An interview with Dr Stephen Epstein during the 2013 CRT conference. Both Dr Epstein and Dr Wilensky ( the interviewer) are members of FirstMark’s Scientific Advisory Board.

To view the video for this interview, please click the following link:

CRT 2013 Interview: Stephen E. Epstein, MD

“Each member of our prestigious Scientific Advisory Board has made extraordinary contributions to cardiovascular medicine and research. We are honored to have their expertise as we move into this next phase for PREvent.  It’s an exciting time for FirstMark, now that PREvent has gained momentum for clinical adoption, especially among primary care physicians and internists” says Thomas Silberg, President and CEO of GenWay Biotech. “PREvent’s launch was based on the remarkable data resulting from the 4-year, 3,414 cohort study at Emory University. We look forward to implementing plans based on the advice of our scientific advisors for the selected future trials that will uncover additional benefits of PREvent for coronary artery disease patients, and expand utility of the test to other patient populations. Most importantly, the future clinical validation studies are designed to provide evidence that PREvent can improve outcomes for patients tested with PREvent, and have an impact on overall health economics of coronary artery disease patients’ management.”

The FirstMark Scientific Advisory Board is comprised of prominent cardiologist and research scientists including:

George A. Beller, MD, MACC
Cardiologist, University of Virginia Health System
Past President of the American College of Cardiology
Past President of the Association of University Cardiologists
Past President of the Association of Professors of Cardiology

Stephen Epstein, MD
Executive Director of the Cardiovascular Research Institute (CRI), MedStar Health Research Institute
Clinical Professor of Medicine at the Georgetown University School of Medicine
Former Chief of the Cardiology Branch of the NHLBI at the National Institutes of Health in Bethesda, MD

Arshed Quyyumi, MD, FACC, FRCP
Tenured Professor of Medicine, Division of Cardiology, Emory University School of Medicine,
Co-Director, Emory Clinical Cardiovascular Research Institute

Prediman K. Shah, MD, FACC, FACP, FRCP
Director, Division of Cardiology at Cedars-Sinai Medical Center
Director, Oppenheimer Atherosclerosis Research Center at Cedars-Sinai Medical Center
Shapell and Webb Family Chair in Clinical Cardiology
Professor, Cedars-Sinai Professorial Series

Sergey Sikora, PhD, MBA
Sr. Vice President,  FirstMark

Robert Wilensky, MD
Professor of Medicine at the Hospital of the University of Pennsylvania
Director, Interventional Cardiology Research

Peter Wilson, MD
Professor of Medicine, Emory Clinical Cardiovascular Research Institute
Professor of Public Health at the Rollins School of Public Health
Director of Epidemiology and Genomic Medicine, Atlanta VA Medical Center
Co-Developer and former Director of Laboratories at the Framingham Heart Study, National Heart, Lung, and Blood Institute, Framingham, Mass

For more information about FirstMark PREvent and the Scientific Advisory Board, visit FirstMarkPREvent.com

FirstMark PREvent
PREvent is the first and only multiple biomarker blood test on the market that predicts near term (2-3 years) risk of myocardial infarction (MI) in patients with suspected or confirmed, insignificant or significant coronary artery disease (CAD).  PREvent identifies CAD patients in the top 4% at highest risk, and the next 17% at moderate risk of MI. The data showed an annual average of 16% of CAD patients with all three biomarkers elevated experienced a myocardial infarction or death, compared to only 2% of CAD patients with all biomarkers normal. It also reclassifies 42% of CAD patients from high to low risk, or low to high risk.

About FirstMark
FirstMark is Division of GenWay Biotech. FirstMark is focused on the development and commercialization of non-invasive diagnostic and health monitoring tests for unmet clinical needs. Headquarters are located in the heart of San Diego’s biotech community in the Sorrento Valley/Mesa area.

