QT IMAGING ANNOUNCES SECOND BLINDED SCREENING TRIAL FINDING NON-INFERIORITY TO MAMMOGRAPHY
QT Imaging meets non-inferiority endpoint for mass detection when compared to conventional full field digital mammography (FFDM)
Novato, CA – July 20, 2022 – QT Imaging, Inc., a medical device company focused on the development and commercialization of novel products for medical imaging, today announced positive data regarding sensitivity and specificity of QT Imaging for mass detection from its second blinded Multi-Reader Multi-Case study. Statistical analysis was performed by Dr. Yulei Jiang, PhD of the University of Chicago Department of Radiology and completed this month.
Twenty-four breast radiologists participated in a study of 177 selected cases (32 normal cases and 147 with ground-truth lesions including cancers and benign masses). The study found that QT Imaging is non-inferior to FFDM in screening for breast cancer (positive call-backs) with -0.05 AUC margin.
“We are encouraged by the long-term and continued high performance of QT imaging, especially in women with dense breasts. Along with our previously published study results showing non-inferiority these trial results will be valuable for our FDA submission later this year for a screening indication in younger women with genetic risk factors and who do not qualify for mammography,” said John Klock MD, CEO and CMO of QT Imaging.
“The findings are extremely exciting and set the stage for young women at high risk for developing breast cancer, who currently do not have a technology available to them for safe screening, to finally have a safe and effective method for breast screening evaluation,” according to Elaine Iuanow, MD a Boston-based Breast Imaging Specialist and President of Interpret4U, Inc., a consultant to QT Imaging.
About Dense Breast Imaging
The mammogram is less sensitive in women with dense breasts. According to the National Cancer Institute and the American Cancer Society, mammography has false negative rates of 15 per 100 women and up to 20%, with rates highest in women with dense breasts. Breast ultrasound is important as an adjunct technology particularly in women with mammographically dense breast tissue, where the lack of contrast between dense breast tissue and breast abnormalities renders the mammogram less accurate.
About QT Imaging, Inc.
QT Imaging is a medical device company committed to bringing novel imaging technologies for breast and body imaging to market. The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. QT’s strategy is predicated upon time- and cost-efficient imaging development, with the goal of delivering safe and effective imaging to patients with the utmost urgency.