GE Healthcare's Flutemetamol 18F is a PET imaging agent in development for the detection of beta-amyloid plaque. Data from studies presented at the meeting not only show that this agent correlates with beta-amyloid through in vivo biopsy using PET technology, but data also shows that it can be measured in patients who do not exhibit symptoms of the disease yet.

"Flutemetamol has completed phase III trials and our filing with the FDA is imminent," says a GE spokesperson.


Study findings presented on a late-stage imaging agent from Piramal Imaging, recently formed through the acquisition of worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG, added to this collection of beta-amyloid biomarker research.

Dr. Ludger Dinkelborg, CEO and co-founder of Piramal, spoke about a phase III trial of his company's leading compound, florbetaben, for beta-amyloid PET imaging on six different regions of the brain. The study is unique, not only because it looks at different regions of the brain, but also because it incorporates MRI screening.

"Because PET doesn't have a high spatial resolution, we combined this study with an MRI," says Dinkelborg.

Regional MRI-PET co-registered data were analyzed by three independent blinded readers.

"We now have data on all the regions of the brain and data on histochemistry showing: is the protein [amyloid] there? How much of the protein is there? And in the six regions are there differences?" says Dinkelborg.

The Siemens solution

Siemens Healthcare announced a first-time integrated amyloid imaging solution for detecting Alzheimer's disease.

"We want to provide it as a package to assist in the evaluation of Alzheimer's and other cognitive decline," says Alexander Zimmermann, vice president of marketing and sales for Siemens molecular imaging division.

PETNET Solutions, a Siemens subsidiary, entered a deal last November with Eli Lilly & Company to manufacture and distribute Amyvid, an amyloid imaging agent approved by the FDA in April. Currently, Siemens PETNET Solutions has nine amyloid imaging manufacturing facilities across the country. Because PET biomarkers have short half-lives, this will expand to 16 more manufacturing centers by the end of year to ensure greater access to the biomarker. To reduce production complexity, Siemens has standardized its equipment across the centers and specially trained its technicians to improve the process.

"You can now say with certainty to a business that it will be there at 9 a.m. Monday morning," says Zimmermann.

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