Dr. Sergey Sikora, Sr. Vice President of FirstMark, will present the research and data at the Symposium at 12:00 p.m. – 1:00  p.m., Sunday, June 24th, Paradise Point Resort at Mission Bay, Garden Room. Dr. Sikora is co-creator of a PREvent, along with noted cardiologists and researchers Dr. Arshed Quyyumi at Emory University, and Dr. Stephen Epstein at MedStar Health Research Institute. FirstMark will be exhibiting at the symposium on Friday, June 22nd, and Saturday, June 23rd.

“We look forward to the opportunity to present to the family physicians in attendance at the symposium,” said Dr. Sikora. “The symposium focuses on novel technologies that determine patients at risk for particular medical conditions, in order to control or prevent further complications. This event provides a perfect setting for FirstMark to share the remarkable research data and benefits of PREvent. We believe many of the physicians that are in attendance will find PREvent of interest with strong potential for clinical application for their CAD patients.”

PREvent provides superior cardiac risk information by identifying the top 5% of CAD at the highest risk of MI with a hazard ratio of 5.5. The data showed an annualized event rate of MI or death for 18.2% of significant CAD patients with all three biomarkers elevated as compared to only 2.45% of significant CAD patients with all biomarkers normal. The multiple biomarker model adds markedly to traditional risk-prediction by significantly improving C-statistics from 0.695 for base model to 0.750, distinguishing high risk from low risk patients.

About FirstMark
FirstMark is a division of GenWay Biotech, Inc. The FirstMark division is focused on the development and commercialization of non-invasive diagnostic and health monitoring tests for unmet clinical needs. Headquarters are located in the heart of San Diego’s biotech community in the Sorrento Valley/Mesa area. For additional information please visit FirstMarkPREvent.com.

SAN DIEGO, California – June 13, 2012 – FirstMark, the diagnostic division of GenWay Biotech, announced today that Dr. Prediman K. (PK) Shah has joined its Scientific Advisory Board.

Dr. Shah is Professor at Cedars-Sinai Professorial Series and Director of the Division of Cardiology. He also is the Director of the Oppenheimer Atherosclerosis Research Center at Cedars-Sinai Medical Center where he leads several studies that focus on heart disease prevention and treatment. Dr. Shah holds the Shapell and Webb Family Chair in Clinical Cardiology at Cedars-Sinai. Dr. Shah has been Professor of Medicine at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) since 1992. Between 1992 and 2005, Dr. Shah and his colleagues conducted revolutionary research on mutant apo-A1 protein, called Apo-A1 Milano that produced a form of HDL that provided greater protection against atherosclerosis and vascular inflammation. In separate studies conducted, Dr. Shah found that a vaccine created from LDL significantly reduced plaque buildup in animals that had high cholesterol levels.

“We are very pleased Dr. Shah has joined FirstMark’s advisory team“, said Thomas Silberg, President and CEO of GenWay Biotech. “His outstanding background in cardiovascular medicine, focus on prevention, and extensive experience in research will be a critical support as we continue to build clinical interest and application for FirstMark PREvent.”

Dr. Shah joins the FirstMark Scientific Advisory Board that is composed of innovative and nationally recognized leaders in cardiology and research. Each of these individuals has made substantial contributions to the field of cardiology. The main focus of the Board is to provide guidance for further clinical development and validation of FirstMark’s new cardiovascular test PREvent. PREvent is the first and only multiple biomarker blood test on the market that predicts near term (2-3 years) risk of myocardial infarction in patients with suspected or confirmed, insignificant or significant coronary artery disease. The test was recently launched, and its remarkable data is receiving a strong reception throughout cardiovascular medicine.

