For more information, visit www.LowDose3D.com
MARLBOROUGH, Mass., August 9, 2016 -- Hologic Inc. (Nasdaq: HOLX) announced today that study results published online in advance of print by Lancet Oncology conclude that Low Dose 3D MAMMOGRAPHY™ exams with C-View™ software are comparable to traditional breast tomosynthesis screening exams in detecting more invasive breast cancers than 2D mammography alone.
While there have been a multitude of studies that have shown that generated 2D images provide equivalent performance to conventional 2D images as part of the tomosynthesis exam, this is the first prospective study publishing final results confirming the benefit each screening modality has on invasive cancer detection rates versus 2D mammography alone.
Hologic’s Low Dose 3D MAMMOGRAPHY™ exam with C-View™ software was created for physicians and patients seeking a low-dose screening option with the same benefits of 3D MAMMOGRAPHY™ exams. With C-View™ software, a 2D image is generated using the tomosynthesis data acquired during the mammography exam, eliminating the need for additional 2D exposures and as a result, decreasing the radiation dose and compression time.
"C-View™ software allows us to lower the patient radiation does of the market-leading Genius™ 3D MAMMOGRAPHY™ exam even further below the established mammography dose guidelines,” said Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions. “We’ve received very positive feedback from customers who have embraced the technology, and this prospective study further confirms that Genius™ 3D MAMMOGRAPHY™ exams maintain the same outstanding performance when coupled with C-View™ software. Beyond that, it's another proof point that tomosynthesis, specifically the Genius™ exam, is the best choice for breast cancer screening."
The population-based screening study, led by Daniela Bernardi, MD, Director of the Mammography Screening Program at the Trentino Health Authority in Trento, Italy, analyzed the results of mammography exams for 9,677 women, all of whom were asymptomatic and over the age of 49. Breast tomosynthesis screening exams with conventional 2D detected 35 percent more cancers and 76 percent more invasive cancers when compared to 2D mammography alone. Furthermore, the combination of breast tomosynthesis with C-View™ 2D images detected 40 percent more cancers overall and 83 percent more invasive cancers than 2D mammography alone.1 Recall positive predictive value (PPV), the probability that patients with positive screening results truly have cancer, was higher for both cohorts compared to 2D mammography alone.1
“We’re very pleased that this prospective study was consistent with previous analyses of the impact of tomosynthesis with synthesized [generated] 2D images on invasive cancer detection rates,” said Dr. Bernardi. “The body of literature as a whole strongly suggests that C-View™ 2D images provide an equivalent contribution as standard 2D mammography, and are an acceptable replacement for traditional 2D exposures as part of a tomosynthesis exam. While some physicians may choose to reduce the number of views to achieve low dose, my colleagues and I view the current lower-dose approach of synthesized 2D images with tomosynthesis more appropriate for breast cancer screening.”
This study was conducted on Hologic’s Selenia® Dimensions® mammography system using the Company’s C-View™ software and as such, the results are not applicable to other manufacturers’ technology.2
Hologic’s Low Dose 3D MAMMOGRAPHY™ exam with C-View™ software is CE marked, FDA approved and is commercially available in the U.S. and Europe. Genius™ 3D MAMMOGRAPHY™ exams are only available on the Hologic Selenia® Dimensions® system. For more information, visit www.LowDose3D.com.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company’s core business units focus on diagnostics, breast health, GYN surgical and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure. For more information on Hologic, visit www.hologic.com.
Hologic, 3D, 3D Mammography, C-View, Dimensions, Genius, Selenia and The Science of Sure are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.
This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic mammography systems and C-View™ software. There can be no assurance the systems will achieve the benefits described here, or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the systems can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that the systems will achieve any expected level of sales or market share. Hologic expressly disclaims any obligation to release publicly any updates to the data or statements presented here to reflect any change in the Company’s expectations or any change in events, conditions or circumstances on which any such data or statements are based.
[i] Bernardi D, Pellegrini M, Valentini M, et al. “Breast cancer screening with tomosynthesis (3D mammography) with acquired or synthetic 2D mammography compared with 2D mammography alone (STORM-2): a population-based prospective study.” The Lancet Oncology. Epub 2016 June 23.
2 Yaffe M. “Reducing Radiation Doses for Breast Tomosynthesis?” The Lancet Oncology. Epub 2016 June 23.