- Breast Density and Mammography Reporting Act of 2017 -
SEATTLE, Nov. 06, 2017 (GLOBE NEWSWIRE) -- Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today announced its support of proposed federal legislation that, if enacted, will require that mammography reports provided to patients and physicians include information about breast density.
The legislation was introduced on October 25, 2017 in both the House (H.R. 4122) by Representative Rosa L. DeLauro (D-Conn) and in the Senate (S. 2006) by Senator Dianne Feinstein (D-Cal). The parallel bills mandate that mammography reports provided to patients and physicians include a summary that (i) includes information about breast density; (ii) conveys information about the effect of breast density in masking the presence of breast cancer on mammography; and (iii) communicates that individuals with dense breasts should talk with their health care providers about the summary and the potential benefit of additional testing. Additionally, the bills require that the Department of Health and Human Services expand and intensify programs and activities for research relating to breast density. The bills have been referred to the House Committee on Health and Commerce and the Senate Committee on Energy and the Senate Committee on Health, Education, Labor and Pensions.
President and CEO of Atossa Genetics, Dr. Steven Quay, commented, “The presence of dense breast tissue can make it more difficult to evaluate the results of a mammogram because dense breast tissue is comprised of less fat and more stromal tissue which appears white on a mammogram. Cancer also appears white and tumors are therefore often hidden or masked by the dense tissue. Breast density is also associated with an increased risk of breast cancer. Although numerous states have recently enacted laws requiring that patients be notified of breast density, there is no federal standard and approximately 20 states still do not require that information about density be conveyed to the patient. We believe woman have the right to receive this important health information and we applaud the pending federal legislation.”
“In addition, the provisions in the legislation that require expansion of programs and research activities related to breast density should improve diagnosis capabilities and accelerate treatments for this major breast cancer risk factor; which is one of only a few risk factors that can actually be modified,” Dr. Quay added.
Atossa is developing the drug Endoxifen for tamoxifen-refractory breast cancer patients, the treatment of mammographic breast density and other breast conditions. Atossa’s proprietary Endoxifen is being developed as an oral form as well as a topical solution, like a lotion, that can be applied directly to the breast. Atossa recently completed a Phase 1 study of its oral and topical Endoxifen and reported that all objectives of that study were successfully met. A Phase 2 study will be conducted at Stockholm South General Hospital in Sweden and will be led by principal investigator Dr. Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.
Approximately 10 million women have high breast density in the United States and there is currently no FDA-approved treatment for this condition. For more information about breast density please visit www.areyoudense.org.
About Atossa Genetics
Atossa Genetics Inc., is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. For more information, please visit www.atossagenetics.com.
Forward-looking statements in this press release, which Atossa undertakes no obligation to update, 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 and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa, lower than anticipated rate of patient enrollment, results of clinical studies, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others, such as patent rights, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.
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