The FirstMark Scientific Advisory Board is comprised of prominent cardiologist and research scientists including:

George A. Beller, MD, MACC
Cardiologist, University of Virginia Health System
Past President of the American College of Cardiology
Past President of the Association of University Cardiologists
Past President of the Association of Professors of Cardiology

Stephen Epstein, MD
Executive Director of the Cardiovascular Research Institute (CRI), MedStar Health Research Institute
Clinical Professor of Medicine at the Georgetown University School of Medicine
Former Chief of the Cardiology Branch of the NHLBI at the National Institutes of Health in Bethesda, MD

Arshed Quyyumi, MD, FACC, FRCP
Tenured Professor of Medicine, Division of Cardiology, Emory University School of Medicine,
Co-Director, Emory Clinical Cardiovascular Research Institute

Prediman K. Shah, MD, FACC, FACP, FCCP
Director, Division of Cardiology at Cedars-Sinai Medical Center
Director, Oppenheimer Atherosclerosis Research Center at Cedars-Sinai Medical Center
Shapell and Webb Family Chair in Clinical Cardiology
Professor, Cedars-Sinai Professorial Series

Sergey Sikora, PhD, MBA
Sr. Vice President,  FirstMark

Robert Wilensky, MD
Professor of Medicine at the Hospital of the University of Pennsylvania
Director, Interventional Cardiology Research

Peter Wilson, MD
Professor of Medicine, Emory Clinical Cardiovascular Research Institute
Professor of Public Health at the Rollins School of Public Health
Director of Epidemiology and Genomic Medicine, Atlanta VA Medical Center
Co-Developer and former Director of Laboratories at the Framingham Heart Study,
National Heart, Lung, and Blood Institute, Framingham, Mass

For more information about FirstMark PREvent and the Scientific Advisory Board, visit FirstMarkPREvent.com

FirstMark PREvent
The study revealed superior cardiac risk information by identifying the top 5% of CAD at the highest risk of MI with a hazard ratio of 5.5. The data showed an annual average of 18.2% of significant CAD patients with all three biomarkers elevated experienced a myocardial infarction or death, compared to only 2.45% of significant CAD patients with all biomarkers normal. The multiple biomarker model adds markedly to traditional risk-prediction by significantly improving C-statistics from 0.695 for base model to 0.750, distinguishing high risk from low risk subjects.

About FirstMark
FirstMark is a division of GenWay Biotech, Inc. The FirstMark division is focused on the development and commercialization of non-invasive diagnostic and health monitoring tests for unmet clinical needs. Headquarters are located in the heart of San Diego’s biotech community in the Sorrento Valley/Mesa area.

“GenWay leads the industry in product quality and customer satisfaction. We are truly proud of our reputation, and grateful for our customer’s trust and support. Our customer’s success, and contribution to our shareholders return on investment are the driving factors behind GenWay, and we are leveraging this success for our growth plans,” stated Thomas Silberg, President and CEO of GenWay Biotech. “Mark’s dedication to customer satisfaction, and his extensive experience in the biopharmaceutical industry developing and implementing robust manufacturing processes and assays, will be integral to GenWay Biotech’s growth plans. We look forward to having him apply those same skills at GenWay.”

As Vice President of GenWay Custom/OEM division, Fitchmun’s primary role will be to lead the strategic direction for growth and day-to-day activities for the division. Fitchmun’s 25 years of leadership and technical experience in the biopharmaceutical industry has ranged from small entrepreneurial biotech startups, to large established equipment and pharmaceutical companies. Since 1992, Fitchmun served as Principal for Somateck, Inc., where he provided development, manufacturing, and project management support to companies creating next generation biopharmaceuticals, diagnostics, research reagents, and kits for domestic and international clients. He has also held positions at biotech companies such a GenStar Therapeutics, Demos, Hygeia and Bio-Rad.

Fitchmun’s unique qualifications will allow him to direct the expansion of the expertise, knowledge and technologies owned by GenWay, and to drive the development of cutting-edge enabling technologies to deliver faster, more reliable and cost-effective services and products than competitors.  “GenWay is in an excellent position to grow the Custom/OEM division. Our talented team of scientists and technicians provide the utmost quality for custom reagent development, assay development and qualification for our clients in the pharmaceutical and diagnostics industry, “ said Fitchmun. “I look forward to leading this impressive team, winning new contracts, and maintaining the highest level of service to enable the productivity of GenWay’s clients.”  

