THE BLOG

01
Aug

A Message from the President and CEO

At OncoCell MDx, we are answering the challenge of putting more in-depth information about disease pathology into physician and patient hands by delivering tools that optimally stratify disease. The company was founded around an immunogenomic platform invented at Harvard Medical School, in which gene expression patterns of white blood cells are interrogated after a noninvasive blood draw is taken from a patient. Leveraging a proprietary algorithm, the assay provides real surveillance of immune response changes, identifies the cause of disease, and filters out non-relevant noise. Our mission is to help patients live higher quality lives by providing highly accurate, less painful ways to screen, diagnose, and monitor prostate cancer and other diseases.  

I joined OncoCell MDx in late April with the goal to leverage my expertise in cancer, genetics, molecular diagnostics and team building to create a special company. I’m here with some of the best respected names in diagnostics and in oncology. I was fortunate to bring over Chris Thibodeau to the team earlier this month, along with Dr. Kirk Wojno, a key opinion leader in prostate cancer diagnosis. Marc Stapley just joined our Board of Directors, and Geff Erickson, a Founder and longtime contributor to the company, will be staying on to lead Corporate Development and investor outreach. I look forward to working together with my team to make a global impact addressing clinical, operational and cost issues in disease diagnosis.

In the coming year, we will launch our first product, a unique assay that uses a simple blood draw to detect, grade and understand the aggressiveness of prostate cancer. Our goal is to immediately reduce the frequency of – and eventually replace – invasive, expensive and imprecise diagnostic procedures. We endeavor to help physicians make better and more timely decisions about who and how to treat, preclude over treatment, potentially reduce deaths related to under treatment, and ultimately enhance the effectiveness of treatment. In so doing, we aim to give patients their lives back. And while our approach is to always prioritize the highest value immediate opportunity, we’re also leveraging the platform to develop new assays for other cancers and disease. We’ve amassed a broad IP portfolio, including rights from Harvard to 45 issued patents and more than 100 pending applications in the United States and internationally. These issued and pending patents cover various aspects of our technology in numerous clinical indications including cancer, cardiovascular, infectious, and neurodegenerative disease, and immune- and kidney-related diseases.

To make manifest our mission to develop and deliver transformational solutions that improve lives, we need dedicated, engaged people organized around an audacious purpose and game changing technology. We have that here at OncoCell MDx and I’m privileged and excited to lead this highly skilled, highly motivated team into our next stage of clinical and corporate development.

I look forward to keeping you apprised of our progress.

Mark

18
Jul

OncoCell MDx Appoints Renowned Urologic Pathologist as Chief Medical Officer

ROYAL OAK, Mich., — July 18, 2019 — OncoCell MDx, an immunogenomics platform company specializing in the delivery of novel, noninvasive molecular diagnostic assays, today announced that Kirk Wojno, M.D., has joined the company’s leadership team as its Chief Medical Officer. Dr. Wojno, a renowned urologic pathologist and expert in prostate biopsy interpretation, joins an expanding, experienced executive team. OncoCell MDx also recently announced the appointments of Mark McDonough as President and CEO and Christopher Thibodeau as Chief Operating Officer.

“OncoCell is in an exciting phase of growth. We are moving toward commercialization of our first immunogenomics test for prostate cancer, and we are continuing to develop our pipeline of noninvasive tests for other cancers and diseases,” said McDonough. “Dr. Wojno brings a wealth of knowledge of the company and the space, an illustrious reputation, expert knowledge of anatomic and molecular pathology, and deep experience running clinical affairs and laboratory operations. I’m really pleased to work with him, with Christopher and with the rest of the OncoCell team to drive transformational advances in patient care.”

Dr. Wojno is a nationally renowned pathology expert in prostate cancer. He is the former head of Urologic Pathology at the University of Michigan, at Ascension Health System, and at national Ameripath Laboratories. He has more than 30 years in medical practice and most recently served as the Chief of Pathology and Laboratory Services and Director of Clinical Research for Comprehensive Urology located in Royal Oak, Michigan, one of the largest urology group practices in the United States. While at Johns Hopkins University, Dr. Wojno trained with the Brady Institute’s Jonathan Epstein, M.D. an internationally recognized authority in uropathology. Dr. Wojno received his medical degree from Wayne State University School of Medicine.

“Screening, diagnosis and management of prostate cancer continues to be challenging due to tumor heterogeneity and complexity,” said Kirk Wojno, M.D. “As a practicing pathologist over the past three decades, I’m delighted to work with OncoCell in addressing a significant need to improve patient selection for active surveillance and to provide a noninvasive method for annual monitoring. Our goal is to help reduce overtreatment of indolent disease along with patient anxiety. I am equally excited about the promise this technology offers across a broad spectrum of diagnostic indications, from cancer, cardiovascular, infectious and neurodegenerative disease, to immune- and kidney-related diseases.”

