Oncocyte™ is a molecular diagnostics company providing actionable answers at critical decision points across the lung cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment.
President and CEO
Ronnie has over 35 years of experience in the Global Clinical and Molecular Diagnostics industry. He currently serves as the President and CEO of Oncocyte Inc. In his early years in diagnostics, he worked for Abbott Diagnostics in sales and marketing, Immucor as VP of Marketing and Product Development, and the SVP Operations for Roche Molecular Diagnostics.
In his most recent roles, he co-founded and served as Chief Executive Officer of Clarient, a public Molecular Pathology Lab which was sold to General Electric Healthcare in December 2010. After which, he became the President of the Medical Sciences Venture for Life Technologies, and post-acquisition by Thermo Fisher Scientific, he stepped into the President of the Genetic Science Division for Thermo. He is a passionate ambassador for democratization of molecular diagnostic testing into community-based environments to better manage deadly diseases like cancer.
Chief Financial Officer
Mitch joined Oncocyte Corp as Chief Financial Officer in November of 2017 and is responsible for all aspects of financial management and corporate reporting, and is one the most experienced executives globally in capital markets.
From 2000 to 2017, Mr. Levine was Founder of Enable Capital Management, an investment company that grew into one of the largest and most respected brands in alternative finance. Its flagship fund, Enable Growth Partners, provided growth capital to private and publicly traded companies, catalyzing transformative corporate innovation, job growth, and economic expansion in technology, life sciences, consumer products, and energy.
Prior to founding Enable, Mr. Levine was a founding member of The Shemano Group, a leading San Francisco-based investment bank that focused on the capital needs of technology and life science companies. He has also worked at Bear Stearns and Lehman Brothers.
Mr. Levine received his BA from the University of California, Davis.
Chief Operating Officer
Gisela was appointed Chief Operating Officer of Oncocyte Corporation in October 2021, and brings with her over two decades of experience as a cross-functional leader, with an extensive scientific and operational background leading large-scale global change management and driving commercial and drug development innovation at global pharmaceutical and diagnostics companies.
Gisela is a global life sciences general manager with P&L experience who combines a science background with strategy, commercialization, and clinical development experience to build, transform, and grow resilient businesses from start ups to large companies including leading diagnostics company Exact Sciences and global Fortune 500 leader Roche/Genentech. Gisela was named the 100 Most Inspiring People in the Life-Sciences Industry by PharmaVOICE in 2019.
She leads large-scale global change management to drive commercial and drug development innovation. Gisela achieves agile portfolio management by leading strategic vision and scaling for growth to create sustainable, long-term value for shareholders and other stakeholders. She is known for leading solutions to complex organizational and market challenges on aggressive timelines, and the ability to communicate difficult strategies to a diverse audience.
As General Manager of the new business unit for $1B+ cancer screening and diagnostic test leader Exact Sciences (Nasdaq: EXAS), Gisela led newly acquired Genomic Health (Nasdaq: GDHX), renamed Precision Oncology. She drove growth of the existing OncotypeDX© franchise and relaunched therapy selection assay, OncotypeMAP™ Pan-Cancer Tissue, as well as business development and pipeline strategy for future assays and technologies in next generation sequencing, liquid, and Minimal Residual Disease. Gisela managed the integration of Genomic Health and Paradigm, acquired by Exact Science in 2019 and 2020, respectively, and led ~1,000 people supporting the business unit, with a P&L of ~$500 million.
As Senior Vice President & Global Head of Product Development and Clinical Operations for $57 billion-revenue Roche/Genentech, Gisela led a 3,000-member global clinical operations team charged with planning and conducting over 400 late-stage and post-approval evidence generation clinical trials in 60+ countries and nearly 100,000 patients enrolled. Throughout her 15 years with Genentech and Genentech/Roche, Gisela held a variety of executive leadership roles including establishing a cross-functional oncology integration team during Roche’ Genentech acquisition. As Vice President, Access Solutions she led a patient services hub to support patient access to health-critical therapies, driving effectiveness and efficiencies and achieving 50% volume growth of cases with 20% cost reduction while remaining #1
across all therapeutic areas. Through finance and business partnering, she enabled a robust portfolio of molecules for Roche/Genentech in Oncology, Immunology, Infectious Disease, Ophthalmology and Central Nervous System that drove financial trade-offs, investment strategies and valuation, effective portfolio management and innovation.
