abstracts explore the tumor microenvironment and its potential implications for therapeutic response, leveraging expertise and technology behind DetermaIO. A fifth poster highlights exciting study results applying DetermaCNI, Oncocyte’s proprietary therapeutic monitoring blood test, to metastatic pancreatic cancer."
Clinical data
|
DetermaIO™ • DetermaCNI™
1year
Oncocyte Announces Publication of DetermaIO Results from AtezoTRIBE Study in Metastatic Colorectal Cancer (GlobeNewswire)
P2 | N=201 | AtezoTRIBE (NCT03721653) | "Oncocyte Corporation...announces the peer-reviewed publication of the results of a study applying DetermaIO™ to samples collected from the randomized Phase II AtezoTRIBE clinical trial in metastatic colorectal cancer (mCRC)....In the overall population (n=122), DetermaIO positive patients achieved better outcomes in terms of progression-free survival from the addition of atezolizumab among mCRC patients than DetermaIO negative patients, regardless of MMR status. A similar trend was observed in the pMMR population (n=110) that does not currently qualify for ICI therapy in mCRC."
P2 data
|
DetermaIO™
|
Tecentriq (atezolizumab)
over1year
DetermaIO Clinical Test to be used in SWOG Cancer Research Network Biomarker Study for Breast Cancer (GlobeNewswire)
"Oncocyte Corporation...announced that DetermaIO has been selected by the SWOG Cancer Research Network, an independent global cancer research community that designs and conducts publicly funded clinical trials, to be used in a prospectively designed biomarker study of breast cancer tissues. These tissues were collected during the S1418 Phase III randomized clinical trial of Keytruda® (pembrolizumab) in primary triple negative breast cancer (TNBC)."
Trial status
|
DetermaIO™
|
Keytruda (pembrolizumab)
almost2years
Oncocyte Announces Unanimous Recommendation from the Advisory Panel for Clinical Diagnostic Laboratory Tests on DetermaRx to CMS (GlobeNewswire)
"Oncocyte Corporation...announced that the Advisory Panel for clinical diagnostic laboratory tests (CDLT) has unanimously recommended that starting January 2023, the Company’s DetermaRx™ test be cross-walked to CPT code 81522, currently priced at $3,873. Medicare (CMS) will consider this recommendation and is expected to post its preliminary decision in mid-September for public comments and issue a final determination in mid-November....Separately, the Company announced that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed the validity of a Local Coverage Determination (LCD) reconsideration request for broader coverage for DetermaRx to include risk-stratification (in conjunction with TNM staging) to assess the risk of recurrence for the early-stage NSCLC patient to determine the best course of action for patient management."
Reimbursement
|
DetermaRx™
almost2years
Oncocyte announces five-year VA contract for DetermaRX (Oncocyte Press Release)
"Oncocyte Corporation...announced that the US Department of Veterans Affairs ('VA'), the largest integrated health care system in the United States, has awarded a Federal Supply Schedule Contract for the Company’s DetermaRx™ test."
Licensing / partnership • Commercial
|
DetermaRx™
almost2years
Oncocyte Announces Publication of the Validation of DetermaIO in Predicting Immune Therapy Response in Metastatic Bladder Cancer (GlobeNewswire)
P2 | N=119 | IMvigor210 (NCT02951767) | Sponsor: Hoffmann-La Roche | P2 | N=310 | IMvigor210 (NCT02108652) | Sponsor: Hoffmann-La Roche | "Oncocyte Corporation...announces the peer-reviewed publication evaluating the performance of DetermaIO™ in metastatic urothelial (bladder) cancer treated with the immune checkpoint inhibitor (ICI), Tencentriq® (atezolizumab)....The results of the newly published biomarker study showed that DetermaIO identified 40% of the 348 patients available for DetermaIO biomarker analysis as likely responders, and that they had a median survival of 15.6 months compared to 8.8 months without biomarker stratification. At two years, 41.5% of DetermaIO-positive patients were alive versus 28.6% in the population as a whole....Highlights of the peer-reviewed publication include...DetermaIO outperformed nineteen other genomic signatures and additional existing biomarkers originally selected for testing."
P2 data
|
DetermaIO™
|
Tecentriq (atezolizumab)
almost2years
Oncocyte Presents DetermaIO Data in Podium Presentation at ESMO World Congress on Gastrointestinal Cancer 2022 (Oncocyte Press Release)
P2 | N=201 | AtezoTRIBE (NCT03721653) | "The ESMO GI oral presentation, titled An immune-related gene expression profile predicts the efficacy of adding atezolizumab to first-line FOLFOXIRI/bevacizumab in metastatic colorectal cancer: a translational analysis of the phase II randomized AtezoTRIBE study, highlights how researchers found that within the unstratified cohort of patients from AtezoTRIBE, IOOPT+ tumors more frequently had a high amount of tumor mutational burden and longer PFS. When stratifying by treatment arm, IOOPT+ tumors saw significantly higher PFS for patients who received chemotherapy plus immunotherapy versus those who received chemotherapy alone."
P2 data
|
DetermaIO™
|
Avastin (bevacizumab) • Tecentriq (atezolizumab)
almost2years
Oncocyte hosting key opinion webinar on the role of DetermaIO and the tumor microenvironment in clinical practice (Oncocyte Press Release)
"Oncocyte Corporation...announced that it will host a key opinion leader (KOL) webinar on the role of DetermalO™ and the tumor microenvironment in clinical practice..."
