GE Healthcare Studies Identify Streamlined Process for Manufacturingof [18F]Flutemetamol

Recent technical research data reported that the GE FASTlab TM synthesizer combined with Solid Phase Extraction (SPE) and the application of chemometric tools showed an increase in reliability of the manufacturing1 and synthesis2 of [18F]Flutemetamol. [18F]Flutemetamol is a GE Healthcare Positron Emission Tomography (PET) investigational imaging agent currently in phase III development being studied for the detection of beta amyloid using PET brain scans.

"These results are very encouraging in relation to the quality and potential availability of [18F]Flutemetamol for investigational studies ," said Jonathan Allis, MI PET Segment Leader, GE Healthcare Medical Diagnostics. "The ability to streamline the manufacturing process may lead to shorter total synthesis times, providing physicians and patients with increased access for clinical trials."

Data highlights from two technical research abstracts to be featured at the 2011 Annual Congress of the European Association of Nuclear Medicine suggest that:

• Use of the automated GE FASTlab TM synthesizer and cassette-based Solid Phase Extraction (SPE) in place of preparative high performance liquid chromatography (HPLC) for purification of [18F]Flutemetamol offers reduction in pre-synthesis preparation time and may reduce the scope of operator error.1
• Combination of applying chemometric tools and the automated GE FASTlab TM synthesizer established a robust process for synthesis of [18F]Flutemetamol.2

"At GE Healthcare, we are fully committed to developing quality diagnostic tools and products that enable physicians to help patients and their families get accurate information as early as possible," said Pascale Witz, CEO, GE Healthcare Medical Diagnostics.

Data from the following pre-clinical and clinical abstracts will also be presented at the Annual Congress in Birmingham:

• Radiosynthesis, Biodistribution and Metabolic Fate of Three PET Agents for Amyloid-? In Rats: [18F]Flutemetamol, Florbetapir F18 (18F-AV-45) and Florbetaben (BAY 94-9172)
• Nuances in [18F]Flutemetamol Reader Methodology: High Inter and Intra Reader Agreement Rates
• White Matter Variability for Two Amyloid Brain PET Tracers: Implications for Partial Volume Correction

[18F]Flutemetamol is one part of a broad portfolio of diagnostic solutions that GE Healthcare is currently developing in the Alzheimer´s field. The company is taking a comprehensive approach to understanding Alzheimer´s disease (AD) through its ongoing research to uncover the causes, risks and physical effects of the disease. GE Healthcare´s global commitment to advance clinical knowledge and provide a variety of technologies to aid the fight in this epidemic may assist physicians in the acceleration of diagnosis and improvement of treatment decisions in all stages of the disease. The company already offers a range of imaging modalities used by physicians to assist in the detection of AD and dementia (CT, MRI, PET, SPECT) and has been a key contributor to the Alzheimer´s Disease Neuroimaging Initiative since its inception. GE Healthcare also plays a key role in PredictAD, an EU-funded research project to develop solutions to enable earlier diagnosis of AD. In addition, GE has formed the Making an Impact on Neurodegenerative Diseases (MIND) Coalition, a multidisciplinary, multi-stakeholder body that aims to fill the gaps in the understanding and management of AD and Parkinson´s disease.

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1 Horn E. Driving increased reliability of PET tracer manufacture using FASTlab and SPE purification. 2011 Annual Congress of the European Association of Nuclear Medicine. Presented on October 19, 2011.

2 Dyrstad K, Powell N, Horn E. Robust yield of [18F]Flutemetamol by chemometric optimisation of the labelling reaction. 2011 Annual Congress of the European Association of Nuclear Medicine. Presented on October 19, 2011.