We are a healthcare company focused on the development and marketing of novel cellular and molecular diagnostic risk assessment products for breast cancer.
Using our patented, FDA-cleared MASCT System, a nurse or physician’s assistant, can painlessly collect a sample of Nipple Aspirate Fluid (NAF) in about 10 minutes. The MASCT device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Potential $100BN Market for Atossa's Afimoxifene
Only 1% of women with breast cancer choose to take side effect ridden Tamoxifen and the market is $1BN..means if ATOS's Afimoxifene proves safer and effective the 99% will have Afimoxifene as an alternative.
The fact that tamoxifen sold over $1B at its peak despite 99% of its potential client base refusing it, speaks volumes about its sales potential if ever its considerable side effects were removed or mitigated.
That’s where Atossa comes in. Atossa’s gel reformulation of tamoxifen is billed Afimoxifene. While tamoxifen is typically prescribed as a once a day oral pill over the course of 5 years which systemically exposes the body to its effects, the gel formulation Afimoxifene is applied topically to the breast itself, localized to the affected area which the company hopes will reduce the side effect profile. This is what Atossa’s phase 2 trial for Afimoxifene, scheduled to begin in early 2016, aims to find out.
Atossa provides patented diagnostic products and laboratory services for breast cancer risk assessment and prevention
Our products and services address each stage in the breast health care path
- Risk assessment
- Treatment of pre-cancer
- Genetic profiling for cancer recurrence
Commenced commercial launch of Forecyte Test
Pipeline of additional diagnostic products and services
Strong patient demand – Women’s health driven
178 Patents/11 Class II FDA devices
Our products and services address billion-dollar market opportunities
Dr. Steven C. Quay
Chairman of the Board and Chief Executive Officer
Dr. Quay has served as Chief Executive Officer and Chairman of the Board of Directors of the Company since the Company was incorporated in April 2009. Prior to his work at the Company, Dr. Quay served as Chairman of the Board, President and Chief Executive Officer of MDRNA, Inc. from August 2000 to May 2008, and as its Chief Scientific Officer until November 30, 2008 (MDRNA, Inc. was formerly known as Nastech Pharmaceutical Company Inc. and is currently known as Marina Biotech, Inc.). From December 2008 to April 2009, Dr. Quay was involved in acquiring the Company's assets and preparing the Company's business plan. Dr. Quay is certified in Anatomic Pathology with the American Board of Pathology, completed both an internship and residency in anatomic pathology at the Massachusetts General Hospital, a Harvard Medical School teaching hospital, is a former faculty member of the Department of Pathology, Stanford University School of Medicine, and is a named inventor on 14 U.S. and foreign patents covering the MASCT System. He oversaw the clinical testing and regulatory filing of the MASCT device with the FDA that led to its ultimate marketing clearance. Including the patents for the MASCT System, Dr. Quay has a total of 75 U.S. patents, 98 pending patent applications and is a named inventor on patents covering five pharmaceutical products that have been approved by the FDA. Dr. Quay received an M.D. in 1977 and a Ph.D. in 1975 from the University of Michigan Medical School. He also received his B.A. degree in biology, chemistry and mathematics from Western Michigan University in 1971. Dr. Quay is a member of the American Society of Investigative Pathology, the Association of Molecular Pathology, the Society for Laboratory Automation and Screening and the Association of Pathology Informatics.
Dr. Shu-Chih Chen
Chief Scientific Officer
Dr. Chen has served as Chief Scientific Officer and director of the Company since the Company was incorporated in April 2009. Prior to joining the Company, Dr. Chen served as President of Ensisheim beginning in 2008, was founder and President of SC2Q Consulting Company from 2006 to 2008, and served as Head, Cell Biology, Nastech Pharmaceuticals Company, Inc. from 2002 to 2006. During 1995 and 1996, she was an Associate Professor at National Yang Ming University, Taipei, Taiwan, and served as the principal investigator of an NIH RO1 grant studying tumor suppression by gap junction protein connexin 43 at the Department of Molecular Medicine at Northwest Hospital before working in the research department at Nastech Pharmaceutical Company. She is named as an inventor on four patent applications related to cancer therapeutics. Dr. Chen received her Ph.D. degree in microbiology and public health from Michigan State University in 1992 and has published extensively on Molecular Oncology. She received her B.S. degree in medical technology from National Yang Ming University, Taipei, Taiwan in 1984.
