Clinical Genomics Announces Key Executive Appointments
-- Building management team to support development and commercialization of innovative liquid biopsy tests, COLVERA®, for colorectal recurrence monitoring, and TRIDENT, for colorectal screening --
BRIDGEWATER, N.J. — July 28, 2020 — Clinical Genomics (“CG” or the “Company”), a provider of cancer diagnostic solutions, including liquid biopsy tests for screening and recurrence monitoring of colorectal cancer (CRC), today announced key appointments to its executive team: Michael W. Paris, Chief Operating Officer; Zivjena Vucetic, MD, PhD, Senior Vice President - Medical; and Edward L. Rosen, Chief Strategy and Commercial Officer.
“We are delighted to welcome Mike, Zivjena and Ed to the Clinical Genomics team. Each brings unique skills and valuable expertise that will help us to advance our transformative portfolio of blood tests that address unmet medical needs in the colorectal cancer (CRC) screening and recurrence monitoring markets. Collectively, they bring a wealth of experience in the development of FDA-regulated products; manufacturing and supply chain operations; clinical trials and medical affairs; health economics and reimbursement; new product commercialization; and business development,” stated Betsy Hanna, Chief Executive Officer of Clinical Genomics.
These critical capabilities will be invaluable as we advance COLVERA® for CRC recurrence monitoring, and the TRIDENT CRC screening program toward significant commercial and development milestones in the coming months. CRC is the second- leading cause of cancer-related deaths in the United States(1). We know that timely diagnosis and identification of recurrences save lives, and Clinical Genomics is committed to ensuring that our superior diagnostics tests are available to health care providers and their patients,” concluded Hanna.
Michael Paris is an accomplished product development and operations executive with extensive experience in lifecycle management of innovative medical devices. He brings expertise in building and leading technology development and operations in early-stage ventures, as well as mature companies. Most recently, Mr. Paris served as Chief Operating Officer and Senior Vice President, Operations and Technology Development, at Origin Inc., a pre-revenue, biotechnology company. Prior to that, he held positions of increasing responsibility at Bioconnect Systems, Orthovita, Inc., which was acquired by Stryker Corporation in 2011, and Rex Medical. Mr. Paris received his B.S. degree in Mechanical Engineering Technology from Temple University, and an Executive M.B.A. from Lebow College of Business, Drexel University, where he is a Board Member.
Zivjena Vucetic is an experienced global medical, clinical and scientific affairs leader who has successfully created clinical value through novel diagnostic solutions across multiple disease areas, including oncology and neurodegenerative, cardiovascular and infectious diseases. She brings a depth of expertise in clinical development and post- market evidence generation for novel biomarker tests, including development and execution of clinical trial strategy, collaborations with thought leaders and academic investigators and developing medical education programs. Most recently, she served as a Medical Director at Ortho-Clinical Diagnostics, a global in-vitro diagnostics company, where she led clinical trial strategy for a broad portfolio of novel and routine laboratory tests. Prior to that, Dr. Vucetic was at Fujirebio Diagnostics, where she held several roles of increasing responsibility within scientific and medical affairs, focusing on value development of novel biomarkers, expanding and improving clinical utility of new or underutilized laboratory tests, and identifying potential new technologies through external collaborations. Dr. Vucetic holds an MD, from the University of Zagreb School of Medicine in Croatia and a PhD in Biochemistry from Temple University; she completed her Post-Doctoral Fellowship at the University of Pennsylvania School of Medicine.
Ed Rosen is an experienced global life sciences and oncology business leader with a proven track record in strategic planning, new product commercialization and P&L optimization. He has successfully led companies through periods of transformational growth, overseeing commercialization, innovation and product development across pharmaceutical, device and diagnostic businesses in key markets. He also brings broad experience in health economics and reimbursement, having initiated and navigated several national coverage determinations. Mr. Rosen is an entrepreneur who founded Glendevon Life Sciences LLC and co-founded, built and funded Elucida Oncology, Inc.® Most recently, he was an Executive in Residence at Columbia University, where he worked with entrepreneurs and inventors to facilitate the transfer of research innovations from the lab to the market, and to support start-up efforts across therapeutic, diagnostic and device applications. Prior to that, Mr. Rosen held positions of increasing responsibility at Johnson & Johnson, where he focused on oncologic immune cell therapy and circulating tumor cells for research and clinical use. Mr. Rosen holds a B.A. in Business Studies from the University of Lincoln, Hull, United Kingdom.
About Clinical Genomics
Clinical Genomics is dedicated to improving patient outcomes through early detection of colorectal cancer. Clinical Genomics’ products span the full spectrum of colorectal cancer testing from screening to post-treatment monitoring. Clinical Genomics is committed to developing and delivering solutions that provide physicians and their patients with information to help guide earlier and better treatment decisions in cancer care management.
COLVERA is the first of its kind blood test to detect circulating tumor DNA for minimal residual disease (“MRD”) assessment and recurrence monitoring in patients previously diagnosed with colorectal cancer. COLVERA targets aberrant methylation of two genes (BCAT1 and IKZF1) and is mutation agnostic. COLVERA does not require any form of tissue biopsy prior to use. Introduced in 2017, COLVERA has been ordered by hundreds of colorectal surgeons and medical oncologists across the United States.
About Colorectal Cancer
Colorectal cancer is the third most commonly diagnosed cancer and the second-leading cause of cancer-related deaths in the United States, with more than 140,000 people per year expected to be diagnosed with CRC and over 50,000 succumbing to the disease annually. For patients who survive, 30%-50% will experience a recurrence, most within the first two to three years of primary treatment. On average, the lifetime risk of developing colorectal cancer is about one in 23 for men and women combined; however, this varies widely according to individual risk factors.
Future Matters and Forward Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements that address expectations or projections about the future, including statements about product development, market position, expected expenditures and financial results, are forward- looking statements. Some of the forward-looking statements may be identified by words like “expects,” “anticipates,” “plans,” “intends,” “projects,” “indicates,” and similar expressions. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. These statements are not guarantees of future performance and involve a number of risks, uncertainties and assumptions. Accordingly, the Company’s actual results or performance may differ significantly, positively or negatively, from forward-looking statements made herein. Unanticipated events and circumstances are likely to occur. Factors that might cause such differences include, but are not limited to, anticipated funding proving to be unavailable; intense competition in the market resulting in lower than anticipated revenues or higher than anticipated costs; and general economic conditions, such as the rate of employment, inflation, interest rates and the condition of the capital markets. This list of factors is not exclusive. The Company undertakes no obligation to update any forward-looking statements.
Investor Relations for Clinical Genomics:
COLVERA is a registered trademark of Clinical Genomics Pathology PTY Ltd.
(1)American Cancer Society, Cancer Facts & Figures 2020. Atlanta, GA: American Cancer Society; 2020