Atossa Genetics is passionate about improving breast health and the overall well-being and health of women with whom we are associated with globally.  Our focus has been and will continue to be on maintaining our position through the development of a suite of medical devices, therapeutics and laboratory developed procedures (LDPs) in those areas where we can make a difference in health, education and our community with respect to breast health.

To lead the field in breast health, it is imperative for Atossa Genetics to have a robust product development process that brings innovation through a product development lifecycle that yields useable technology available in a timely fashion.  Atossa utilizes a five phase product development life cycle that is focused on using the most up to date standards and practices.  This product development life cycle is current and compliant with national and international standards for quality, so we can ensure that our devices are safe and effective for commercialization.

Current development activities include the ForeCYTE Breast Aspirator intended for the collection of nipple aspirate fluid (NAF) for cytological testing at a laboratory; FullCYTE intraductal microcatheters for the collection of ductal lavage fluid for cytology and genomic marker analysis in addition to the potential administration of a targeted therapeutic; and various endoscopy tools for potential use by breast surgeons. As part of the product development life cycle, appropriate regulatory clearances will need to be obtained for those markets where we plan to do business globally.

We intend to develop a number of our medical devices and laboratory tests so that they can be used as companions to pharmaceutical therapies.  For example, we plan to develop our patented FullCYTE intra-ductal microcatheters for the potential delivery of a pharmaceutical targeted to a condition called ductal carcinoma in-situ (DCIS).  We also plan to develop our medical devices and laboratory tests as companion diagnostics to pharmaceutical therapies to treat women at high risk of breast cancer and for the treatment of proliferative epithelial disease (PED).  These programs are in the initial development phases and will require appropriate validation and regulatory approvals prior to commercialization in markets where we plan to do business globally.

The laboratory tests will be developed by and offered through our wholly owned subsidiary, the National Reference Laboratory for Breast Health (NRLBH). Laboratory tests currently under development by NRLBH include the following:

Cytology Tests

These are cytological tests to be performed on NAF samples sent to the NRLBH, including NAF samples collected with our devices such as the ForeCYTE Breast Aspirator and ductal lavage samples collected with our FullCYTE microcatheters  As referenced above these products are in early development and will require appropriate regulatory approvals prior to commercialization in markets where we plan to do business globally.

NextCYTE Lymph Node Predictor Test

A test being developed for women newly diagnosed by their physician as having breast cancer that is a qualitative in vitro diagnostic test service, performed in a single laboratory, using the gene expression profile of formalin-fixed, paraffin embedded breast cancer tissue samples to assess a patient’s risk for distant metastasis, chemotherapy response and lymph node involvement. It uses the Affymetrix GeneChip 2.0 and proprietary software to quantify and analyze the tumor genetic transcriptome, which represents genes that are being actively expressed within the tumor.

ArgusCYTE CTC Test

A blood sample test being developed for breast cancer survivors which provides information on the presence of circulating tumor cells.

Therapeutic Program and Companion Diagnostics

We are also developing our patented FullCYTE microcatheters for the delivery of pharmaceutical formulations directly into the milk ducts. We plan to initially target DCIS, a condition diagnosed in more than 65,000 patients each year. By using this localized delivery method, patients are expected to receive high local concentrations of these drugs at the site of the pre-cancerous lesions or DCIS potentially promoting efficacy of the treatment while limiting systemic exposure, which has the potential to lower the overall toxicity of these treatments. We also plan to develop our medical devices and laboratory tests as companion diagnostics to pharmaceutical therapies to treat women at high risk of breast cancer and for the treatment of conditions known as proliferative epithelial disease (PED).

All of these tests as outlined are in their initial development phases and will require appropriate validation and regulatory approvals prior to commercialization in markets where we plan to do business globally.