COMPANY:

Oncocyte

"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."

"Oncocyte Corporation (Nasdaq: OCX)...announced the publication of peer-reviewed data showing the strong predictive ability of its 27-gene DetermaIO™ test in predicting immunotherapy (IO) responses in high-risk early-stage triple negative breast cancer (TNBC). The article titled 'A Novel Immunomodulatory 27-Gene Signature to Predict Response to Neoadjuvant Immunochemotherapy for Primary Triple-Negative Breast Cancer', was published in the journal Cancers."

"Oncocyte Corporation (Nasdaq: OCX)...today presented new data in an oral presentation at the European Society for Medical Oncology Congress (ESMO) 2021 evaluating DetermaIO™ as a biomarker for immune therapy response. The results demonstrated in a randomized clinical trial setting that DetermaIO, a 27-gene precision diagnostic, is predictive of response to neoadjuvant immune checkpoint inhibitor treatment of triple negative breast cancer (TNBC), and support the potential of DetermaIO to serve as a precision diagnostic for this important class of novel therapies with expanding indications across tumor types."

"Oncocyte Corporation (Nasdaq: OCX)...announced that it will host a two-part key opinion leader (KOL) event in Transplant Rejection Testing, and DetermaIO™ in triple-negative breast cancer."

"Oncocyte Corporation...announced today that it will present new data from ongoing clinical research evaluating the 27-gene DetermaIO™ assay used to determine the likelihood of response to IO therapies at the upcoming European Society for Medical Oncology (ESMO) Congress, taking place virtually September 16th-21st, 2021."

"Oncocyte Corporation...announced today the launch of a nationwide, prospective, real-world (RW) registry for patients with potentially curable early-stage lung cancer. The study is entitled the Predictive Assay for Decision Making in Adjuvant Therapy (PADMA) Registry...The PADMA Registry, which utilizes Oncocyte’s DetermaRx test, will be the first RW initiative to evaluate the use of biomarkers in early-stage lung cancer."

"Echelon Diagnostics…announced a strategic collaboration with Oncocyte Corporation...The two companies will work together to develop analytical software that can scale to support the commercial expansion of Oncocyte’s tests and solutions that may help diagnosis and treatment of cancer, leading to improved patient outcomes and reducing the overall cost of care."

"Oncocyte Corporation...today announced a strategic collaboration with Gruppo Oncologico del Nord-Ovest (GONO Foundation) of Pisa, Italy to evaluate DetermaIO, Oncocyte's proprietary gene expression test that assesses the tumor immune microenvironment from a biopsy sample, as a biomarker for immunotherapy response in metastatic colorectal cancer (mCRC)....Heinz-Josef Lenz, M.D...said, 'I believe that DetermaIO is going to be an important and clinically useful biomarker in identifying responders to immune-therapy, and the clinical evidence generated so far is very exciting....If DetermaIO can successfully identify additional patients who would respond to IO therapy but are not indicated by the MSI marker, this would become another significant step in supporting its pan-cancer clinical utility."

"Oncocyte Corporation...has signed an agreement with QIAGEN N.V. to support the launch of Amgen’s LUMAKRAS (Sotorasib)...QIAGEN was selected by Amgen to develop a tissue-based companion diagnostic (CDx) for the new therapy with indications in lung cancer, and QIAGEN selected Oncocyte as a “Day One” clinical lab for offering the QIAGEN Therascreen RGQ KRAS CDx test."

"Oncocyte Corporation...will be presenting new data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, held virtually from June 4-8, 2021. The presentation will feature data from a study of Oncocyte’s novel predictor of immunotherapy response, DetermaIO™, demonstrating test performance in renal cell cancer...Presentation Title: Validation of prediction of ICI response of a 27-gene immune and wound response classifier in renal cell cancer."

"Oncocyte Corporation...has completed its acquisition of Chronix Biomedical, a privately held molecular diagnostics company developing blood tests for use in cancer treatment and organ transplants. The acquisition includes the intellectual property and technology for Chronix’s TheraSure™-Copy Number Instability (CNI) Monitor test for immune therapy monitoring."

"Oncocyte Corporation...announced findings from a study using the DetermaIO™ immuno-oncology algorithm to assess patients likely to benefit from immunotherapy across multiple cancer types...The study’s researchers hypothesized that measuring the activity of the tumor microenvironment (TME) may be useful in patient selection for ICI therapy, and developed a novel algorithm that can be applied to gene expression data from a small set of most relevant genes, potentially making the assay practical and cost effective for clinical use...this study shows we were able to apply it to a non-small cell lung cancer cohort. We believe that this algorithm may give DetermaIO independent and incremental predictive value over the current gold standard biomarkers in the clinic."

Investor Presentation: In NCCN guidelines in 2H 2021

"Oncocyte Corporation...will be presenting new data at the American Association for Cancer Research (AACR) Annual Meeting 2021, held virtually from April 10-15, 2021. The presentations will feature data from studies regarding Oncocyte’s novel predictor of immune therapy response, demonstrating the potential for the applicability of its gene expression test across multiple cancers...Presentation Title: Pathway modeling to translate the 27-gene immuno-oncology algorithm into bladder cancer...The dramatic separation of tumors expressing a 'hot', inflammatory signature as opposed to a 'cold' immune repressive signature, supported the application of the TME gene expression signature to the study of immune response therapeutics in bladder cancer without changing either the algorithm or the classification thresholds."

Investor Presentation

"Oncocyte Corporation…has signed an agreement with MultiPlan to participate in its networks. Through this agreement DetermaRx™ will now be available to those consumers with access to the PHCS and MultiPlan Network, MultiPlan’s national primary and complementary networks, at a pre-negotiated price per test."

