Gamma Medica presented clinical evidence confirming that adding its LumaGEM Molecular Breast Imaging system to mammography as a secondary screening method is more than twice as effective as mammogram plus ultrasound in detecting breast cancer in women with dense breast tissue.
The presentation was made at this year’s Radiological Society of North America 102nd annual meeting (RSNA 2016) Nov. 27 to Dec 2 in Chicago.
The clinical results presented at the meeting were published in the American Journal of Roentgenology under the title “Supplemental Breast Cancer Screening With Molecular Breast Imaging for Women With Dense Breast Tissue.”
This study featured LumaGEM to prove the benefits of molecular breast imaging (MBI) versus mammograms for dense breast tissue in women, which includes about half of the women in the U.S.
Breast cancer diagnosis is not perfect. Dense breast tissue and cancer both appear white on mammograms, sometimes making it difficult to distinguish between the two. As a result, some women with dense breast tissue receive a negative mammogram result when they do have breast cancer.
LumaGEM’s MBI technology is an imaging modality that improves early and accurate breast cancer detection for these women, with recent studies confirming that MBI highlights metabolic activity in breast tumors not visible on mammograms due to tissue density, leading to earlier diagnosis.
Clinical studies have also demonstrated that LumaGEM can potentially reduce the need for biopsies by 50 percent when compared to other methods. Biopsies are often painful and costly.
A retrospective study of more than 1,700 women with dense breast tissue over the course of three years showed LumaGEM MBI was shown to enhance the cancer detection rate by 7.7 cancers per thousand compared to primary mammography screening alone (three cancers per thousand).
That study found that MBI, used as a secondary screening method, could increase the number of cancers found to approximately 12 per thousand. In addition, 85 percent of these cancers were confirmed as invasive and node negative, indicating they were detected at an early stage when prognosis is better.
Over the past year, more health systems have started using Gamma Medica’s MBI system. The company launched its Be Certain campaign to educate women about dense breast tissue, and to offer accurate information on secondary screening and breast cancer detection.
“This year’s clinical reinforcement combined with our partnerships with major health systems and expanding share of voice collectively underscore how we are spreading critically needed awareness not just about breast density in general, but about LumaGEM MBI,” Philip Croxford, president and CEO of Gamma Medica, said in a press release.