Atossa Genetics Receives Approval to Begin Clinical Study in Israel

Atossa Genetics

, a healthcare company focused on improving breast health through the development of pharmaceuticals to treat breast health conditions and through commercialization of medical devices and laboratory tests, today announced that it has received institutional review board approval in Israel to begin a clinical study evaluating its ForeCYTE breast aspirator device. The study will evaluate Atossa's ForeCYTE breast aspirator in the collection of Nipple Aspirate Fluid (NAF) in women aged 30-55. Enrollment for the study will start in September 2015, and 70 women will be enrolled in three centers in Israel. The study is the first outside the United States to use Atossa's ForeCYTE device; and it's also the first Atossa-sponsored study that will submit a subset of specimens (those from known carriers of the BRCA germline mutation) to contemporary molecular tests in addition to cytology (cellular evaluation of cells for evidence of ductal hyperplasia or atypia). An important objective of the study is to characterize markers that can aid in the prognostication of women who are carriers of a BRCA germline mutation. BRCA carriers are known to have a 60%-80% lifetime risk of developing breast cancer, but, as yet, no markers are known that signal the transition from a healthy breast to a breast at imminent risk of presenting with cancer. Specifically, the study is seeking to obtain data that will help in the development and validation of a molecular marker panel intended to help guide surgeons and women -- particularly the subset of participants who carry the BRCA germline mutation -- in the decision to consider prophylactic bilateral radical mastectomy. Once validated in additional studies, it is believed that the molecular marker panel will ensure that prophylactic mastectomy in this high-risk group of women is never performed too late, never too early, and never unnecessarily, because 20%-40% of BRCA carriers will never develop breast cancer. Additionally, the study is seeking to develop data to support a potential additional CE Mark for the ForeCYTE device in the EU. "We're very pleased that this study can now get underway in Israel," says Dr. Steven Quay, Chairman, CEO & President of Atossa Genetics. "There's lots of potential knowledge to be gained here, and we believe that this will benefit all of our stakeholders, especially women at the highest known risk level for serious breast disease." Additional information about the study can be found at: https://clinicaltrials.gov/ct2/show/NCT02539615?term=atossa&rank=1