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Stony Brook Enters Licensing Agreement with OncoGenesis for Use of Cancer Biomarker

Molecular diagnostics company plans to utilize biomarker in new multiplex cervical cancer tests

Stony Brook, NY, and Morgan Hill, CA, September 17, 2015 – Stony Brook University has entered into an exclusive licensing agreement with molecular diagnostics company OncoGenesis Corporation, on the use of the protein biomarker Keratin 17 (K17) for diagnostic and prognostic applications for cervical cancer. These applications will be developed based on the research of Kenneth Shroyer, MD, PhD, Professor and Chair of the Department of Pathology, and colleagues at Stony Brook University School of Medicine.

Cervical cancer is the second most prevalent form of cancer found in women worldwide. Treatment for the disease is highly effective if detected early, yet over 250,000 die annually because current diagnostic methods used for the detection and treatment of cervical cancer are ineffective. In addition, these tests are not readily available in many parts of the world because they require a trained professional to run and interpret. Therefore, new diagnostics are needed.

keratin license
Dr. Kenneth Shroyer and Luisa Escobar-Hoyos, a graduate student in Pathology, led the research at Stony Brook University on K17 as a biomarker of cancer.

Dr. Shroyer and colleagues discovered that K17 promotes cancer and plays a crucial role in degrading a key tumor suppressor protein. Details of this research are featured in a recent issue of Cancer Research and in this press release. They also found that K17 cervical cancer patients have a decreased chance of long-term survival when compared to patients who express little to no K17 in tumor tissue. This led the team on a path to identify K17 as a specific biomarker of cervical cancer.  

“We believe that K17 has extraordinary clinical potential as a diagnostic and prognostic biomarker for cervical cancer,” said Dr. Shroyer. He and graduate student Luisa Escobar-Hoyos will present supportive research findings in two platform presentations on September 18 at the 30th International Papillomavirus (HPV) Conference in Lisbon, Portugal. Luisa will present a third platform presentation on September 19th.

“Our research on the role of K17 in cancer will continue, and we suspect to discover more about K17 specific to cervical cancer, which will help us to advise OncoGenesis on other approaches to developing clinical applications,” added Dr. Shroyer.

OncoGenesis is developing a comprehensive solution ranging from optimal specimen collection to point-of-care diagnostic testing that the company hopes will set a new standard of care for the diagnosis and treatment of cervical cancer worldwide. At the heart of the solution is the CerMark™ multiplex molecular cervical cancer screening test that evaluates protein biomarkers from cervical cells. The test measures multiple protein biomarker levels to profile the critical cellular changes in a cervical cell specimen. For example, by quantifying K17 protein levels in high-grade cervical cells, and correlating these levels with cervical cancer patient survival, the test will provide clinicians actionable diagnostic and prognostic information to effectively screen and manage their patients for cervical cancer.

“We are excited to continue our long and successful relationship with Stony Brook and Dr. Shroyer and for the opportunity to utilize proprietary biomarkers such as K17 in our cervical cancer test.” said Dr. Nam W. Kim, OncoGenesis’ Senior Vice President of Technology. “The addition of the K17 biomarker onto our CerMark multiplex test will further improve the accuracy and performance of our test in detecting cervical cancer. We believe that providing clinicians with this information at the point-of-care will revolutionize the screening and management of women for cervical cancer worldwide.”

OncoGenesis plans to begin clinical testing of its CerMark test in late 2015.

About Stony Brook University School of Medicine
Established in 1971, the Stony Brook University School of Medicine includes 25 academic departments. The three missions of the School are to advance the understanding of the origins of human health and disease; train the next generation of committed, curious and highly capable physicians; and deliver world-class compassionate healthcare. As a member of the Association of American Medical Colleges (AAMC) and a Liaison Committee on Medical Education (LCME) accredited medical school, Stony Brook is one of the foremost institutes of higher medical education in the country. Each year the School trains nearly 500 medical students and more than 480 medical residents and fellows. Faculty research includes National Institutes of Health-sponsored programs in neurological diseases, cancer, cardiovascular disorders, biomedical imaging, regenerative medicine, infectious diseases, and many other topics. Physicians on the School of Medicine faculty deliver world-class medical care through more than 30,000 inpatient, 80,000 emergency room, and approximately 350,000 outpatient visits annually at Stony Brook University Hospital and affiliated clinical programs, making its clinical services one of the largest and highest quality on Long Island, New York. To learn more, visit www.medicine.stonybrookmedicine.edu.