About OncoCell MDx:

OncoCell MDx is a privately held company developing and commercializing novel diagnostic tests utilizing proprietary technologies created at Harvard Medical School by OncoCell MDx’s founder, Professor Amin I. Kassis. The company’s noninvasive blood-based immunogenomic assays are designed to aid physicians to better understand underlying disease pathology in prostate cancer and other oncology and non-oncology indications. For more information about OncoCell MDx and its technology, visit: https://oncocellmdx.com/.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190718005153/en/OncoCell-MDx-Appoints-Renowned-Urologic-Pathologist-Chief

Contact:
Virginia Amann for OncoCell MDx
VirginiaAmann@ENTENTEInc.com
M: +1.608.207.0082 (preferred)

O: +1.312.416.8438

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09
Jul

OncoCell MDx Prepares for Commercialization with Appointment of Christopher Thibodeau as Chief Operating Officer

ROYAL OAK, Mich., – July 9, 2019 – OncoCell MDx, an immunogenomics platform company specializing in the delivery of novel, noninvasive molecular diagnostic assays, today announced the appointment of Christopher Thibodeau as its Chief Operating Officer. He joins Mark McDonough, recently appointed as OncoCell’s President, Chief Executive Officer and member of the Board of Directors, in strengthening the company’s executive leadership team.

“OncoCell continues to build a world class management team as we develop our pipeline of noninvasive assays and drive toward commercialization,” said Mark McDonough, President and CEO of OncoCell MDx. “Christopher is a proven commercial operator with an impressive record of leading successful product launches, both domestically and internationally. He has an outstanding reputation within the molecular diagnostics industry, and especially within the urology community, where we will launch our first immunogenomics test for prostate cancer.”

Christopher has more than 25 years of successful commercial operations experience. He most recently served as Chief Operating Officer for MDxHealth, a publicly traded multi-national molecular diagnostics company that specializes in epigenetic testing solutions for urologic oncology. He was responsible for establishing the company’s commercial operations and led the team that developed, validated and launched the company’s first prostate cancer test. Chris led initiatives to navigate the MolDX program to capture Medicare coverage, gain NCCN Guideline inclusion, obtain a unique CPT billing code, and secure broad reimbursement coverage while driving market adoption with over 4,000 urologists across the US. Previously, Christopher held various leadership positions at Agendia, Numira Biosciences, US LABS (LabCorp) and Ventana Medical Systems (Roche).

“OncoCell has developed a unique non-invasive assay leveraging an immunogenomics platform developed at Harvard Medical School that has potential to significantly improve the way cancer and neuro degenerative disease is managed. I am excited to join the team in addressing a significant unmet need for oncologists, urologists and their patients,” stated Christopher Thibodeau. “In prostate cancer, where there is ongoing controversy on prostate cancer screening and overtreatment, Active Surveillance is one of the fastest growing patient management pathways for men with early stage disease. Unfortunately, monitoring tools available to urologists today carry a high cost, morbidity and leave patients at risk for disease progression. OncoCell’s proprietary noninvasive blood test, which can be used to set a baseline and then monitor patients annually, will help urologists improve patient care and overall outcomes.”

About OncoCell MDx

OncoCell MDx is a privately held company developing and commercializing novel diagnostic tests utilizing proprietary technologies created at Harvard Medical School. The company’s noninvasive blood-based immunogenomic assays are designed to aid physicians to better understand underlying disease pathology in prostate cancer and other oncology and non-oncology indications. For more information about OncoCell MDx and its technology, visit: https://oncocellmdx.com/.

View source version on businesswire.com:

https://www.businesswire.com/news/home/20190709005278/en/OncoCell-MDx-Prepares-Commercialization-Appointment-Christopher-Thibodeau

30
Apr

OncoCell MDx Announces Mark McDonough as New President & Chief Executive Officer

Royal Oak, Mich. (April 30, 2019) – OncoCell MDx, a company developing novel noninvasive diagnostic and prognostic tests by harnessing the power of the immune system, today announced the appointment of Mark McDonough as its president, chief executive officer (CEO) and member of the Board of Directors. McDonough succeeds company co-founder, investor and Chairman/CEO Harry Stylli, Ph.D. Stylli continues as the executive chairman of the company.

“Since OncoCell’s founding, we have built an outstanding research and development capability and advanced a proprietary platform that exploits the power of the immune system and machine learning to non-invasively identify robust disease signatures for many pathologies. Although the platform has the capability to target any analyte, we chose to exploit gene expression. To date we have analyzed about 2,000 patient samples to identify a unique immunogenomic signature that can discriminate subjects with indolent and aggressive prostate cancer from normal controls. With the presentation of promising results from our recent study at the American Association for Cancer Research Annual Meeting, we demonstrated the potential of our technology to aid in early detection and progression of disease pathology,” said Stylli.

