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.

The patents are also directed to the following specific biomarkers in NAF: BRCA1 and BRCA2, CA-125, CEA, Ki67 Growth Factor, Cyclin B1, Cyclin D1, Proliferating Cell Nuclear Antigen, Transforming Growth Factor alpha, Tissue Plasminogen Activator, Insulin Growth Factor Receptors, Collagenase Type IV, Laminins, Laminin Receptor, Integrins, p53, rb, nm23, ras, c-myc, c-myb, Heat Shock Proteins, Prolactin, Neuron-Specific Enolase, IR-14, KA 1, KA 14, Alpha-Lactalbumin, Actin, MCA, PSA, Vasopressin, Cathepsin D, PGE2, pS2, IL-10, S-100 protein; Vimentin; Epithelial Membrane Antigen, bcl-2, CA15-3, CA 19-9, Tn Antigen, Alpha-lactalbumin, LASA, Gal-GalNAC, GCDFP-15, Le(y)-Related Carbohydrate Antigen, uPA, uPA related antigens and complexes, uPA Receptor, PAl-1 and PAl-2, Beta-glucuronidase, CD31, CD44 splice variants, blood group antigens including ABH, Lewis, and MN, and genetic lesions or altered expression levels of CCND1, EMS1, and combinations of these markers.

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.