Chief Financial Officer, General Counsel and Secretary
Kyle Guse has served as our Chief Financial Officer, General Counsel and Secretary since January 2013. Prior to joining the Company, Mr. Guse practiced law at several of the largest international law firms, including from January 2012 through January 2013 as a partner at Baker Botts LLP. From October 2007 to January 2012 he was a partner at McDermott Will & Emery LLP, and from 1995 to October 2007 he practiced law at Heller Ehrman LLP. Mr. Guse has more than 20 years of experience counseling life sciences and other rapid growth companies through all aspects of finance, corporate governance, securities laws and commercialization. Mr. Guse began his career in 1987 as an accountant at Deloitte & Touche. Mr. Guse earned a B.S. in Business Administration and an M.B.A. from California State University, Sacramento, and a J.D. from Santa Clara University School of Law. Mr. Guse is a licensed Certified Public Accountant and a member of the California State Bar.
Vice President Sales and Marketing
Christopher Destro has served in the role of Vice President of Sales and Marketing for Atossa Genetics since December 2012. Mr Destro has over 16 years of successful sales and client management expertise within the clinical sector of diagnostic biotechnology. From 2007 to 2011, Mr. Destro served in increasingly responsible positions including Vice President of Sales, North America, for three divisions of Magellan Biosciences, where he managed sales of automated blood culture and susceptibility instrumentation for Trek Diagnostics, automated immunochemistry for Dynex and a blood-lead care platform for point of care testing. In July 2011, Magellan was acquired by Thermo Fisher Scientific, where Mr. Destro became a commercial leader of the Microbiology Division, working with national contracts, distribution channels, and direct sales in the clinical, pharmaceutical, and industrial markets. Prior to joining Magellan, Mr. Destro served as Americas Sales Director for International Bioproducts from 2000 to 2007, where he managed sales of core food pathogen diagnostic (ELISA) products while leading 17 distributors for the United States, Canada, Mexico and Latin America. Mr. Destro holds a Bachelor of Science degree in Microbiology from Ohio State University.
Senior VP, Operations
Peter J. Carbonaro has joined the Company as Senior Vice President of Operations. Mr. Carbonaro's primarily focus and responsibilities include regulatory, quality, manufacturing, supply chain, IT, Facilities and Human Resources. A veteran diagnostic/medical device/biotechnology industry decision maker, Mr. Carbonaro brings more than 30 years' experience in process development, supply chain and manufacturing. This includes expertise in product development, technology transfer, manufacturing and supply chain at a number of prominent companies including Gilead Sciences and Hoffmann LaRoche as well as several early stage companies.
Prior to joining Atossa Genetics, Mr. Carbonaro served as Vice President, Operations, at Ondine Biomedical, Inc. from 2011 to 2013. From 2006 to 2011, Mr. Carbonaro served in increasingly responsible positions at Gilead Sciences, Inc., including Director of Manufacturing in Seattle, Washington; Director of Manufacturing in Ireland; Director of Global Operational Excellence, Pharmaceutical Manufacturing and Senior Director, Pharmaceutical Manufacturing. Earlier, Mr. Carbonaro served from 2001 to 2006 as Senior Director of Manufacturing for Corus Pharma, which was acquired by Gilead Sciences in 2006. From 1997 to 2001, Mr. Carbonaro was Vice President of Operations at Bartel, Inc., which was later acquired by Trinity Biotech.
