SEATTLE, WA--(Marketwired - April 23, 2013) - Atossa Genetics, Inc.
), The Breast Health Company™, believes that new recommendations published on April 16 by the U.S. Preventative Services Task Force
(USPSTF), suggesting that healthy women at high risk for breast cancer take tamoxifen or raloxifene to prevent the disease, are a major step forward. Such drug use can significantly reduce the risk of developing breast cancer, the Task Force report said, so doctors should carefully consider this treatment option for their high-risk patients.
"The USPSTF recommendations are a major step forward but are also incomplete," said Dr. Steven Quay, chairman, CEO and president of Atossa Genetics. "The problem is that the recommendations neglect other steps women can take to better understand their risk of cancer and to spot pre-cancerous changes before tumors actually develop."
Dr. Quay continued, "The identification of high-risk women based largely on family history is woefully inadequate as over 85 percent of women will have no family history. New, personalized diagnostic tools exist that can provide a precise determination of a woman's risk -- and also detect pre-cancerous changes early, for those women without a family history."
For example, Quay points to the ForeCYTE Breast Health Test developed by his own company. The test extracts miniscule samples of fluid from the nipple and examines the duct cells from the breast that are contained in the fluid, much like a Pap Smear looks at cervical cells that undergo changes before becoming cancerous.
The analysis of those duct cells, from which 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 doesn't require preventive drug treatment. 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. That pinpoints a woman's exact risk of developing cancer and allows any pre-cancer to be treated with drugs such as tamoxifen or even with a new type of treatment administered just to the breasts through the breast ducts.
"Rather than treat women thought to be at high risk for breast cancer because of family history, we believe that a test like ForeCYTE can identify those who really are at high risk or who already show pre-cancerous changes, and thus more precisely identify the women who will truly benefit from preventive treatments," said Quay. "The test can also ease the worries of those who are thought to be at high risk but whose duct cells are actually normal and healthy. And it will free them from taking a medication they don't need, won't benefit from, and that may have serious side effects needlessly if they take it."
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 patented breast pump, can provide vital early detection of cancer or pre-cancerous conditions that may progress to cancer over an approximately eight-year period before cancer can be detected by mammography or other means. The ForeCYTE test is painless, uses no radiation, no invasive biopsy needles and no surgical incisions.
Samples obtained by the ForeCYTE method are tested at Atossa's wholly owned National Reference Laboratory for Breast Health, a CLIA-certified high-complexity molecular diagnostic laboratory located in Seattle.
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 patented, laboratory developed tests (LDT) that can detect precursors to breast cancer up to eight years before mammography.
In addition to the ForeCYTE Breast Health Test, Atossa markets the ArgusCYTE Breast Health Test, a blood test for recurrence in breast cancer survivors that provides a "liquid biopsy" for circulating cancer cells and a tailored treatment plan for patients and their caregivers.
For additional information, please visit www.atossagenetics.com.
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 marketing plans, 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 January 28, 2013, and periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.