Part 1: Transplant Rejection Testing – Wednesday, September 22
nd
@ 1pmET
Part 2: DetermaIO™ in Triple-Negative Breast Cancer – Tuesday, September 28
th
@ 1pmET
IRVINE, Calif., Sept. 20, 2021 (GLOBE NEWSWIRE) — Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer, today announced that it will host a two-part key opinion leader (KOL) event in Transplant Rejection Testing, and DetermaIO™ in triple-negative breast cancer.
Part 1: Transplant Rejection Testing
Wednesday, September 22
nd
@ 1pmET – 2:30pmET
The KOL Webinar will feature a presentation by Key Opinion Leader (KOL) Michael Oellerich, MD, Hon MD, FAACC, FAMM, FFPath (RCPI), FRCPath (George-August-University Göttingen). Dr. Oellerich will discuss the unmet medical needs and current treatment landscape in transplant rejection testing and Oncocyte’s recent acquisition of proprietary capabilities for immunosuppressive therapy monitoring and transplant rejection testing, both from a standard blood sample. Oncocyte’s technologies may provide more precision to selecting appropriate immune therapies and monitoring for treatment response in real-time, allowing physicians to personalize treatment more effectively.
Dr. Oellerich and Ekkehard Schuetz, MD, PhD, FAACC, and SVP, Therapeutic Monitoring R&D at Oncocyte, will be available to answer questions following the formal presentation. Prior to the acquisition by Oncocyte Dr. Schuetz served as CEO, CSO and CMO of Chronix Biomedical. Dr. Schuetz has over 30 years of experience in laboratory diagnostics focusing on molecular diagnostics in transplantation, and has spent over 20 years conducting cell-free DNA research. Dr. Schuetz has 200 scientific publications as well as numerous patents. Additionally, he is the inventor of digital PCR technology to quantify donor-derived cfDNA for early detection or rejection. Inc.
Part 2: DetermaIO™
Tuesday, September 28
th
@ 1pmET – 2pmET
The KOL Webinar will feature a presentation by Key Opinion Leaders (KOLs) Priyanka Sharma, M.D. (University of Kansas Medical Center) and Giampaolo Bianchini, M.D. (San Raffaele Hospital, Milano, Italy). Dr. Sharma will discuss the unmet need for identifying patients with triple-negative breast cancer (TNBC) who will respond to immunotherapy. Dr. Bianchini will present results from the NeoTRIP randomized clinical trial, selected for an oral podium presentation at the ESMO (European Society of Medical Oncology) conference- which evaluated Oncocyte’s DetermaIO as a predictive biomarker for immunotherapy response prediction in TNBC. DetermaIO is a pan-cancer proprietary gene expression test that assesses the tumor microenvironment. In studies conducted across multiple tumor types (lung, breast, bladder, and kidney cancer) and all approved immunotherapies (Keytruda, Opdivo, Imfinzi, and Tecentriq), the DetermaIO test has consistently identified both responders and non-responders missed by current biomarkers (PD-L1 and TMB), positioning it to fulfill a well-recognized unmet need for optimizing the use of immunotherapy for more than 1 million patients who are eligible for this treatment each year. The test is run in a CLIA/ CAP-accredited laboratory. It is expected to launch clinically as part of an early access program later this year. The DetermaIO test for immunotherapy treatment selection, and the Company’s complementary DetermaCNI test, a proprietary blood-only test for monitoring response to treatment, are designed to enable oncologists to manage patients longitudinally during the course of their cancer treatment.
To register and attend the events, please click below. You are required to register for each webcast separately.