Mr. Carbonaro began his career at Roche Diagnostic Systems, Inc., Belleville, New Jersey, where he served as Production Manager, Senior Group Leader and Associate Scientist. Mr. Carbonaro also served as Vice President of Operations and Director of Operations at Aprogenix, Inc., based in Houston, prior to joining Bartels. Mr. Carbonaro holds an MBA in Organizational Behavior from Iona College and a BS degree in biology from Siena College.
Partners & Resources
Contact Clarity Women’s Health if you want the test
Call customer service at 1 (877) 722-6339
Contact Clarity Women’s Health
To have your healthcare provide place an order
The topics of breast health and conditions of the breast, including cancer, are important for all women, as well as their families, friends, and caregivers. For these reasons and with the advent of the Internet, there are many sources of information for you to learn more about this important health issue. Below are some resources we believe are helpful in raising awareness.
Products and Services
We are a healthcare company and specialized medical device supplier and cytology and molecular diagnostics laboratory, focused exclusively on breast cancer. We will market our MASCT™ System (Mammary Aspirate Specimen Cytology Test) for the collection of Nipple Aspirate Fluid (NAF). The MASCT™ System is a patented, FDA-cleared medical device and it is used in conjunction with the ForeCYTE Breast Health Test™ patient specimen collection kit. The MASCT™ System can be used to collect NAF for cytology testing in the determination and/or differentiation of normal versus premalignant versus malignant cells
The MASCT™ System is marketed towards physicians and clinics that specialize in women’s health, including mammography clinics, dedicated Breast Health Clinics, and Obstetrics/Gynecology medical practices. The collected NAF samples are sent our CLIA-certified laboratory, the National Reference Laboratory for Breast Health.
Because NAF samples are among the smallest medical samples handled by clinical laboratories, specialized procedures, protocols, and equipment will be used to maximize the diagnostic value of each sample. Using both conventional cytology and advanced molecular diagnostic technologies, we intend to deliver accurate and comprehensive diagnostic reports.
The MASCT System
The Mammary Aspiration Specimen Cytology Test System
The MASCT System is FDA cleared for the collection of nipple aspirate fluid for cytological evaluation. The collected fluid can be used in the determination and/or differentiation of normal versus pre-malignant versus malignant cells.
The MASCT System is a simple and reliable method for NAF collection. The MASCT System uses a hydrophilic (“water seeking”) membrane in contact with the nipple to “wick” fluid from the orifice of the ducts by capillary action during the cycles of negative pressure, thereby increasing the frequency of obtaining NAF in women. The MASCT has been awarded 14 US and international patents for aspects of this design.
In clinical testing, NAF samples were collected in 97% of women. NAF analysis is an objective assessment of a patient’s breast health and can detect early cellular changes in the ducts. Regular assessment and tracking of cellular changes in the milk ducts, where most breast cancer begins, enables clinicians and patients to take control of breast health.
The MASCT System provides important benefits to both clinicians and patients.
For clinicians, the MASCT System provides a new assessment of breast health, NAF cytology and molecular diagnostic biomarkers. The routine use of the MASCT System during annual physical exams and mammograms use creates documentation that can be helpful over the years to observe changes and trends. NAF collection is simple, takes about 5-minutes per breast and can be done by a nurse or physician assistant, since it requires no specialized training.
For patients, it is noninvasive, painless, and takes about 10 minutes. It fits easily into the schedule before mammography, the annual Pap smear exams, or during a routine wellness or health checkup.
Important: The MASCT System test cannot exclude breast cancer and is not a substitute for other clinical screening tests, such as mammography and clinical breast exam.
The ForeCYTE Breast Health test
To view the ForeCYTE Training Video click here
The ForeCYTE Breast Health Test is a simple, non-invasive test that can detect breast cancer cells at the earliest stages of disease. For women ages 50 to 73, the ForeCYTE Breast Health Test is intended to be used as a routine screen for breast cancer in addition to an annual mammogram. The test is also intended as an important tool for assessing and maintaining breast health in women between the ages of 18 and 49, for whom screening mammography is not currently recommended.
