Washington: Siemens Healthcare has introduced an integrated diagnostic imaging solution for the detection of amyloid plaques — one of the necessary pathological features of Alzheimer’s disease — in the living brain.
The latest elements of Siemens’ integrated solution comes with the company’s US Food and Drug Administration (FDA) application for its syngo.PET Amyloid Plaque proprietary neurology quantification software, as well as the recent FDA approval of Eli Lilly’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 solution encompasses three elements — the new Biograph mCT PET/CT scanner, FDA’s approval-pending syngo.PET Amyloid Plaque neurology quantification software and the manufacturing and distribution of Amyvid.
As the largest producer and distributor of Amyvid, PETNET Solutions, Siemens’ network of PET drug manufacturing establishments, will begin supplying Amyvid to imaging centres in limited US markets beginning in June 2012.
Complementing the new radioactive diagnostic agent, Siemens pending software could potentially support the quantification of amyloid plaque in the brain.
Combined with the company’s family of high-resolution PET imaging scanners, Siemens has now announced for the first time an integrated diagnostic tool for patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
“Siemens is proud to be the first and only company to implement an integrated solution to support the evaluation of Alzheimer’s disease and other causes of cognitive decline,” said Britta Fuenfstueck, CEO of Molecular Imaging, Siemens Healthcare.
“The combination of reliable manufacturing and distribution of Amyvid with Siemens’ new Biograph mCT PET/CT and our pending syngo.PET Amyloid Plaque neurology quantification software will give physicians in the US additional tools for the evaluation of Alzheimer’s disease and other neurologic conditions,” added Fuenfstueck.
A negative Amyvid scan indicates sparse to no amyloid plaques are currently present, which is inconsistent with a neuropathological diagnosis of Alzheimer’s disease and reduces the likelihood that a patient’s cognitive impairment is due to Alzheimer’s disease.
A positive Amyvid scan indicates moderate to frequent amyloid plaques are present; this amount of amyloid plaque is present in patients with Alzheimer’s disease, but may also be present in patients with other types of neurologic conditions and in older people with normal cognition.
Siemens Healthcare clarified that Amyvid is an adjunct to other diagnostic evaluations. A positive Amyvid scan does not establish a diagnosis of Alzheimer’s disease or other cognitive disorder. Additionally, the safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition, or monitoring responses to therapies.