Aug 21, 2012
Siemens syngo.PET Amyloid Plaque software receives FDA clearance
MALVERN, PA, 16 August 2012 – Siemens Healthcare announced today that its syngo®.PET Amyloid Plaque proprietary software¹ has received clearance from the U.S. Food and Drug Administration (FDA) and is now available. Joining the new Biograph mCT™ positron emission tomography/computed tomography (PET•CT) scanner and PETNET Solutions’ PET radiopharmaceutical production expertise, syngo.PET Amyloid Plaque software is the third unique element in Siemens’ comprehensive imaging solution for the visualization and quantification of amyloid plaques – one of the necessary pathological features of Alzheimer’s disease – in the living brain. As the first company to offer a comprehensive amyloid imaging solution, Siemens Healthcare illustrates its innovative power and competitiveness, which are two goals of the company’s two-year global initiative, Agenda 2013.
“Our new syngo.PET software, combined with Siemens’ Biograph mCT PET•CT scanner and expertise in the production of PET radiopharmaceuticals, will provide U.S. physicians with a valuable tool for the evaluation of Alzheimer’s disease and other neurologic conditions,” says Britta Fuenfstueck, CEO of Molecular Imaging, Siemens Healthcare.
syngo.PET Amyloid Plaque software is designed to assist physicians with assessment of beta amyloid uptake ratios in the PET scans of patients being evaluated for Alzheimer’s disease and other causes of cognitive decline. The software registers a patient’s PET amyloid images against a reference model of a PET amyloid brain to better enable the physician to target regions of interest. Siemens’ proprietary affine registration algorithm has been demonstrated in research to have a correlation coefficient of 0.98 to the Fleisher method² – a reference model that identifies six optimal zones to evaluate pathological levels of amyloid plaque burden.³ syngo.PET Amyloid Plaque software enables physicians to quantify uptake ratios (SUVr), which can be compared to Fleisher thresholds. Quantification of amyloid-PET images with SUVr could provide information in patients with possible mild cognitive impairment that is useful in supporting visual reads of amyloid-PET images.
syngo.PET Amyloid Plaque software, the newest component of Siemens’ integrated amyloid imaging solution, is cleared for use with PET and PET•CT equipment.
Siemens’ comprehensive amyloid imaging solution also includes PETNET Solutions Inc., a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., which operates the world’s largest network of PET radiopharmaceutical manufacturing facilities, with over 50 locations worldwide. As part of its best-in-class quality process, PETNET Solutions has highly skilled staff and standardized equipment and processes to ensure that physicians enjoy prompt, consistent access to its PET radiopharmaceuticals.
Additionally, Siemens’ Biograph mCT PET•CT system enables physicians to precisely differentiate between grey and white brain matter with the industry’s finest volumetric resolution⁴ of 87mm³ and four times improvement in contrast (signal to noise) over traditional scanners. With its unique combination of daily calibration and precise anatomical and functional co-registration, Biograph mCT can help make a quantifiable difference in the evaluation of amyloid plaque uptake.
Together, these three elements comprise the industry’s first comprehensive amyloid imaging solution. For more information about this solution, visit: www.siemens.com/alzheimers.
¹ syngo.PET Amyloid Plaque is intended for use only with approved amyloid radiopharmaceuticals in the country of use. Users should review the drug labeling for approved uses.
² Peyrat, J.-M., Joshi, A., Mintun, M., & Declerck, J. "An automatic method for the quantification of uptake with Florbetapir imaging," SNM Publication No.: 210, Reference #: 1311229, www.snm.org/index.cfm?PageID=11533.
³ Fleisher, Adam S., et al: "Using Positron Emission Tomography and Florbetapir F 18 to Image Cortical Amyloid in Patients With Mild Cognitive Impairment or Dementia Due to Alzheimer Disease," Archives of Neurology, July 12, 2011.
⁴ Based on competitive literature available at time of publications. Data on file.
Launched by Siemens Healthcare Sector in November 2011, Agenda 2013 is a two-year global initiative to further strengthen the Healthcare Sector's innovative power and competitiveness. Specific measures will be implemented in four fields of action: Innovation, Competitiveness, Regional Footprint, and People Development.