“Mark has an outstanding track record in generating significant value at both large and small companies in the molecular diagnostics field and especially for companies like ours that are approaching commercialization,” he added. “I’m excited that he will lead OncoCell MDx in our mission to bring novel technologies to market that help physicians better manage patients with prostate cancer and other pathologies.”

McDonough most recently served as the chief business officer at Phosphorus, a genomic health company, where he helped increase the company’s revenue by more than tenfold in less than a year. Prior to joining Phosphorus, McDonough served as chief executive officer and president of CombiMatrix, a publicly held molecular diagnostics company performing DNA-based testing services for reproductive health and developmental disorders, through its acquisition by Invitae Corp. He also held executive and management positions with US LABS (acquired by LabCorp) and Ventana Medical Systems (acquired by Roche) as well as Pathwork Diagnostics.

“OncoCell’s platform facilitates not just detection, but also grading and aggressiveness of disease, leading to more timely and better directed medical decision making. I’m inspired by the company’s potential to improve the quality, effectiveness and efficiency of patient care, and I’m humbled to lead what is already a very strong team into our next stage of clinical and corporate development,” McDonough said. “I would like to thank the Board and Harry Stylli for the opportunity to build on the company’s successes and momentum as we continue to move OncoCell MDx forward.”

McDonough is currently an advisor for Phosphorus and Natal Health. He is a former navigator in the U.S. Navy and holds a B.S. in Finance from Miami University.

About OncoCell MDx

OncoCell MDx is a privately held company developing and commercializing novel diagnostic tests utilizing proprietary technologies created at Harvard Medical School.  The company’s noninvasive blood-based immunogenomic assays are designed to aid physicians to better

02
Apr

OncoCell Announces Late-Breaking Poster Presentation at AACR 2019 on a Noninvasive Blood-Based Assay for Prostate Cancer Prognosis

April 1, 2019 – ATLANTA – OncoCell MDx, a company developing novel noninvasive diagnostic and prognostic tests, will present results from a feasibility study of a new prostate cancer prognostic assay in a late-breaking poster session at the American Association of Cancer Research (AACR) Annual Meeting tomorrow. The study demonstrates that the blood-based immunogenomics RNA expression assay provides a prognostic summary comparable to that of prostate biopsy.

OncoCell’s Subtraction-Normalized Expression of Phagocytes (SNEP) based platform, invented by Professor Amin Kassis, while at Harvard Medical School, uses a proprietary algorithm to interrogate changes in gene expression of two immune cell types consequent to prostate cancer including phagocytic (CD14) and non-phagocytic (CD2) cells, filters out intrinsic genomic variation not related to the disease, and identifies and validates prostate cancer-specific signatures. A study of blood samples from 713 prostate cancer patients showed the platform provides a prognostic summary including tumor Gleason grade distribution, size/volume and heterogeneity that is comparable to prostate biopsy information, and that it stratifies patients with aggressive disease that need life-saving treatment from those with indolent disease.

In the study, CD2 and CD14 cells were isolated from peripheral blood samples and mRNA samples were extracted and sequenced from each cell type. Transcripts with quantifiable expression changes were used to train OncoCell’s proprietary SNEP-based algorithm to stratify the patients into those who need treatment versus surveillance. A genomic signature was identified that is predictive of Gleason grade, cores positive and maximum involvement. Signature scores were significantly associated with these endpoints and an Aggressiveness Index that incorporates the three endpoints. Samples from two independent sets of naïve patients (n=305 and n=470) validated the results.

“We are encouraged by the results of these study findings, which suggest this assay may play an important role in advancing clinical management of prostate cancer patients,” said Philip Kantoff, M.D., Clinical Advisor to OncoCell and Chair of the Department of Medicine, Memorial Sloan Kettering Cancer Center.

Details of the study are being presented April 2 from 1:00 p.m. to 5:00 p.m. EDT in a poster session titled “Immuno-genomic detection and prognostication of aggressive prostate cancer phonotypes by next-generation RNA sequencing” (https://www.abstractsonline.com/pp8/#!/6812/presentation/9127)at theGeorgia World Congress Center, Exhibit Hall B, Poster Section 41, Poster Board Number 19.

The poster will be made available on the company’s website at www.oncocellmdx.com.

About OncoCell MDx

OncoCell MDx is a privately held company developing and commercializing novel diagnostic tests utilizing proprietary technologies created at Harvard Medical School.  The company’s noninvasive blood-based immunogenomic assays are designed to aid physicians to better understand underlying disease pathology in prostate cancer and other oncology and non-oncology indications.

Press Contact:
Virginia Amann for OncoCell MDx
VirginiaAmann@ENTENTEInc.com
+1.608.207.0082