Part 1: Transplant Rejection Testing – Wednesday, September 22
nd
Part 2: DetermaIO™ in Triple-Negative Breast Cancer – Tuesday, September 28
th
Dr. Oellerich is a chemical pathologist and currently a Distinguished Research Professor at the Department of Clinical Pharmacology, University Medical Center (UMG) of the George-August-University Göttingen, Germany. From 2012 to 2017, he had an appointment as a Lower Saxony Distinguished Professor. He was chairman of the Department of Clinical Chemistry/Central Laboratory at UMG from 1991 to 2012. He received Fellowships of the Royal College of Pathologists (FRCPath) in 2006, of the Faculty of Pathology of the Royal College of Physicians of Ireland [FFPath (RCPI)] in 2006, of the AACC Academy (FAACC) of the American Association for Clinical Chemistry in 2012, and the Academy of Medicine of Malaysia (FAMM) in 2014. Since 2013, he has been a member of the Transplantation Advisory Board of Chronix Biomedical Inc Irvine, a fully owned subsidiary of Oncocyte.
From 1996 to 1998, he served as Dean of the Faculty of Medicine and as the Deputy of the Chief Executive for Research and Teaching on the executive board for the Medical Center and Faculty of Medicine (1999-2004). He was President of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) (1997-1999), of the German Association for Laboratory Medicine (2001-2002), and the German United Association for Clinical Chemistry and Laboratory Medicine (2003-2005). Subsequently, he was Secretary-Treasurer of the World Association of Societies of Pathology and Laboratory Medicine (WASPaLM) (2005–2007), President (2009–2011), immediate past-President (2011–2013), and Director Europe (2013-2017). Since 2016, he has been Executive Secretary of the International Society of Enzymology and, since 2017, Chief Research Officer of the Liquid Biopsy Center GmbH (LBC), Göttingen, Germany. From 1999 to 2010, he was a member of the Steering Committee of EUROLIFE, a network of European Centers of Excellence in life sciences. He served as External Examiner for the Second Professional Examination 2009/2010 of the Faculty of Medicine at the Chinese University of Hong Kong. He is an honorary member of the Romanian Society of Laboratory Medicine (Sibiu 2007), the Bulgarian Academy of Sciences and Arts (BASA) (Sofia 2012), and of IATDMCT (Salt Lake City, USA, 2013). He was Editor-in-Chief of the journal Therapeutic Drug Monitoring (2003-2018) and currently is Associate Editor of this journal. He was Associate Editor of Clinical Biochemistry (1996–2007), Associate Editor of Clinical Chemistry (2007-2013), and Guest Editor (Special Issues) of Clin Chim Acta 2012 and J Appl Lab Med 2020. He was on the Editorial Board of Clinical Chemistry (2002-2007; 2014-2016) and is currently on the Editorial Boards of Clinical Biochemistry and J Mol Clin Pathol, Folia Med, Turk J Pediatr Biochem, and Indian J Clin Biochem. He is a member of the Advisory Boards of Ital J Lab Med and Braz J Pathol Lab Med.
His current research interests are in the field of therapeutic drug monitoring, with a particular focus on endogenous biomarkers to achieve personalized immunosuppression in transplantation (e.g., donor-derived cell-free DNA), as well as ctDNA as a “liquid biopsy” in cancer. Further topics include proteomics and analytical techniques (e.g., LC-MS/MS). He has authored more than 470 publications (articles contributed to scientific journals, book chapters, books edited). He received the following awards: Ludolf-Krehl prize of the S.W. German Society for Internal Medicine in 1971, the IATDMCT Award, Cairns (Australia) 1999, the IATDMCT Charles Pippenger Award for Outstanding Contributions to Therapeutic Drug Monitoring, Washington (USA) 2001, the 2002 Canadian Society of Clinical Chemists Travelling Lectureship Award, the Professor-Landbeck-Award of the Society for Thrombosis and Hemostasis Research, Hamburg (Germany) 2004, the Perth PathCentre Visiting Lectureship, Western Australia 2004, the WASPaLM Medal of Honor, Las Vegas (USA) 2011, the WASPaLM Gold Headed Cane, Quebec City (Canada) 2013, and the Sign of Honor, Professor Jordan Todoroff, of the BSCL, Sofia (Bulgaria) 2019.
