Atossa Genetics [ATOS] believes it can prevent breast cancer by 2020 -- and in the meantime, capture a unique market opportunity -- with their novel cellular and molecular diagnostic risk assessment products for early detection. Yet in a burgeoning diagnostics space, and rapid advancement in cancer therapeutics, will this company find a niche? The company ran a soft launch for two cleared tests in 2012, and has an additional test ready for initial launch. The national launch for these products is expected in the second half of 2013. This national launch -- coupled with a dedication to developing personalized and preventative medicine -- may yield strong investment opportunity. Atossa's Approach -- A Rundown The Atossa system uses three tests, MASCT, ForeCYTE, and ArgusCYTE to properly assess risk and scope at various stages of detection. "Stratifying all 110 million at risk women is the job of the first test [MASCT]," said Atossa Genetics CEO Steven Quay, MD, Ph.D. in an interview with OneMedPlace. "FullCYTE is for assessing high-risk, and ArgusCYTE for the 2.5 million breast cancer survivors." The majority of breast cancers are initially found in cells that line the inside of the milk ducts in the breast. The changes in these cells (mammary epithelial cells) have been associated with an increased risk of breast cancer. Atossa’s approach is to monitor the changes in these mammary epithelial cells; the company is exclusively focused in the analysis of Nipple Aspirate Fluid (NAF), which carries a rich source of information about an individual women’s breast health. Nipple aspiration uses gentle suction to collect fluid from the nipple. The procedure involves a similar device to breast pumps used by nursing women, and can be obtained from about 75% of women. The NAF collected contains cells from the lining of the milk ducts and lobules. These are the types of cells from which 99% of breast cancers originate. The NAF sample is then sent to the National Reference Laboratory for Breast Health in 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, key indicators for breast cancer detection. In addition, 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. Once the test and analysis is complete, the patients and their doctors will receive a five-page report detailing the findings of the analysis and providing a lifetime risk profile. "Shareholder value is created by providing products and services that satisfy medical need," Dr. Quay said. "Each of our products is addressing an unmet medical need, and we are achieving high-quality revenue in markets that are in billions of dollars." MASCT -- What You Should Already Know Atossa's first FDA-cleared product is the MASCT System: Mammary Aspiration Specimen Cytology Test System. This system is used to collect nipple aspirate fluid for cytological evaluation. The evaluation determines and/or differentiates normal cells versus pre-malignant cells versus malignant cells. The entire MASCT system is simple, yet proven to be reliable for NAF collection. The system uses a hydrophilic (water loving) membrane in contact with the nipples to "wick" fluid from the orifice of the ducts via capillary action during the cycles of negative pressure, thereby increasing the frequency of obtaining NAF in women. To date, the MASCT system has been awarded 14 US and international patents for its design and utility. When clinically tested, NAF was successfully collected from 97% of women to be analyzed. The NAF analysis can detect early cellular changes in the ducts, regular assessment and tracking of cellular changes in the milk ducts, where most breast cancer begins. For clinicians, the MASCT System provides a new assessment of breast health, NAF cytology, and molecular diagnostic biomarkers. The routine use of MASCT Systems during annual physical exams such as mammograms increases the range and depth of documentation for breast health. Over extended time periods, this will allow clinicians to observe any changes or trends in the NAF analysis as a form of the earliest detection of breast cancer. ForeCYTE -- Earlier Detection is Key The ForeCYTE Breast Health Test is Atossa's second commercialized product. ForeCYTE is a non-invasive test that can detect breast cancer cells at the earliest stages of disease. The question remains: why is ForeCYTE different, or better than, a typical mammography? The standard mammography can only detect masses at the minimum of 100 million cells. On the other hand, ForeCYTE can detect cancer with as little as 10 abnormal cells -- this will enable intervention at much earlier stages of the disease than detection through mammogram. Further, cells can be analyzed to determine if they are normal, atypical, or malignant (cancerous). By determining the number and type of pre-malignant or atypical cells in a patient's sample, ForeCYTE provides information about the risk of developing cancer in the future. If a woman has atypical findings, she may choose to adjust her lifestyle or consult her physician about additional screenings and potential treatment options. According to a company survey, prior to using ForeCYTE, only 19% of physicians included in a recent survey knew their patient's lifetime risk of breast cancer. After administering ForeCYTE, 99% of physicians surveyed had the information they needed to know their patient's lifetime breast cancer risk. Currently, the ForeCYTE Breast Health Test is the only test available that provides amplitude of critical information on lifetime breast cancer risk. ForeCYTE is intended as a complementary to the mammogram for middle-aged women, and is also intended as a vital tool for women between the ages of 18 to 49, for whom screening mammography is not yet recommended due to age. ArgusCYTE -- An Untapped Market ArgusCYTE, Atossa's third product (initial launch estimated in late 2013), is an early detection system warning patients about the presence of circulating breast cancer tumor cells (CTC) and molecular profiling of treatment target expression in a simple liquid biopsy specimen. Finding breast cancer tumor cells before they metastasize throughout the body affords early treatment options. The ArgusCYTE has the ability to identify CTC at the levels of less than 10cemms/5mL of whole blood. The test can be applied at the time of diagnosis/biopsy or as a form of monitoring throughout therapy. Next Steps Despite the saturation of oncology treatment in the past decade, Atossa Genetics believes it is operating in a unique space. "The competition is very thin," Dr. Quay said. "We are trying to prevent breast cancer by identifying pre-cursors in breast cancer. Everything in the medical community is designed to detect breast cancer. Available technologies are not designed to find pre-cancer lesions because it involves sampling a much smaller cell [segment]." The company's closest competitor thus far has been Myriad Genetics, with a blood cancer test to identify specific mutated genes. Dr. Quay notes this test only covers 10% of all breast cancers, and can overlook cell abnormalities. To date, the company has 178 issued patents with 50 pending in application. Evidence of efficacy is available from data with over 20,000 women, and publications of more than 140 peer-reviewed papers. Atossa's future plans are to combine all these research studies to further their progress and develop molecular diagnostic biomarkers. In the United States, breast cancer has become an epidemic. About 1 in 8 women will develop breast cancer over the course of her lifetime. In 2011, over 230,000 new cases of invasive breast cancer were diagnosed in women in the US, along with over 57,000 new cases of non-invasive breast cancer. A woman's risk of breast cancer approximately doubles if she has a first-degree relative who has been diagnosed with breast cancer, and about 15% of women who with breast cancer have a family member already diagnosed. As one can see, detecting initial symptoms and understanding risk-factors are of paramount importance. So too, is the prevention of cancer from fully developing in high-risk patients. Atossa will next tackle this platform, by developing treatments containing tamoxifen or raloxifene, and exploring diagnostic biomarkers.