Gisela holds a Master of Science in Pharmaceutics and Drug Delivery, and a Bachelor of Science in Pharmacy, from Uppsala University in Sweden. She is fluent in English and Swedish, as well as having a working knowledge of Danish and German.
Doug Ross MD, PhD
Chief Science Officer
Prior to joining Oncocyte, Dr. Doug Ross was a founding principal in the Bethesda Group, LLC, a boutique consulting firm that provided technical, commercial and operational expertise to the diagnostic and pharma industry. He is an experienced medical diagnostics R&D executive with a background in research and development at the intersections between genomics, proteomics and diagnostics.
He co-founded a successful genomics-based diagnostic business, served in executive leadership positions in CLIA reference laboratories, and managed proprietary content through research, development and launch.
Doug’s private sector career started in 2000 as Chief Scientific Officer of Applied Genomics, Inc. (AGI), a company he co-founded coming out of post-doctoral training at Stanford University. AGI translated insights from gene expression patterns into immunohistochemistry multivariate assays targeted to actionable clinical problems.
In 2009, Clarient, Inc., a leading national pathology reference laboratory, acquired AGI. Doug continued his role as Chief Scientific Officer and launched two proprietary products. General Electric Healthcare acquired Clarient in December 2010, and Doug continued as CSO and worked closely with the business development and partnership teams at Clarient and capital teams at GE Healthcare.
In 2011 Doug joined the Medical Science Division of Life Technologies as CSO on a consulting basis until the acquisition of Life Tech by Thermo Fisher Scientific in 2013. He was CSO of CardioDx, Inc. from April to December of 2014. In September 2015, Doug became a founding principal in Bethesda Group, LLC.
Doug obtained his M.D. and his Ph.D. in Pathology from the University of Washington while studying at the Fred Hutchinson Cancer Research Center in Seattle, WA. He completed two years of Clinical Pathology training including serving as Chief Resident at the University of California at San Francisco before joining the genomics project as a post-doc with Patrick Brown at Stanford University in 1996.
Chief Commercial Officer
Padma has extensive experience in commercializing and driving market leadership for molecular diagnostics at Roche Sequencing, Guardant Health, and Affymetrix.
At Oncocyte, Padma commercialized and secured positive Medicare coverage for DetermaRx, the 1st and only test for predicting risk of recurrence in early-stage lung cancer. Since its launch in 2020, the test has been adopted by over 300 physicians in the United States. She is leading the commercialization and reimbursement for the company’s pan-cancer diagnostic tests for immunotherapy selection and blood-based monitoring.
Before Oncocyte, Ms. Sundar has had leadership roles in marketing, product management, and global commercialization. As Vice President of Marketing and Market Access at CellMax Life, she launched the first blood test for preventative colon cancer screening. Prior to that, Padma was responsible for Marketing the Guardant360 liquid biopsy at Guardant Health, where she helped establish the test and liquid biopsy as standard of care. Padma also led product management at Roche Sequencing, partnering with Stanford University to launch the first next-generation sequencing (NGS) liquid biopsy kits for cancer treatment selection and blood-based recurrence monitoring. She also led the oncology portfolio at Affymetrix. She brought the first whole-genome microarray kits, “OncoScan” and “CytoScan” for solid and liquid tumor profiling, to 50 leading academic and reference labs worldwide.
Ms. Sundar began her career as a management consultant for McKinsey and Company. She served a variety of biopharma clients. She received her M.B.A. and M.P.H. from the University of California, Berkeley, and her B.A. in Chemistry from the University of Delhi.
