SEATTLE, May 11, 2023 /PRNewswire/ -- Physician-Scientist Dr. Steven Quay, MD, PhD has provided a set of recommendations to the United States Preventive Services Task Force (USPSTF) following the publication of their draft report on breast cancer screening. The draft recommendations were made available for public comment on May 9, 2023 and can be found here: Breast Cancer: Screening. In the draft recommendations, the USPSTF calls for mammograms to begin at 40 years of age, returning to their pre-2009 recommendation. In 2009, in a decision that was met with controversy in the medical community, the USPSTF said that women could wait until they were age 50 before beginning screening for breast cancer. Dr. Quay has spent the last decade conducting research on breast cancer, including its prevention, and has 71 patents and patent applications related to his work.

"I appreciate that the USPSTF has brought their recommendation in line with decades of data and back to their 2009 recommendation of starting at age 40, agreeing with the medical community of the benefits of starting screening early," stated Dr. Quay, MD, Ph.D., President and CEO of Atossa Therapeutics, Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company with a focus on breast cancer. "However, for 14 years women in their forties have been left to fend for themselves. I believe that the shift in recommendation from age 40 to 50 in 2009 may have led to thousands of early breast cancer diagnoses being missed as a consequence. And the toll is heaviest in those women without access to quality healthcare, including women of color."

Dr. Quay's comments to the USPSTF consist of three recommendations:

• Women who are at normal risk of breast cancer should begin mammographic screening at age 40. If they have risk factors that identify them as high risk, using validated risk assessment tools like the "Gail Model," their first mammogram should be at age 35. Breast cancer for women in their 40s has an incidence of 150 to 200 cases per 100,000 population. That translates into 30,000 to 40,000 cancers that were missed with the previous recommendations of beginning at age 50.
  
  Given that the compliance of mammography screening with respect to guidelines is only 75%, the USPSTF should consider recommendations that link government-based healthcare reimbursement to programs and outcomes that lead to improved compliance.
  
  
• High breast density is a known, modifiable risk factor for future breast cancer as well as reducing the sensitivity of mammography for breast cancer detection. The FDA has now required that all mammography reports sent to women beginning in the fall of 2023 contain information about breast density, and its impact on sensitivity and cancer risk.
  
  The USPSTF should consider two density related matters: they should consider recommending additional imaging, either ultrasound or MRI, for women with high breast density; and they should consider providing a report on the strength of the evidence of the relationship of density, mammographic sensitivity to cancer detection, and future cancer risk. This report should also include an analysis of the evidence that certain factors can reduce breast density, including lifestyle changes, diet, and pharmaceutical interventions. For example, clinical trials of the effect of Z-endoxifen on breast density are being conducted by Atossa Therapeutics, Inc. and data will be forthcoming.
  
  
• While the mortality of breast cancer makes it the most frequent cancer-related death in women, cardiovascular disease remains the number one killer of women. Recent developments in the detection of breast artery calcification (BAC) in routine mammograms and its value in predicting women at high risk of cardiovascular disease and its sequelae has been impressive. The USPSTF should consider examining the evidence of the utility of this ancillary data from screening mammograms and determine if recommendations for its use to help stratify women at risk of cardiovascular disease is warranted.

ABOUT STEVEN QUAY, MD, PHD

 Dr. Steven Quay has 390+ published contributions to medicine and has been cited over 11,500 times, placing him in the top 1% of scientists worldwide. He holds 88 US patents and has invented seven FDA-approved pharmaceuticals which have helped over 80 million people. He is the author of the best-selling book on surviving the pandemic, Stay Safe: A Physician's Guide to Survive Coronavirus. He is the CEO of Atossa Therapeutics Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology, including his patented Z-endoxifen for breast cancer and other conditions.

He received his M.D. and Ph.D. from The University of Michigan, was a postdoctoral fellow in the Chemistry Department at MIT with Nobel Laureate H. Gobind Khorana, a resident at the Harvard-MGH Hospital, and spent almost a decade on the faculty of Stanford University School of Medicine. A TEDx talk he delivered on breast cancer prevention has been viewed over 220,000 times. For more information, visit www.DrQuay.com

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