Live event
|
DetermaIO™
2years
Oncocyte presents DetermaIO™ data at ASCO 2022 supporting the test’s potential to expand the clinical use of immunotherapy (Oncocyte Press Release)
"Oncocyte Corporation...announced today new data from ongoing clinical research evaluating the utility of DetermaIO™, the Company’s proprietary test designed to determine the likelihood of benefit of immune checkpoint inhibitors (ICIs), at the upcoming American Society of Clinical Oncology Annual Meeting (ASCO), taking place June 3-7, 2022 virtually and in-person in Chicago."
P2 data
|
DetermaIO™
2years
Oncocyte to present new data at ASCO 2022 underpinning pan-cancer clinical utility of DetermaIO™ (Oncocyte Press Release)
"Oncocyte Corporation...announced today that it plans to present new data from ongoing clinical research evaluating the utility of DetermaIO™ at the upcoming American Society of Clinical Oncology Annual Meeting (ASCO), taking place June 3-7, 2022 virtually and in-person in Chicago."
Clinical data
|
DetermaIO™
2years
Oncocyte presents confirmatory data for DetermaIO™ at the American Association for Cancer Research Annual Meeting 2022 (Oncocyte Press Release)
"Oncocyte Corporation...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."
Clinical data
|
DetermaIO™
2years
Oncocyte to Present New Data Confirming Association of IO Score with Response to Immunotherapy Treatment for Bladder Cancer at the American Association for Cancer Research Annual Meeting 2022 (Oncocyte Press Release)
"Oncocyte Corporation...announced that it will present new confirmatory data on DetermaIO™, its 27-gene expression test used to identify responders to immune checkpoint inhibitor (ICI) therapies, at the American Association for Cancer Research (AACR) Annual Meeting 2022, taking place April 8-13, 2022 in New Orleans."
Clinical data
|
DetermaIO™
over2years
Oncocyte announces development and co-marketing agreement with Thermo Fisher Scientific to expand access to precision oncology (Oncocyte Press Release)
"Oncocyte Corporation...announced a development and co-marketing agreement for two distributed in vitro diagnostic (IVD) assays on Thermo Fisher Scientific’s Ion Torrent™ Genexus™ System...Under the terms of the collaboration, Oncocyte will clinically validate Thermo Fisher’s existing Oncomine Comprehensive Assay Plus* on the Genexus System, paving the way toward IVD clearance for use in tumor profiling and future submissions as a companion diagnostic...Oncocyte will also develop its 27-gene expression DetermaIO™ test as a distributed kit on the Genexus."
Licensing / partnership
|
Oncomine™ Comprehensive Assay v3M • DetermaIO™ • Oncomine™ Comprehensive Assay Plus
over2years
Oncocyte announces peer-reviewed publication in cancers showing utility of DetermaCNI™ blood-only monitoring test to detect recurrence following surgery in epithelial ovarian cancer (Oncocyte Press Release)
"Oncocyte Corporation...announced the publication of data showcasing the clinical utility of its DetermaCNI™ blood-based monitoring test in the peer-reviewed journal Cancers...Results in this peer-reviewed publication demonstrated that DetermaCNI has the potential to address a significant unmet need for patients with primary epithelial ovarian cancer, which is the leading cause of death in gynecological cancers in Western countries."
Clinical data
|
DetermaCNI™
over2years
Spotlight poster presentation at San Antonio Breast Cancer Symposium SABCS 2021 shows Oncocyte’s DetermaIO clinical test predicts response to immunotherapy in triple negative breast cancer (Oncocyte Press Release)
"Oncocyte...announced results showing the ability of the Company’s DetermaIO™ test, a commercially-available precision diagnostic designed to determine the likelihood of response to immunotherapies (IO), at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021)."
Clinical data
|
DetermaIO™
over2years
Oncocyte and Burning Rock complete technology transfer part two and prepare for scaled distribution of DetermaRX in China (Oncocyte Press Release)
Oncocyte Corporation...announced the completion of the second part of the technology transfer under its revised Exclusive Sublicense Agreement with Burning Rock Biotech Limited...Per the agreement, Burning Rock has licensed Oncocyte’s proprietary risk stratification DetermaRx™ test in China, and is now poised to launch the test to the world’s largest early-stage lung cancer market.
Launch
|
DetermaRx™
over2years
Oncocyte to present new data on DetermaIO clinical test for immunotherapy response in triple negative breast cancer at San Antonio Breast Cancer Symposium 2021 (Oncocyte Press Release)
"Oncocyte Corporation...announced that it will present new data from ongoing clinical research evaluating the 27-gene DetermaIO™ test at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021), taking place December 7-10, 2021."
Clinical data
|
DetermaIO™
over2years
Oncocyte announces the clinical launch of DetermaIO immunotherapy response prediction test (Oncocyte Press Release)
"Oncocyte Corporation...today announced the clinical launch of its DetermaIO test. DetermaIO is a proprietary gene expression test that assesses the tumor immune microenvironment (TIME) to predict response to immunotherapy. In multiple clinical studies evaluating hundreds of patients across multiple tumor types, including lung, breast, bladder and renal cancers, the test has demonstrated the ability to predict response to immune checkpoint inhibitors (ICI) which has the potential to help inform the optimal use of immunotherapy treatment for more than one million eligible patients annually in the United States alone."
Launch
|
DetermaIO™