David R. Gandara
Dr. David R. Gandara is a Professor of Medicine Emeritus at the University of California at Davis School of Medicine and the Director of Thoracic Oncology at the UC Davis Comprehensive Cancer Center (UCDCCC). He is an internationally known clinician-scientist and lung cancer thought leader.
He has led many notable research projects in lung cancer, including early therapeutics trials at various phases, cooperative group trials through the Southwest Oncology Group (SWOG), and multi-institutional translational science projects.
Dr. Gandara has been selected for many awards and honors, including the lifetime Scientific Award from the International Association for the Study of Lung Cancer (IASLC). He is the principal investigator for a National Cancer Institute (NCI) UG1 award to UCDCCC for Cancer Clinical Trials. He also is currently the principal investigator for UCDCCC for the Stand Up To Cancer (SU2C) dream team award in KRAS-mutated lung cancer, and served as clinical director for the joint Jackson Laboratory (JAX)-UCDCCC patient-derived xenotransplant (PDX) program in lung cancer. He is past chair of the Southwest Oncology Group (SWOG) Lung Committee, and is founding co-chair and current member of the NCI-directed Investigational Drug Steering Committee (IDSC).
Dr. Gandara has written over 700 articles, book chapters, abstracts and editorials. He is past editor-in-chief of the journal Clinical Lung Cancer. He served as president of the IASLC from 2009-2011 and served as treasurer from 2013–2017. He is a prior member of the board of directors and secretary-treasurer of the American Society for Clinical Oncology (ASCO).
Robert L. Ferris
MD, PhD, FACS
Dr. Robert L. Ferris is the Director of UPMC Hillman Cancer Center. He is also Hillman Professor of Oncology, and Professor of Otolaryngology, of Immunology, and of Radiation Oncology. Certified by the American Board of Otolaryngology, he treats patients with benign and malignant tumors of the head and neck, including the thyroid and salivary glands, oral cavity, throat and voice box (larynx).
He regularly performs robotic, endoscopic, minimally invasive approaches to thyroidectomy and partial laryngectomy, in order to preserve function and speed the return of speaking, swallowing and breathing.
Dr. Ferris is also developing and implementing immunotherapy (cancer vaccines) to treat head and neck tumors. His research focus is in trying to understand how to stimulate the body’s immune system to eliminate cancer. The goals of this research are to boost the body’s immune response against cancer and to try to prevent cancer from recurring (or to prevent it from occurring in the first place).
Dr. Ferris was trained at Johns Hopkins, where he received his MD and PhD in Immunology, a residency in Otolaryngology/Head and Neck Surgery, and subspecialty training in head and neck oncologic surgery.
Daniel F. Hayes
MD, FASCO, FACP
Dr. Daniel F. Hayes is the Stuart B. Padnos Professor of Breast Cancer Research at the University of Michigan Rogel Cancer Center. Dr. Hayes received undergraduate, master’s and medical degrees from Indiana University, followed by a residency in internal medicine at the University of Texas Health Science Center/Parkland Memorial Hospital and a fellowship in medical oncology at Harvard’s Dana Farber Cancer Institute (DFCI).
He has led the breast cancer programs at DFCI (1991-1996), Georgetown University’s Lombardi Cancer Center (1996-2001), and the University of Michigan from 2001-2016.
Dr. Hayes’ research interests are in the field of experimental therapeutics and cancer biomarkers, especially in breast cancer. His work has been particularly focused on development and validation of cancer biomarker tests, such as HER-2, CA15-3, circulating tumor cells and pharmacogenomic markers. He has been instrumental in establishing international guidelines for the use of tumor biomarker tests, including criteria for their clinical utility.
Dr. Hayes has served as chair of the SWOG Breast Cancer Translational Medicine Committee, and he was an inaugural member and chaired the American Society of Clinical Oncology (ASCO) Tumor Marker Guidelines Committee. Dr. Hayes served on the ASCO Board of Directors, and served a 3 year term as President of ASCO from 2016-2018. He is a Fellow of ASCO, a Fellow of the American College of Physicians, a past Komen Scholar, and a member of the Association of American Physicians and the American Clinical and Climatologic Association. He was the inaugural recipient of the ASCO Gianni Bonadonna Award in breast cancer.
