COMPANY:

Oncocyte

"Oncocyte Corp...announced the peer-reviewed publication of positive data related to its proprietary gene expression test, DetermaIO™."

P3 | N=278 | NeoTRIPaPDL1 (NCT02620280) | "Oncocyte Corp...announced the peer-reviewed publication of positive data related to its proprietary gene expression test, DetermaIO....As noted above, patients receiving a DetermaIO-positive (IO+) result had a significantly higher pathologic complete response (pCR) rate when treated with atezolizumab plus chemotherapy (69.8%) compared to chemotherapy alone (46.9%). DetermaIO-negative (IO-) result patients did not show improved pCR rates with the addition of atezolizumab compared to chemotherapy alone (44.6% vs 49.2%). The interaction test between DetermaIO and the treatment arm was statistically significant (P-value = 0.043). In an unselected patient population, the addition of atezolizumab achieved a numerically higher pCR rate (48.6%) but did not show a significant improvement over the chemotherapy-only arm (44.4%) in patients with TNBC."

"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."

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."

"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)."

"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."

"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."

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 | 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."

"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..."

"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."

"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."

"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."

"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."

"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."

"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."

"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)."

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.

"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."

"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."