ForeCYTE versus Mammography
Mammography can only detect masses of at least 100,000,000 cells and do not provide information on the type of cell contained in the mass. In contrast, the ForeCYTE Breast Health Test collects and analyzes individual cells from breast tissue and can determine if they are normal, atypical, or malignant (cancerous). The test can detect cancer when there as few as 10 abnormal cells, enabling intervention at a much earlier stage of disease than was feasible with previous technology.
Predicting Breast Cancer Risk
In addition to detecting cancer cells, the ForeCYTE Breast Health Test also detects atypical (pre-malignant) cells. By determining the number and type of atypical cells in a patient’s sample, the ForeCYTE Breast Health Test provides important information about the risk of developing cancer in the future. A woman who has atypical findings may choose to change her lifestyle or speak with her doctor about alternative breast screening schedules in order to reduce her risk of developing breast cancer or to detect breast cancer as early as possible.
Before the availability of the ForeCYTE Breast Health Test, only 19% of physicians included in a recent survey knew their patient’s lifetime risk of breast cancer. After administering the test, 99% of physicians surveyed had the information they needed to know their patient’s lifetime breast cancer risk. The ForeCYTE Breast Health Test is the only test currently available that provides this critical information on lifetime breast cancer risk. This knowledge empowers women and their doctors to more effectively manage and protect their breast health.
Getting the ForeCYTE Breast Health Test
The ForeCYTE Breast Health Test can be administered in a physician’s office in just a few minutes. Cells and fluid that exist inside the milk duct and lobules of the breast and collected using a small pump that is applied to the outside of the patient’s nipple. This sample, known as nipple aspirate fluid (NAF), contains cells from the lining of the milk ducts and lobules. These are the types of cells from which 99% of all breast cancers originate. The NAF sample is then sent to the National Reference Laboratory for Breast Health at Atossa Genetics for analysis. This analysis uses a patented process to look for the presence or absence of specific proteins that are known to be associated with pre-malignant or malignant cells. This enables detection of breast cancer. Additionally, information on the number of pre-malignant or malignant cells and the amount of specific proteins present on these cells is used to calculate a lifetime breast cancer risk profile. After the test, patients and their doctors receive a five-page report detailing the findings of the analysis and providing a lifetime risk profile.
The Future of NAF Research and Development at Atossa Genetics
The utility of NAF samples in the study of breast cancer prevention, etiology, progression, diagnosis, epidemiology, and therapy monitoring has been demonstrated through studies involving over 20,000 women and the publication of more than 140 peer reviewed papers and studies from multiple laboratories in countries all over the world.
Atossa intends to use this collected knowledge and its own research studies to develop molecular diagnostic biomarkers for breast health and disease. It is hoped that some of these tests will address the growing interest in Personalized Medicine, which PriceWaterHouse has estimated at about $232 billion currently and projects to grow 11% annually, nearly doubling in size by 2015 to over $450 billion.
Atossa has a patent estate that is broad and provides the basis for the Company’s research efforts. Specifically, NAF biomarker issued patents are directed to the general classes of biomarkers, that is, proteins, peptides, glycoproteins, lipids, glycolipids, DNA polynucleotides, or RNA polynucleotides.
Atossa believes that each of the stages of breast cancer, from normal growth, to hyperplasia, to Atypical Ductal Hyperplasia, to carcinoma in situ, and finally to invasive cancer will be associated with specific biomarker patterns. Atossa also believes that conducting genetic sequencing of DNA and RNA from NAF (such as the study of NAF and blood samples from cancer patients where the entire mitochondrial genome was sequenced from both samples and cancer-related mutations in the NAF but not the blood samples was identified) will become routine. Finally, obtaining epigenetic information, for example, by identifying DNA methylation patterns through methylation-specific DNA sequencing, will become the tools for the design of Personalized Medicine therapeutics, including RNAi therapeutics and cancer vaccines.