Siemens applies for FDA approval of amyloid imaging system in U.S.

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Negative amyloid PET study in an elderly patient with cognitive impairment indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of Alzheimer's disease. Image obtained with Siemens Healthcare's Biograph mCT and evaluated with 510(k)-pending syngo.PET Amyloid Plaque software. Source: University of Tennessee
On the heels of the FDA’s approval of Amyvid, Siemens Healthcare has applied for FDA 510(k) approval for syngo.PET Amyloid Plaque neurology quantification software. The software may be paired with Amyvid and Siemens biograph mCT PET/CT to comprise an integrated diagnostic imaging system for the detection of amyloid plaques in the living brain.

On April 7, the FDA approved Eli Lilly and Avid Radiopharmaceutical’s Amyvid (Florbetapir F-18 Injection), a radioactive diagnostic agent indicated for brain imaging of beta amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.

Siemens integrated amyloid imaging system encompasses three elements: the Biograph mCT PET/CT scanner, FDA 510(k)-pending syngo.PET Amyloid Plaque neurology quantification software and the manufacturing and distribution of Amyvid.

PETNET Solutions, Siemens’ network of PET drug manufacturing establishments, has established a manufacturing and distribution agreement with Lilly and will begin supplying Amyvid to imaging centers in limited U.S. markets beginning in June 2012, Siemens said. By the end of 2012, the company anticipates having 25 manufacturing centers and co-located radiopharmacies commercially offering the compound.

According to Siemens, the Biograph mCT offers OptisoHD Detection System, UltraHD•PET and an acquisition matrix of 400 x 400 to enable physicians to visualize different brain matter with a volumetric resolution of 87mm³.

syngo.PET Amyloid Plaque, Siemens’ quantification software, is intended to take a patient’s PET amyloid exam and register it against a reference model of a PET amyloid brain. syngo.PET Amyloid Plaque enables physicians to calculate uptake ratios and compare them with established reference thresholds to reflect pathological levels of amyloid, Siemens said.