Fred R. Hirsch
Dr. Fred R. Hirsch is Executive Director at the Center for Thoracic Oncology in The Tisch Cancer Institute at Mount Sinai (TCI) and the Joe Lowe and Louis Price Professor of Medicine (Hematology and Medical Oncology) at the Icahn School of Medicine at Mount Sinai. He is also Associate Director of Biomarker Discovery for TCI.
Before joining Mount Sinai, Dr. Hirsch was a Professor of Medicine and Pathology at the University of Colorado for 18 years and Chief Executive Officer of the International Association for the Study of Lung Cancer (IASLC) for five years.
Dr. Hirsch has received a number of awards and honors, including the IASLC Mary Matthews Award for Translational Research in Lung Cancer in 2007; the Japanese Lung Cancer Society Merit Award in 2010; the Addario Foundation Lecture Award in 2015; and the Wuan Ki Hong Lectureship Award in 2019. He has contributed to more than 400 publications in peer-reviewed journals. He is an internationally renowned authority on lung cancer treatment and research.
Dr. Hirsch’s career in lung cancer research spans more than 25 years and includes translational research, targeted therapies, and early detection of lung cancer. His research has helped identify and validate prognostic markers for lung cancer outcomes and biomarkers for personalized lung cancer therapies that illustrate how these therapies work and who is most likely to benefit from them.
John M. Kirkwood
Dr. John M. Kirkwood took his MD at Yale University (1973) and completed postgraduate work at Harvard/Dana-Farber Cancer Institute (1978). He served as the founding Associate Director and Chief of Medical Oncology at UPMC Hillman Cancer Center, where he has directed the Melanoma and Skin Cancer Program since 1986, and served as PI of the Pittsburgh SPORE in Melanoma and Skin Cancer (2008-2019) and held T32 Training Grants for Medical Oncology and for Melanoma and Skin Cancer.
Dr. Kirkwood is Principle Investigator for ECOG-ACRIN at the University of Pittsburgh and Co-PI of the Lead Academic Performing Site (LAPS) at the University of Pittsburgh (2019-present). He has been Chairman of the ECOG-ACRIN Melanoma Committee (1989-2019) and assumed the position of Chairman of the ECOG-ACRIN Prevention Subcommittee in 2019. He founded the International Melanoma Working Group and has chaired this (2005-present); he founded the Regional Melanoma Consortium of tristate institutions and has chaired this 2014-present, bringing new collaborative trials to the region.
Dr. Kirkwood’s research focuses upon the immunotherapy and molecular therapy of advanced melanoma, and the development of adjuvant therapies as well as the therapeutic prevention and early detection for melanoma. He has led >300 trials of investigational therapy, with an emphasis upon immunotherapy and molecular/immunological translational research. He has developed new approaches to adjuvant and neoadjuvant therapies at UPMC Hillman Cancer Center, and in the National Clinical Trials Network through ECOG-ACRIN. Dr. Kirkwood was the PI for the pivotal study that led to the first FDA approval for adjuvant therapy of melanoma with IFN alfa-2b in 1995 and was senior author of the most recent adjuvant trial leading to approval of molecularly targeted adjuvant therapy in 2018 (Combi-AD).
Dr. Kirkwood is Distinguished Service Professor of Medicine and Usher Professor of Medicine, Dermatology, and Translational Science at the University of Pittsburgh. He was elected to the Association of American Physicians in 2015 and to the Giants of Cancer Care in 2016. He is currently a member of multiple professional organizations including the American Society of Clinical Oncology, American Association for Cancer Research, Society for Immunotherapy of Cancer and the Society for Melanoma Research.
Dr. Heinz-Josef Lenz is the Associate Director for Clinical Research and Co-leader of the Translational Science Program at the USC Norris Comprehensive Cancer Center. Dr. Lenz is Professor of Medicine and Preventive Medicine, J Terrence Lanni Chair for Cancer Research in the Division of Medical Oncology and Co-Director of the Colorectal Center at the Keck School of Medicine of the University of Southern California.
