At a Glance
Investors: Atossa Genetics at a Glance
Business Description: The Pap Smear for Breast Cancer
Atossa Genetics, Inc. (Atossa) is engaged in the commercialization of an FDA-cleared device for breast cancer. The FDA has indicated that the device can be used with cytology to differentiate normal versus premalignant versus malignant changes. Atossa launched the product in December 2011.
The company was founded in 2009 by Steven Quay, MD, PhD, who holds 75 US patents, has invented five FDA-approved drugs, and has started and/or managed five companies. He was formerly on the faculty of the Stanford University School of Medicine and received training at the University of Michigan, MIT, and Harvard Medical School.
Atossa has received FDA clearance to market the Mammary Aspirate Specimen Cytology Test System (MASCT System), a medical device (below, left) which is designed to be used with the the ForeCYTE Breast Health Test to collect a small amount Nipple Aspirate Fluid (NAF) (below, right) for diagnostic purposes. Performing the test takes ten minutes, uses no radiation, and is painless.
Atossa Genetics performs all testing of ForeCYTE Breast Health Test NAF samples in its CLIA-certified clinical laboratory; the National Reference Laboratory for Breast Health.
Technologies / Special Know-how
The device is protected by 14 issued patents worldwide covering the US, Europe, Japan, Australia, Canada, and Hong Kong. Additional applications, including China, India, and Taiwan are pending. Patents protect both the device and the laboratory services.
Second generation diagnostic products and services derive from additional patented technologies in which samples of breast fluid, containing cancer biomarkers and abnormal and malignant cells, are obtained from the breast following administration of oxytocin, a brain hormone involved in lactation that increases NAF production.
All women undergoing mammography, having a cervical Pap Smear, or a general physician visit should receive the test. The potential market is over 35 million women per year in the US and over 100 million worldwide. Outside the US, where mammography is less available, the test may become the primary screening modality.
Product will be initially distributed by a regional direct sales force calling on mammography clinics and Ob/GYN practices. The adoption goal is to have this procedure performed during routine mammography and/or Pap smear tests.
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Corporate: Ropes & Gray LLP
Intellectual Property: Wilson, Sonsini, Goodrich & Rosati LLP