The Saudi Food and Drug Authority recently issued a Medical Device Marketing Authorization for the LumaGEM breast imaging product by Gamma Medica Inc.
This allows LumaGEM molecular breast imaging (MBI) technology to address not only a large, unmet clinical need in cancer detection in women with dense breast tissue, but also the limitations of anatomical imaging modalities commonly used in breast imaging.
“The approval allows us to sell actively our technology in a rapidly evolving health care environment,” Gamma Medica President and CEO Philip Croxford told Gulf News Journal. “According to the King Faisal Specialist Hospital and Research Center in Riyadh, breast cancer represents 24 percent of all cancer cases, making it the most common form of cancer in women in KSA (Kingdom of Saudi Arabia). This authorization will enable patients in KSA to have the capabilities of molecular breast imaging as a functional imaging modality which highlights metabolic activity in breast tumors that are not visible on mammography due to tissue density. LumaGEM will help in earlier diagnosis, improved outcomes and lowered costs.”
Unlike mammography, tomosynthesis and ultrasound, all of which are anatomical imaging tests, MBI highlights metabolic activity in the breast regardless of tissue density. MBI is a nuclear medicine procedure whereby a radiotracer is injected into the patient a few minutes before imaging. The tracer has a higher rate of uptake in cancerous lesions due to mitochondrial activity in the cells, which shows up clearly on the image as a "hot spot."
“The LumaGEM technology is the first commercially available, FDA-cleared, fully solid-state digital imaging system utilizing dual-head Digital Direct Conversion Gamma Imaging technology for molecular breast imaging,” Croxford said. “With our proprietary design of the cadmium zinc telluride based digital gamma detectors, collimators and application specific integrated circuit electronics, we represent a significant leap forward in technology and performance, allowing breast imaging centers the ability to find smaller cancers, which are non-invasive in women with dense breast tissue.”
Gamma Medica is partnering with Riyadh-based Integrated Business Ventures (IBV) Co. Ltd. to market and supply LumaGEM in Saudi Arabia. IBV is a diversified company in the field of health care disease prevention by providing and selling medical devices to customers across Saudi Arabia.
“Our business strategy is to offer the KSA a near 400 percent increase in detecting invasive breast cancers in 50 percent of women who have dense breast tissue with MBI,” Croxford said. “IBV’s sales channel will be focusing solely with hospitals, medical cities, ministries and disease prevention clinics. With MBI, Integrated Business Ventures now provides the KSA the ability to improve clinical and health economics outcomes.”
In terms of impact for the patient, the LumaGEM MBI will make for an effective tool in cancer detection while keeping the patient in mind. A LumaGEM MBI exam is an easy, safe and comfortable experience for the patient. Although MBI looks like a mammography system in terms of patient positioning, the amount of compression involved is significantly less than mammography – enough to stabilize (not flatten) the breast.“An MBI test involves four different images with capture time ranging from 6-10 minutes per view,” Croxford said. “With LumaGEM’s open view gantry design, patients can watch television or a tablet for entertainment during the exam while image capture is being performed. Women strongly prefer the experience of an MBI over MRI ( Magnetic resonance imaging).”