Statement on New Dense Breast Notification Law in North Carolina From Atossa Genetics

Twelfth State to Enact Dense Breast Notification Legislation


SEATTLE, WA--(Marketwired - Jul 29, 2013) - Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, today announces its support for the fact that North Carolina has become the 12th state to pass a dense breast notification law, HB 467, the Breast Density Notification & Awareness bill. The bill was signed by Gov. Pat McRoy on July 23, 2013, and will become effective on January 1, 2014.

Dense breast notification legislation requires that women who are found through mammography to have dense breasts must be notified of this fact. Twelve states including Alabama, California, Connecticut, Hawaii, Maryland, Nevada, New York, North Carolina, Oregon, Tennessee, Texas and Virginia have enacted such legislation. Similar dense breast measures have been introduced or advanced in many other states. At the federal level, the Breast Density and Reporting Act of 2011 (HR 3102) was introduced in the previous Congress in October 2011 by Representative Rosa DeLauro (D-CT) and Representative Steve Israel (D-NY).

"Are You Dense Advocacy, Inc. and its supporters are working tirelessly on behalf of women to advance dense breast legislative initiatives at the state and federal levels," said Dr. Steven Quay, Chairman, CEO & President of Atossa Genetics and inventor of the ForeCYTE Breast Health Test for breast cancer risk assessment. "This latest legislative victory is an important step forward in protecting women's health. The need for dense breast notification laws is strongly supported by data indicating that mammograms have greater difficulty spotting tumors in dense breast tissue and that women with dense breasts are at higher risk for breast cancer. We continue to support Are You Dense Advocacy and its efforts to enact dense breast notification laws in the remaining 38 states and at the national level."

In January 2013, Atossa launched the ForeCYTE Breast Health Test. This test analyzes cells from the linings of the milk ducts and lobules, where approximately 95 percent of breast cancers arise, in order to identify pre-cancerous changes that confer an increased risk of breast cancer. Atossa believes that its test is advantageous for women in general, and particularly for women with dense breasts, since dense breast tissue does not affect ForeCYTE's ability to collect and analyze cells from the breast.

"We believe that women ages 18 to 73, including women with dense breasts, should take the ForeCYTE Breast Health Test in order to gain valuable and potentially life-saving information about their breast health status. By identifying women at high risk for breast cancer through scientific means and intervening with lifestyle changes or therapeutic interventions, we believe the incidence of breast cancer can be significantly reduced, just as cervical cancer rates have fallen dramatically since the introduction of the Pap smear," Dr. Quay added.

A peer-reviewed study of 2,712 women age 25 to 65 years showed a strong association between increased breast density and cytological atypia of nipple aspirate fluid, the specimen collected by the ForeCYTE Test. The authors concluded, "Particularly in premenopausal women, the identification of women at increased risk of breast cancer might be enhanced using nipple aspiration." M M Lee, N L Petrakis, M R Wrensch, et al. "Association of abnormal nipple aspirate cytology and mammographic pattern and density." Cancer Epidemiol Biomarkers Prev 3:33-36.

Are You Dense Advocacy, Inc. is the government relations affiliate of Are You Dense, Inc., an independent, national breast health advocacy organization dedicated to informing the public about dense breast tissue and its significance for the early detection of breast cancer. Are You Dense, Inc. was founded by Nancy M. Capello, Ph.D., who was diagnosed with advanced stage breast cancer in February 2004 after receiving "normal" mammography reports for a decade.

For additional information on breast cancer risk, including the risks associated with dense breasts, please visit the Breast Cancer Overview page on the American Cancer Society's website at http://www.cancer.org/cancer/breastcancer/overviewguide/.

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

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., 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.

Are You Dense, Inc. is not affiliated with Atossa Genetics.

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.

Contact Information:

Contact:

Atossa Genetics, Inc.
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