FDA Grants QT Ultrasound® Breakthrough Device Designation
The FDA has designated the QT Ultrasound Breast Scanner as meeting an unmet medical need for screening women at high risk for breast cancer
Novato, CA – October 31, 2018 – Today the Food and Drug Administration (FDA) granted QT Ultrasound LLC’s Breakthrough Device designation request for its QT Scanner 2000 Model A. Unlike traditional breast imaging modalities, the company’s QTscan™ has no radiation, no injections, and no compression, potentially offering new opportunities for earlier and more frequent screening for young women at high risk for breast cancer who have no available FDA-cleared screening options.
Women at high risk have a 20% lifetime risk of developing breast cancer.1 Causes include genetic factors, family history, and exposure to radiation. With one first-degree female relative, such as a mother or sister, diagnosed with breast cancer, a woman’s risk is doubled. Women who carry a mutation in their BRCA 1 or BRCA 2 genes have a 40-85% lifetime risk of developing breast cancer and are more likely to develop breast cancer at a younger age. 2 While only about 7% of women with breast cancer are diagnosed before the age of 40 years, the most aggressive form of breast cancer and the worst survival rates occur in younger women.3 However, routine mammograms are not recommended for women under 40 years old. Quantitative Transmission Ultrasound is an emerging trend in ultrasound technology that can see through dense breasts and uses no radiation, giving it the potential to have significant benefits for younger women at high risk. “Breast cancer screening is important for all women, but women who are at a higher risk of breast cancer may need to be screened earlier and more often than other women. We hope to provide an imaging option that is safe, comfortable, and effective.” Says Dr. John Klock, CEO and Founder of QT Ultrasound.
The proposed indications for use, as designated by the FDA as breakthrough are:
“The QT Ultrasound Breast Scanner is an ultrasonic imaging system that provides reflection-mode and transmission-mode images of a patient’s breast, without emitting ionizing radiation. The device is intended to be used as an initial evaluation method for asymptomatic women identified with above-average risk for developing breast cancer based upon genetic testing and/or other established criteria, who have not reached the age of mammography screening for their risk level in applicable breast cancer screening guidelines. Diagnostic work-up of findings may follow as clinically appropriate. The QT Scanner is not to be used as a replacement for standard screening mammography.”
The company will be working with the FDA to submit an appropriate pre-market submission. If approved, the device may be legally marketed for use as a breast cancer screening device in younger women at high risk for breast cancer.
About QT Ultrasound
QT Ultrasound® is a privately held company engaged in the research, development, and commercialization of an innovative automated breast imaging system producing high-resolution transmission ultrasound images. The company has received FDA clearance for its QTscan™, and the National Institutes of Health (NIH) awarded over $15 million in funding to continue QT Ultrasound research. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe and include ongoing trials at the Marin Breast Health Trial Center in Novato, California. QTscans are now available commercially through the breast imaging centers of QTbreasthealth™.
The QT Ultrasound Breast Scanner is for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.