"Oncocyte Corporation...has closed its previously announced second investment in Razor Genomics ('Razor'), and now owns all of Razor’s outstanding shares. In September 2019 Oncocyte acquired the rights to develop and market Razor’s treatment stratification test, now known as DetermaRx™, Oncocyte’s lead diagnostic test, through certain agreements entered into with Razor. At that time, Oncocyte was granted an option to purchase the outstanding shares of Razor common stock, which Oncocyte agreed to exercise upon the achievement of certain milestones by Razor."

"Oncocyte Corporation...today announced that it has entered into an agreement to acquire, through a subsidiary, Chronix Biomedica...Under the agreement, which supersedes the previous collaboration agreement between the companies announced in October 2020, Oncocyte will acquire the intellectual property (IP) and technology for Chronix’s TheraSure™-CNI Monitor, a patented, blood-based test for immune-therapy monitoring, as well as the IP for Chronix’s organ transplant technology... Further, Chronix’s development and business team will become part of the Oncocyte R&D Team and will maintain lab operations in Germany to support the continued development and commercial launch of the monitoring tests. The EU-based team will also lead Oncocyte’s commercial efforts with DetermaRx™ and DetermaIO™ in Germany and other EU member countries upon closing of the transaction."

"Oncocyte Corporation...today announced that it will present a scientific poster highlighting the broad adoption and real-world clinical utility of its DetermaRx™ test for early-stage lung cancer at the IASLC 2020 World Conference on Lung Cancer (#WCLC20), hosted by the International Association for the Study of Lung Cancer, taking place virtually on January 28-31, 2021. These new findings reinforce previously published data showing the DetermaRx test outperforms standard clinical factors that are used to identify and treat patients at high risk of recurrence following surgery. Previously published studies have shown that these patients have a significant improvement in survival when treated with adjuvant chemotherapy—92% compared with 49%."

"Burning Rock Biotech...today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx™, a risk stratification test for early stage lung cancer patients, to China...test-identified low-risk patients had a 5-year freedom from recurrence (FFR) rate of 94.6%; test-identified high-risk or intermediate-risk patients who were treated with adjuvant platinum chemotherapy had 96.7% 5-year FFR compared to 71.7% 5-year DFS for high-risk patients who did not receive chemotherapy...'This agreement with Burning Rock accelerates the ongoing expansion of our DetermaRx test to patients and physicians outside the U.S., and exemplifies our global growth strategy.'"

"Oncocyte Corporation...today announced that the Company will host a key opinion leader (KOL) call on the Company’s proprietary DetermaRx™ and DetermaIO™ molecular tests for cancer treatment selection on Tuesday, December 15, 2020 at 11:00am Eastern Time…They will also provide an update on the commercialization strategy for both DetermaRx™ and DetermaIO™, two of the Company’s initial growth engines from the Determa Platform approach "

"Oncocyte Corporation…today provided an update on DetermaRx’s global growth and adoption...Key third quarter DetermaRx growth metrics: Testing volume of DetermaRx more than doubled from the second quarter to 175 billable samples. Maintained a re-order rate of ~60%...Expanded international distribution of DetermaRx through an agreement with GenCell, a specialized oncology diagnostics distributor with operations in Mexico, Colombia, and Brazil, effective September 10, 2020." "

"Oncocyte Corporation...today announced that new prospective data on DetermaRx™ will be presented at the IASLC 2020 North America Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer...DetermaRx is a treatment stratification test that identifies stage I-IIA non-small cell lung cancer (NSCLC) patients at high-risk of recurrence despite ostensibly curative surgery, who may benefit from the addition of chemotherapy....'We are very pleased that the initial data showing this test’s impact on cancer recurrence was maintained in the 250-patient expanded data set. This result establishes DetermaRx as the post-surgical treatment standard for patients diagnosed with NSCLC,' said Dr. Edgardo S. Santos, M.D."

"Oncocyte Corporation…announced a strategic collaboration with the Fondazione Michelangelo (FM) in Milan, Italy to evaluate DetermaIO™ as a biomarker for response in the NeoTRIPaPDL1 trial (NCT02620280). The biomarker trial is a prospectively designed, retrospective study of archived study material from the therapeutic trial in triple-negative breast cancer (TNBC), one of the new frontiers for immune therapy treatment."

"Oncocyte Corporation…today announced that it has agreed to enter a licensing and collaboration agreement with Chronix Biomedical. Oncocyte is licensing Chronix’s patented CNI Monitor technology for the TheraSure™-CNI MONITOR clinical assay. This liquid biopsy diagnostic uses copy number instability (CNI) to sensitively quantify the cell-free DNA from the primary solid tumor in a patient’s blood. As part of the collaboration, Chronix will use its proven laboratory network in Germany to accelerate the EU market commercial launch of Oncocyte’s DetermaRx™."

"Oncocyte Corporation...today announced that it has received a pricing decision from Centers for Medicare and Medicaid Services (CMS) for DetermaRx™, the Company’s treatment stratification test that identifies which early stage lung cancer patients are at high risk for lung cancer recurrence post-surgery. This is the first and only testing available for this indication."

"Oncocyte Corporation...and the Guardian Research Network® (GRN)...today announced a strategic collaboration to create a comprehensive solution for pharma clients from patient recruitment to regulatory approvals. Oncocyte and GRN aim to leverage their joint capabilities by bringing together GRN’s clinical trial enrollment and data science technology with Oncocyte’s proprietary molecular tests, including DetermaRx™ for early stage lung cancer and DetermaIO™ for immunotherapy selection, as well as Oncocyte’s pharma and companion diagnostic development services. The collaboration is designed to reduce the time to populate immune targeting trials while also improving chances for successful trials through proprietary molecular patient stratification."