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New ASCO Clinical Practice Guideline for Breast Cancer Risk Reduction May Be Insufficient for Widespread Reduction, Atossa Genetics Says

Companies mentioned in this article: Atossa Genetics, Inc.

SEATTLE, WA -- (Marketwired) -- 08/05/13 -- Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, said that the new ASCO clinical practice guideline for the use of pharmacologic interventions for breast cancer risk reduction, published on July 8, 2013, by the American Society for Clinical Oncology (ASCO), is an important step forward in the fight to prevent breast cancer. However, Atossa believes that the potentially serious side effects associated with the prophylactic use of tamoxifen, raloxifene, arzoxifene, lasofoxifene, exemestane, or anastrozole, which include endometrial cancer, blood clots, stroke, ovarian cysts and cataracts, must be carefully weighed against the potential benefits and carefully targeted to the high risk patients most likely to benefit.

The new ASCO clinical practice guideline is based on the recommendations of the U.S. Preventative Services Task Force and a systematic review of randomized controlled trials and meta-analyses published from June 2007 through June 2012. The guideline encourages physicians to discuss the option of chemoprevention for women at increased breast cancer risk, defined as individuals with a 5-year projected absolute risk of BC ≥ 1.66% (based on the National Cancer Institute BC Risk Assessment Tool or an equivalent measure) or women diagnosed with lobular carcinoma in situ. The guideline also recommends that physicians discuss the specific risks and benefits associated with each chemopreventive agent with their patients.

Dr. Steven C. Quay, Chairman, President and CEO of Atossa Genetics, commented, "While we agree that the data support the use of chemopreventive agents for the prevention of breast cancer in certain cases, we also believe that a woman at high risk for breast cancer due to family history should have our evidence-based ForeCYTE Breast Health Test before making any treatment decision. The fact is that more than 85 percent of women who develop breast cancer have no family history and therefore family history alone is not a reliable or sufficient indicator of true breast cancer risk. Only cytological examination of cells from the linings of the milk ducts and lobules of the breast can scientifically determine whether a woman needs to be especially concerned about her risk. These specimens can be obtained either by a surgical or core needle biopsy or non-invasively with the ForeCYTE Breast Health Test."

Atossa's ForeCYTE Breast Health Test is a non-invasive, quick and painless procedure performed in a doctor's office by a nurse or physician's assistant. The test collects samples of Nipple Aspirate Fluid from the patient's breasts that contain cells from the milk ducts and lobules and then the samples are sent to Atossa's National Reference Laboratory for Breast Health for cytological examination. A patient-friendly report with results and treatment recommendations is then generated for the doctor and patient.

The analysis of those duct cells, from which approximately 95 percent of cancers develop, can show that a woman who is deemed to be at high risk because of family history may actually be perfectly healthy, and thus does not require preventive drug treatment or other interventions. Alternatively, the analysis in a woman with no family history may detect pre-cancerous changes -- up to eight years before a tumor is large enough to be spotted on a mammogram. By more effectively determining a woman's true risk for breast cancer, more informed treatment decisions can be made.

"In addition to considering women thought to be at high risk for breast cancer, I believe in the use of Atossa's evidence-based ForeCYTE test to more accurately assess a woman's breast health status and breast cancer risk for those women thought to be at low risk. By identifying a woman's real risk, we will ensure that women who can truly benefit from treatment with chemotherapeutic agents will get treated, while women at normal risk can be spared from the potential side effects," said Dr. Jonathan Herman of Elite Women's Healthcare, based in Lake Success, New York.

"I have found in my practice that the great majority of the women who have had the ForeCYTE test are pleased with the ease and convenience of the sample collection process and the informative, user-friendly report that is generated. I encourage all physicians to utilize the ForeCYTE test in their practices for the benefit of their female patients," Dr. Herman concluded.

About the ForeCYTE Breast Health Test

The ForeCYTE Breast Health Test, intended for the 110 million women in the U.S. ages 18 to 73, is a painless, quick and non-invasive procedure that can be done in a physician's office. A small sample of fluid, aspirated from the nipple of each breast with the Company's modified breast pump, can provide vital early detection of cancer or pre-cancerous conditions that may progress to cancer over an approximately eight year period and before cancer can be detected by mammography or other means and without the risks of radiation, especially in women younger than age 50. No invasive biopsy needles or open surgical incisions are used in the Atossa test and the test is painless.

Just as the Pap smear has reduced cervical cancer rates by over 70 percent, becoming the most successful screening test in medicine, the goal of Atossa Genetics is to reduce the stubbornly high rate of breast cancer through the early detection of the precursor changes that can lead to breast cancer and the treatment of those early changes.

About Atossa Genetics, Inc.

Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, based in Seattle, WA, is focused on preventing breast cancer through the commercialization of patented, FDA-designated Class II diagnostic medical devices and, through its wholly-owned subsidiary, the National Reference Laboratory for Breast Health, Inc. (NRLBH), patented, laboratory developed tests (LDT) that can detect precursors to breast cancer up to eight years before mammography.

The NRLBH is a CLIA-certified high-complexity molecular diagnostic laboratory located in Seattle, Washington.

For additional information on Atossa, please visit www.atossagenetics.com. For additional information on the ForeCYTE test and the National Reference Laboratory for Breast Health, please visit www.nrlbh.com.

Forward-Looking Statements

Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions by the FDA, regulatory clearances, responses to regulatory matters, Atossa's ability to continue to manufacture and sell its products, the efficacy of Atossa's products and services, the market demand for and acceptance of Atossa's products and services, performance of distributors and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its registration statement on Form S-1 filed April 5, 2013, and periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

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