A Diagnostics & Imaging Week
A consortium of research institutions across Europe is involved with the PredictAD project, a new research collaboration aimed at developing new diagnostic procedures for those with Alzheimer's disease (AD).
There is no single test or biomarker available that can predict whether a particular person will develop AD, and a definitive diagnosis is only possible through postmortem analysis.
PredictAD is an EU-funded project that will study imaging biomarkers such as MRI and PET, electrical brain activity measurement and blood-based markers such as proteomics and metabolomics, then develop methods combining data from the different biomarkers.
The project participants said combining this multisource information "may enable earlier diagnosis of Alzheimer's disease, but may also provide crucial information used for differentiating between various forms of dementia and for assessing disease severity."
It may also allow for improved detection of disease progression and treatment efficacy monitoring.
"The aim of PredictAD project is to develop an objective indicator to diagnose Alzheimer's disease at the earliest stage possible," said Dr. Jyrki Lötjönen of VTT Technical Research Center of Finland, the scientific coordinator of the project.
This may be possible, he said, "by combining data from various data sources of patient monitoring, such as neuropsychological tests, medical imaging, electrical brain activity measurements, and analyzing protein and metabolomics levels of blood samples."
"There is a critical need for effective diagnostic tools to help in the early diagnosis of this debilitating disease," said Dr. Lennart Thurfjell, head of diagnostic software, medical diagnostics, at GE Healthcare (Chalfont St. Giles, UK). "Improving our understanding of the role that different imaging and non-imaging biomarkers play during the disease process is key as we strive to develop new diagnostic solutions for Alzheimer's disease."
At a later stage during this three-year project, a selected biomarker set will be used to develop an efficient and reliable software solution that can be used by a physician to assess the risk, to diagnose and to monitor the progress of AD in real clinical conditions using various patient data. The accuracy, usability and cost-effectiveness of the models and software will be clinically evaluated.
Other PredictAD consortium members include Nextim and the University of Kuopio (both Finland), Imperial College London (UK), Uppsala University (Sweden), the University of Milan (Italy) and Rigshospitalet (Denmark).
New MR scanner to combine diagnosis, treatment
A new, dedicated intra-operative magnetic resonance (MR) scanner enables physicians to carry out image-guided surgery as soon as problems are detected and diagnosed possibly in a single outpatient session, according to participants in the collaboration involved in the scanner's development.
The device will allow breast cancer patients to receive faster treatment, they said.
The new technology is being developed by Specialty Magnetics (London), a wholly owned subsidiary of Specialty Scanners, in collaboration with the Institute of Cancer Research (ICR) and the Science & Technology Facilities Council (STFC).
This is the second MR scanner R&D project in which Specialty Magnetics is collaborating with the ICR and the STFC. The £3.2 million project, which began in April 2008, will receive an investment of £1.6 million from the UK government-sponsored Technology Strategy Board.
With conventional MRI systems, patients have to be removed from the scanner and the results analyzed before any surgical treatment can be conducted. The new MR scanner being developed will allow image-guided surgery to take place in "real time" at the moment the problem is detected and diagnosed.
The participants said the new scanner will provide "an excellent platform for treating tumors using non-invasive or minimally invasive ablation techniques such as focused-ultrasound or cryo-ablation, leading to less trauma, more breast tissue conservation, potentially no hospitalization, and less anxiety and stress to women."
They said the technology will enable the seamless integration of image-guided diagnostic and treatment procedures, potentially shortening the pathway to treatment from several weeks and even months to a single outpatient session.
NeuroLogica's CereTom okayed in S. Korea
NeuroLogica (Danvers, Massachusetts) and its distribution partner, Dong Kang Medical Systems (Seoul, South Korea), said the CereTom scanner has received clearance from the Korean Food and Drug Administration (KFDA) for medical capital device imaging.
The CereTom is a portable, eight-slice CT scanner that acquires 1.25 mm slices per rotation. It is capable of performing NeCT, CT Perfusion, Xenon perfusion and CT angiography. The company said it is optimal for use in the emergency room, intensive care unit and operating room because of its portability and ease of use.
The CereTom is installed in more than 100 medical centers world wide.
"We are [pleased] that the CereTom has cleared Korean FDA," said President/CEO Eric Bailey. "South Korea is one of the most innovative and medically advanced countries in Asia, [and] we are confident that the CereTom will improve the standard of care for critically ill patients with neurological emergencies. Our distribution partner, Dong Kang, has an excellent reputation at the best medical institutions in South Korea; we are pleased that they will be representing the CereTom."
Canadian, Mexican approvals for Cepheid
Cepheid (Sunnyvale, California) reported that Health Canada has issued a medical device license for the company's Xpert GBS, for the rapid detection of Group B Streptococcus (GBS), and Xpert EV (enterovirus), for the rapid detection of EV-associated meningitis.
These tests join Xpert MRSA, which received a Health Canada license in January.
Cepheid also has received registration from the Secretary of Health in Mexico for its GeneXpert System and Xpert MRSA, Xpert GBS and Xpert EV tests.
The products will be distributed exclusively through I.L. Diagnostics in Mexico and Fisher Scientific in Canada.
"Regulatory licenses and registrations are critical in our efforts to effectively penetrate these new markets," said Rob Koska, senior VP, worldwide commercial operations. "Both Canada and Mexico will now have access to all of these high medical value-added diagnostic products that are improving patient care throughout the world."
As in the U.S., MRSA is a growing public health concern in Mexico. According to a study published in the Journal of Clinical Microbiology, "The prevalence of resistant bacteria has been increasing rapidly in Mexican hospitals during the last few years. According to different studies performed in the 1980s, 1990s and 2000, the prevalence of MRSA in Mexican hospitals was estimated to vary from 7% to 30%."