About OncoGenesis
Founded in 2008, OncoGenesis is focused on addressing the tremendous, unmet clinical need for easy and accurate screening of women for cervical cancer. The company has developed a multiplex biomarker test that measures the critical cellular changes in a cervical tissue specimen.  By measuring these markers, the test will be able to detect the presence of cervical cancer and precancerous high-grade lesions as well as the progression (staging), and aggressiveness of the disease.

RELATED LINKS:  Stony Brook University Newsroom



OncoGenesis Appoints New President & COO

Morgan Hill, CA, August 27, 2015 — OncoGenesis, the developer of a new approach for multiplex molecular cervical cancer screening, announced today that it has appointed S. Wayne Kay as its President & Chief Operating Officer effective September 1st

“We are excited that Wayne will be joining OncoGenesis as our President and COO,” noted Peter Gombrich, OncoGenesis’ founder and CEO.  “Wayne has served as President and CEO of several successful new technology diagnostic companies.  He brings a wealth of experience that will be valuable as we begin the commercialization of our innovative biomarker approach to cervical cancer detection.”  Most recently Mr. Kay was the Founding President and CEO of Wireless Diagnostic Systems Inc., and s2a molecular, both new technology spin-outs from California Institute of Technology.  

It was also announced that Thomas Umbel, former President and COO of the company, will continue his position on the OncoGenesis’ Board of Directors.

In addition to appointing a new President & COO, OncoGenesis recently added two new members to its commercialization team.  Last month Nico Arnold joined the company as Senior Vice President, Business and Market Development, and Brian Sunkel as Vice President, Marketing and Business Development.  Nico has over 30 years experience in the diagnostic industry. Most recently he was the EVP Global Commercial Operations for Cepheid.  Brian brings over 25 years of success in commercializing novel technologies including his work with women’s health diagnostic company Adeza Biomedical where he was their Director of International Sales & Marketing when the company was acquired by Cytyc/Hologic.

About OncoGenesis

Founded in 2008, OncoGenesis is focused on addressing the tremendous, unmet clinical need for easy and accurate screening of women for cervical cancer.  The company has developed a multiplex biomarker test that measures the critical cellular changes in a cervical tissue specimen.  By measuring these markers, the test will be able to detect the presence of cervical cancer and precancerous high-grade lesions as well as the progression (staging), and aggressiveness of the disease.


CerMed Announces Corporate Name Change and Names President

SUNNYVALE, Calif., June 5, 2014 /PRNewswire/ — CerMed is pleased to announce its new corporate name – OncoGenesis.  According to Founder and Board Chairman Peter Gombrich, “The name OncoGenesis better articulates our broader focus beyond point-of-care cervical cancer screening, to include cancer diagnostics and personalized directed therapeutics.  We have made great progress over the past year demonstrating the efficacy of our CerMark™ multiplexed biomarkers which were previously proven on histology samples and now with cytological patient samples.  This point-of-care test will run on the company’s microfluidics-based platform, utilizing a proprietary and highly sensitive novel non-optical sensor,” continued Mr. Gombrich.

The company is also pleased to announce the appointment of Thomas Umbel as President and COO.  Tom comes to OncoGenesis with over 35 years of multi-discipline experience in companies ranging in size from start-ups to major global corporations.

For the past 15 years, Tom has held various senior management positions at Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostic products with an emphasis on serving the healthcare needs of women throughout the world.  Tom joined Hologic through the successful sale of Direct Radiography Corp where he served as Vice President and General Manager.  In 2002, Tom was promoted to Group SVP for Business Development.  Amongst his most notable achievements in this role were the successful acquisitions of Cytyc Corp ($6.6 Billion) and GenProbe ($3.8 Billion).

“We are very fortunate to have someone of Tom’s experience and credentials join our company,” said Peter Gombrich.  Adding, “Tom brings deep experience in women’s health to OncoGenesis. As we expand beyond cervical screening he will be instrumental in leading the company to the next level.”

“I am very pleased to be joining this exciting venture,” said Umbel.  “The OncoGenesis team is comprised of successful managers, scientists and engineers backed by an exceptional group of global scientific and medical advisors.  I look forward to leading this team in bringing these breakthrough technologies to market.”

About OncoGenesis

Formerly CerMed (founded in 2008), OncoGenesis is a global company focused on the development of multiplexed biomarker-based systems that identify the presence and progression of cancer.  The company’s focus addresses the great, unmet need for identifying and treating cancers in women: cervical, uterine, ovarian, endometrial and breast. The initial opportunity will focus on cervical cancer screening, replacing the current 160M global pap smears performed each year.