An active researcher, Dr. Lenz’s National Cancer Institute-funded laboratory is developing novel agents in his preclinical models in GI cancer. Lenz, a transformational clinical investigator and translational scientist, was the first to measure intratumoral RNA levels associated with efficacy of 5-FU and oxaliplatin and led the first prospective randomized Phase II trials using gene expression from FFPE specimens. He also discovered that primary tumor location of colorectal cancer (CRC) is an independent predictive and prognostic marker, now in the NCNN guidelines. His paper on Consensus Molecular Subtyping identified novel subgroups that are predictive and prognostic in CRC, now used globally in drug development. He has been the Co-PI of the UG1 CA 062505 for the last 20 years and leads the NCCC site for the NCI UM1 (CA186717 with City of Hope, (UC Davis), and Stanford. He is Chair of the Translational Medicine Subcommittee in SWOG GI, member of the NCI Gastroesophageal Task Force and Clinical Trial Planning Committee, as well as the Investigational Drug Steering Committee. Lenz accelerates translational and clinical research, and provides training and mentoring in the design and implementation of investigator-initiated trials.
Dr. Lenz earned his M.D. degree at the Johannes-Gutenberg Universität in Mainz, Germany. In 1991, he completed his internship, residency and fellowship training at the Eberhardt Karls Universität in Tübingen, Germany. He obtained special fellowship training at Universität Wien (Austria), George Washington University and Harvard Medical School. In 1991, he received the prestigious Research Fellowship Award from the “Deutsche Krebshilfe” (Bonn, Germany). He completed his research fellowship in biochemistry and molecular biology at the USC Norris Comprehensive Cancer Center before joining the faculty of USC in 1994. He was awarded a Career Development Award from STOP CANCER (1994-1997). Based on his research, he also received a Young Investigator Award from the American Society of Clinical Oncology (ASCO) in 1994. In 1995, Dr. Lenz was selected for the prestigious ASCO Career Development Award, as well as an NIH Mid-Career Development Award. He has published over 540 peer reviewed manuscripts with an h-index of 101.
Ignacio I. Wistuba
Dr. Ignacio I. Wistuba is Head ad interim of the Division of Pathology and Laboratory Medicine, Professor and Chair of the Department of Translational Molecular Pathology with Joint appointment in the Department of Thoracic/Head and Neck Medical Oncology, and co-director of the Khalifa Institute of Personalized Cancer Institute at the University of Texas MD Anderson Cancer Center.
He is also the director of the Thoracic Molecular Pathology Laboratory, director of the UT Lung Specialized Programs of Research Excellence (SPORE) Tissue Bank, director of the ECOG-ACRIN (Eastern Cooperative Oncology Group-American College of Radiology Imaging Network) Central Biorepository and Pathology Facility, pathologist for the SWOG Lung Cancer Committee and the Lung Cancer Mutation Consortium, co-director of the pre-CLIA Genomic Testing Developmental Laboratory. He is associate editor of Annals of Oncology and Cancer Prevention Research.
Dr. Wistuba’s major research interest is the elucidation of the molecular abnormalities involved in the pathogenesis and progression of lung cancer and other solid tumors. He has co-authored over 600 papers in peer-reviewed journal and several book chapters. His research interests also include identifying new molecular targets, validating biomarkers for targeted therapy and immunotherapy, and identifying molecular markers associated with lung cancer and other solid tumors development, progression and metastasis development using annotated human specimens. He is principal investigator (PI) and co-PI on several molecular pathology and biomarker projects supported by multi-investigators and multi-institutional grants, and research agreements, including MD Anderson NCI Cancer Center Support Grants Tissue Bank and Pathology Resource, Cancer Prevention and Research Institute of Texas Multi-Investigators Research Awards, two NCI-U24 grants supporting the ECOG-ACRIN Central Biorepository and Pathology Facility and the MD Anderson Center Immune Monitoring and Analysis Center (CIMAC).