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Low-cost Australian HIV test to reach 33m people worldwide
A crucial new low-cost blood test for HIV sufferers in developing countries that could help 33 million people worldwide may be available later this year. The simple test developed by researchers at Melbourne's Burnet Institute shows how much damage the HIV virus has done to the immune system and whether lifesaving antiretroviral drugs are required. |
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Prototype device designed for onsite flu diagnosis
Researchers at Brown University and Memorial Hospital have created a biochip that can spot flu symptoms by using magnets to target and isolate the influenza RNA sequence, according to a study funded by the NIH and National Science Foundation. The test can be used primarily for onsite flu, TB and HIV diagnosis, researchers wrote in the Journal of Molecular Diagnostics. Mass High Tech |
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FDA clears CDC assay to detect dengue virus
The US Food and Drug Administration has cleared for marketing a test for dengue virus developed by the US Centers for Disease Control and Prevention. The test is the first FDA-approved molecular test for dengue and uses real-time PCR technology. Called the CDC DENV-1-4 Real Time RT PCR Assay, it can detect dengue within the first seven days after symptoms appear and can detect all four dengue virus types. |
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Qiagen Acquires Intelligent Bio-Systems, Maps Out Sequencing Strategy
Qiagen announced it has acquired next-generation sequencing firm Intelligent Bio-Systems and said that it has launched an initiative aimed at pushing sequencing technologies into the molecular diagnostics and clinical research markets |
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Parkinson's UK Seeks Protein Biomarkers for Diagnosing, Tracking Disease
EThe British non-profit Parkinson's UK plans to provide £750,000 ($1.2 million) for research to find protein biomarkers for diagnosing and measuring the progress of Parkinson's disease. The new grant, which is available to researchers within and outside the UK, will fund a study that uses a proteomics-based approach to identify biomarkers in blood or cerebrospinal fluid, Parkinson's UK said in a funding announcement late last week. |
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HSA Enables Faster and Expedited Access for Lower Risk Medical Devices through Enhancements to its Regulatory Framework
The Health Sciences Authority (HSA) announced today that its regulatory framework will be enhanced for lower risk Class A and B medical devices, to facilitate expedited access and lower regulatory fees for these products. Class A and B devices account for about 70% of all medical device applications received by HSA. Further enhancements are also being planned for the higher risk Class C and D devices. The enhanced regulatory framework seeks to better address the concerns of the medical device industry while ensuring patient safety. |
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India bans serological tests for TB diagnosis
Serological test kits for the diagnosis of tuberculosis (TB) in India have been banned by the Indian health ministry due to inconsistent and inaccurate results that can lead to misdiagnoses, Xinhua. |
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Device to Test HIV Immunity Unveiled
Prospects for the IVD industry in China were discussed in some detail during the 2012 China Medical Device Industry Development and Investment CEO Summit, which was held on June 9, 2012 in Shanghai. IVD Technology |
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Device to Test HIV Immunity
Alere Pima, a portable device that provides an absolute CD4 count in people with HIV within 20 minutes, is now available in Kenya, reported allAfrica.com. The kit, which is manufactured by Alere Healthcare, was launched by researchers from the Kenya Medical Research Institute (Kemri) in Nairobi. Kemri scientist Wafula Kellern said the device will help break the HIV infection cycle earlier. FirstWord Medtech |
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One Size Doesn't Fit All when it comes to your genome
Much of the discussion when it comes to personalized medicine centers on accurately interpreting individual genomes. But the genome is a bit of a moving target — and the evidence for this is written all over the human body. GenomeWeb News |
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The Real Promise of Mobile Health Apps
A recent article in Scientific American started with the following quote - “As a volunteer in a trial of mobile health technology, I can attest that it's incredibly cool to pick up your iPhone, fire up an application to monitor your heart rate and rhythm, and then beam your ECG reading to a cardiologist halfway around the globe. As a physician-scientist, I also know that cool technology is not necessarily synonymous with good science or sound health practices and that therein lies a challenge”.
So what really are the benefits of mobile health apps? Scientific American
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Tea drinkers at greater risk of prostate cancer - well at least the men in Scotland are....
Men who are heavy tea drinkers may be more likely to develop prostate cancer, according to research from scientists at the University of Glasgow. Hospitals and AgedCare News |
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And for all you hopeless romantics out there...
David Attenborough narrating "It's a Wonderful World" in a 2 minute video with stunning images taken from his documentaries - thanks Margret... |
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IVD Australia Conformity Assessment Workshop
Friday, 20 July 2012
This advanced workshop concisely unpacks and explains the information required for CA process for transitioning higher class products.
Presented by Ms Shelley Tang the workshop covers:
- Legislative Background to Conformity Assessment
- TGA expectations and available guidance
- Application process, costs and time frames
- Pre-application meeting with the TGA
- Relationship between IVD classification and CA
- The TGA process
IVD Australia strongly recommends this workshop to all members in the Technical and Regulatory area who are planning to tranistion higher class products.
There are limited postions remaining, so please register now if you would like to attend.
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When:
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Friday 20 July 2012 l 9:30 am- 4:30pm
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Where:
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Beau Monde International
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934 Doncaster Rd, East Doncaster VIC 3109
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Cost:
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Members: $350 incl.GST
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Non Members: $525 incl.GST
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Questions?
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info@ivd.org.au
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Registration
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Click here to register
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