FirstMark will showcase its new cardiovascular test PREvent at the meeting. PREvent is the first and only multiple biomarker blood test on the market that predicts near term (2-3 years) risk of myocardial infarction in patients with suspected or confirmed, insignificant or significant stable CAD. The test is an exciting development in cardiovascular medicine, providing a simple solution for the huge unmet need of assessing CAD patients risk of near term myocardial infarction.

“One of the goals of the inaugural Atlanta CCU meeting is to give attendees the opportunity to catch up on recent clinical trials that are likely to influence practice, presented at conferences such as the American Heart Association and American College of Cardiology Scientific Sessions. The clinical trial for PREvent, was conducted at Emory University and presented at both of these conferences in oral Poster Presentations,” said Thomas Silberg, President and CEO of GenWay Biotech. “The final data is quite remarkable, and we are excited for the opportunity to once again highlight the study and present the test.”

About PREvent
PREvent provides superior cardiac risk information by identifying the top 5% of CAD at the highest risk of MI with a hazard ratio of 5.5. The data showed an annual average of 18.2% of significant CAD patients with all three biomarkers elevated experienced a myocardial infarction or death, compared to only 2.45% of significant CAD patients with all biomarkers normal. The multiple biomarker model adds markedly to traditional risk-prediction by significantly improving C-statistics from 0.695 for base model to 0.750, distinguishing high risk from low risk subjects.

For additional information, please visit FirstMarkPREvent.com.

About FirstMark
FirstMark is a division of GenWay Biotech, Inc. The FirstMark division is focused on the development
and commercialization of non-invasive diagnostic and health monitoring tests for unmet clinical needs. Headquarters are located in the heart of San Diego’s biotech community in the Sorrento Valley/Mesa area.

“Heart disease is the number one cause of death in the U.S. There is a pervasive need for PREvent to identify patients at risk in the Southeast region of the country. I am confident that Jay will help infuse FirstMark with strong, disciplined professional sales management to support our corporate growth initiatives for PREvent, while building and fostering strong relationships with physicians in this territory,” said Thomas Silberg, President and CEO of GenWay Biotech.

Houtman brings a unique depth of experience in sales, customer service, training and technical expertise in cardiovascular and oncology, diagnostic and pharmaceutical solutions. Previous experience includes sales management positions with Bristol-Myers Squibb, Sanofi-Aventis and Gambro. He has consistently ranked with these companies as first in the nation and various regions for sales performance and customer service. Houtman received his B.S. in Health Sciences from the University of Oklahoma.

“The opportunity with FirstMark is phenomenal,” said Houtman. “It isn’t often that a novel test like this comes along that is so rich in data and supported by leading cardiologists. I am thrilled to have the opportunity to represent PREvent and its potential to save lives from heart attacks.”

About PREvent
PREvent is the first and only multiple biomarker blood test on the market that accurately predicts the risk of near term (2-3 years) myocardial infarction or death in patients with suspected or confirmed, insignificant or significant coronary artery disease. Research has discovered that there are multiple pathways that lead to formation of vulnerable plaques. PREvent aggregates three cardiovascular biomarkers that identify these pathways, and projects the propensity for an individual to develop vulnerable plaque. PREvent provides physician’s diagnostic clarity in identifying CAD patients that are in most urgent need of aggressive treatment, compliance and monitoring.

About FirstMark
FirstMark is a division of GenWay Biotech, Inc. The FirstMark division is focused on the development and commercialization of non-invasive diagnostic and health monitoring tests for unmet clinical needs. Headquarters are located in the heart of San Diego’s biotech community in the Sorrento Valley/Mesa area. For additional information please visit FirstMarkPREvent.com.