Priyanka Sharma, MD, is a Professor of Medicine at the University of Kansas Medical Center and assistant director of clinical research and co-program leader for the Drug Discovery, Delivery & Experimental Therapeutics program at the University of Kansas Cancer Center. She is the principal institutional investigator (PI) for South West Oncology Group (SWOG) and co-PI for The University of Kansas Cancer Center – Masonic Cancer Alliance NCORP (NCI Community Oncology Research Program Minority/Underserved UG1).
Dr. Sharma received her medical degree from MS University of Baroda, India. She completed internal medicine residency, chief residency, and Hematology-Oncology fellowship at the University of Kansas Medical Center. Her research interests include clinical and translational research in triple-negative breast cancer (TNBC) and the assessment of novel therapeutic strategies for breast cancer. She led several investigator-initiated trials assessing novel therapeutic agents for breast cancer and serves as principal investigator for many ongoing breast cancer trials. Dr. Sharma is the recipient of several grants, including the American Society of Clinical Oncology (ASCO) Advanced Clinical Research Award, Mary-Kay Foundation grant, and SWOG ITSC grant.
Dr. Sharma is Vice-Chair of the SWOG Breast Committee, a member of the SWOG Board of Governors, and a member of the NCI breast cancer steering committee.
Dr. Bianchini is the Head of the Breast Cancer Group in the Department of Medical Oncology. He is also the Head of the clinical translational and immunotherapy research group and assistant professor for the integrated oncology course at the Università Vita-Salute San Raffaele in Milan. He has been trained as a breast cancer specialist at the Breast Cancer Division of the Istituto Nazionale dei Tumori in Milan. He has been a visiting scientist at different US institutions, such as the National Cancer Institute, the MD Anderson Cancer Center, and Yale Cancer Center. He has more than 20 years of clinical experience following breast cancer patients. He has been involved as principal investigator and co-investigator in more than 100 clinical trials during his career. He has published articles focused on breast cancer in several international journals, including Lancet Oncology, Cancer Cell, Journal of Clinical Oncology, JNCI, Nature Review Clinical Oncology, JAMA Oncology, Annals of Oncology, and Cancer Research. He has more than 200 invited lectures and over 70 presentations at international meetings. Other areas of interest and expertise include translational studies and bioinformatic analysis to define prognostic and predictive biomarkers for breast cancer and response to immunotherapy. He is the co-inventor of a patent to describe which patients benefit from the pertuzumab/trastuzumab combination. He is engaged in several studies to exploit immune system’s role in cancer and the potential of immunotherapies to treat breast cancer patients and other solid tumors.
About Oncocyte Corporation
Oncocyte is a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer. The Company, through its proprietary tests and pharmaceutical services business, aims to help save lives by accelerating the diagnosis of cancer and advancing cancer care. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients at every stage. DetermaRx™ identifies early-stage lung cancer patients who are at high risk for cancer recurrence and who may benefit from adjuvant chemotherapy. DetermaIO™, a gene expression test currently used as a research-use only tool, assesses the tumor microenvironment to predict response to immunotherapies. The Company’s pipeline of tests in development also includes DetermaTx™, which will assess mutational status of a tumor, blood-based monitoring test DetermaCNI™, and long-term recurrence monitoring test DetermaMx™. In addition, Oncocyte’s pharmaceutical services provide companies that are developing new cancer treatments a full suite of molecular testing services to support the drug development process.
DetermaRx™, DetermaIO™, DetermaTx™, DetermaCNI™ and DetermaMx™ are trademarks of Oncocyte Corporation.
Oncocyte Forward Looking Statements.
Oncocyte cautions you that this press release contains forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to the DetermaIO and DetermaCNI tests, including the potential of DetermaIO to fulfill the unmet need for optimizing the use of immunotherapy for more than 1 million patients who are eligible for this treatment each year, the expectation that DetermaIO will launch clinically as part of an early access program later this year and the potential of DetermaIO and DetermaCNI to enable oncologists to manage patients longitudinally during the course of their cancer treatment. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on Oncocyte or its subsidiaries’ financial and operational results, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Oncocyte’s third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests Oncocyte or its subsidiaries commercialize, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Investor Contact
Bob Yedid
LifeSci Advisors, LLC
646-597-6989
[email protected]
