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header-bottom-l.jpg 28 AUG 12

Dear %%First Name%%

This week the theme again seems to be personalised medicine based on your DNA.

We are entering a bold new period for personalized medicine and molecular IVDs, but there are still some urgent problems in the regulatory and reimbursement policy arena. This recent article in IVD Technology by Bruce Quinn sets out some of the issues particularly in the US but the issues exist here in Australia as well.

Secondly, offering genetic tests directly to consumers is a controversial subject among some pathologists and healthcare ethics experts, who question both the science of these tests and whether consumers will do the right thing with the information. A recent article in Dark Daily discusses the issues surrounding the application by test developer 23 and Me for approval of its DNA based tests.

Finally the issue of gene patents never seems to go away. The US Court of Appeals for the Federal Circuit voted 2-1 recently that isolated human genes can be patented, with Judge Alan Lourie noting that "permitting patents on isolated genes does not pre-empt a law of nature." This FirstWord Medtech article discusses some of the issues

Please let us know if you find this useful or otherwise and certainly if you have items that you think would be interesting them please don’t hesitate to email us (p.harman@ivd.org.au) or send us a message via twitter (@IVDAust)

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Scientists discover possible antibiotics alternative
Melbourne scientists say they have made a major breakthrough in the search for an alternative to antibiotics. Researchers have spent the past six years studying the structure of a viral protein called PlyC, and have discovered the way it kills the bacteria that causes a range of infections including sore throats, pneumonia and streptococcal toxic shock syndrome - a potential major step forward in developing alternatives to antibiotics. ABC News
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Insulin pump use in Australia
Insulin pump use in Australia explores the number, characteristics and experiences of insulin pump users, using information from the National Diabetes Services Scheme and the first national survey of insulin pump users, conducted by the Australian Institute of Health and Welfare.  AIHW
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Proteomics International gets funding for molecular diagnostic test
The Australian government has awarded Proteomics International A$1 million to develop biomarkers for diabetic kidney disease into a companion diagnostic test. The funding from Commercialisation Australia will be used by Proteomics International to further validate its discovered biomarkers by performing additional analysis on patient groups. The work, the company said, should result in a more sensitive and effective molecular diagnostic test that will be able to predict kidney disease and monitor its progression in patients.  GenomeWebNews
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Australian Researchers Launch Melanoma Genome Project
Australian researcher have recently launched a two-year, $5.5million initiative to identify the common genetic mutations that cause melanoma. The Australian Melanoma Genome Project brings together researchers from the Melanoma Institute Australia, the University of Sydney, Westmead Millennium Institute, Royal Prince Alfred Hospital and NSW Health Pathology, and the Queensland Institute of Medical Research to identify new methods of diagnosing and treating melanoma based on the genetic characteristics of individual melanomas. GenomeWeb News

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TGA warns on rapid HIV self testing kits
The TGA says rapid HIV self test kits (link) can be bought online, but the tests are not approved in Australia and users risk false positive or negative results and deprive themselves of counselling provided by healthcare professionals

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Life Technologies Acquires Lung Cancer Test Developer Pinpoint Genomics
Life Technologies has announced that it has acquired Pinpoint Genomics and its early-stage non-small cell lung cancer test designed to help doctors identify early-stage patients at high risk for progression to late-stage disease. Financial terms of the acquisition were not disclosed.
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NASA awards $1.1 million for blood analyzer development
The National Aeronautics and Space Administration has awarded DNA Medicine Institute two contracts worth $1.1 million. The Cambridge, Mass.-based company will use the money to develop its rHEALTH sensor, which can run several tests using a single drop of blood, for future space medicine research and clinical applications. Mass High Tech
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MolecularMD Submits Premarketing Approval Application to the FDA for Its BCR-ABL T315I Mutation Test
MolecularMD Corp. has announced that it has submitted its application for Premarket Approval (PMA) of the MolecularMD BCR-ABL T315I Mutation Test to the U.S. Food and Drug Administration (FDA). This test detects the T315I mutation in BCR-ABL RNA transcripts in blood using Sanger sequencing technology. The test can be used to identify patients with chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL) who have the T315I mutation; the test is intended as a companion diagnostic to ponatinib
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Philosys Anticipates US FDA Approval of Gmate Blood Glucose Monitor
UPhilosys applied for approval from US FDA for its Gmate blood glucose monitoring system in Q4 2011, and now expects approval in the third quarter of 2012. The new Gmate SMART is said to be the smallest blood glucose meter in the world and the only one to work with the headphone connector of the iPhone, iPad and iPod. Qmed
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Roche Diagnostics to Invest $300 Million in Indianapolis to Support Expansion of its Clinical Lab Testing business
Roche Diagnostics is pumping $300 million into its North American headquarters in Indianapolis. At the same time, the Roche research and development campus in Nutley, New Jersey will be closed. Collectively both actions are a sign of the company’s confidence in the growth prospects for clinical laboratory testing, molecular diagnostics, and genetic testing. Dark Daily
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Worldwide IVD Market Will Cross $60 Billion Mark by 2014
A new Renub Research report titled “Global In Vitro Diagnostics (IVD) Market Trends and Future Forecast (2009 - 2014)” examines the commercial prospects for IVD in the worldwide healthcare market and predicts it will hit $60 billion within 2 years. IVD Technology
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Israeli Researchers develop "speedy chip"
Researchers from Tel Aviv University in Israel have developed a nanowire-based device to separate and analyze protein biomarkers in blood samples. As they report in Nano Letters, the filtering, separation, and analysis all occurs on a single chip — and rapidly. The chip is made of two compartments, one that is full of a "forest" of densely packed nanowires coated with protein-specific antibodies and one that contains flat nanowires, also coated with antibodies, that are connected to electrodes. The researchers tested their device on its ability to detect troponin T, which it was able to do sensitively and in less than 10 minutes. Science News
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Cambridge Consultants Develop Concept Eco-friendly Blood Glucose Meter
Cambridge Consultants has developed a concept blood glucose monitor that should be simpler to use, less cumbersome to carry and has a third of the environmental impact of traditional devices. When assessing which parts of traditional devices had the highest environmental impact, the design firm discovered that less than 5% of the environmental impact could be attributed to the monitor itself, while more than 70% was attributed to single-use disposables used over the lifetime of the device. Existing blood glucose monitors require separate lancets, test strips, storage tubs for carrying these items and sharps bins for disposal. This makes them fiddly to use, inconvenient to transport and wasteful, especially if you consider that diabetics may be testing their blood glucose about four times a day. The solution was to create a single consumable cartridge that integrates lancets and teststrips into the monitor itself. Medgadget
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India’s Diabetes Device Market Set to Surge
Manufacturers of devices for diabetes treatment increasingly are turning their attention to emerging economies such as India and China to maintain growth. Huge patient pools combined with comparatively low disease awareness are leading firms such as Roche, Sanofi, Novo Nordisk and Lilly to boost their sales and marketing focus in these countries, according to a new report on the diabetes devices market from GBI Research. India’s diabetes device market is the leader of the pack in terms of percentage growth: it is projected to expand an impressive 10% CAGR between 2011 and 2018, from US$146.5 to US$285.2 million Medtech Insider India
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Bristol-Myers Squibb donates $1.6M to fight diabetes in India
The Bristol-Myers Squibb Foundation (New York) reported $1 .6 million in grants to four healthcare institutions in India that will help improve diabetes education, prevention and care and increase healthcare worker capacity in rural and tribal areas and among the urban poor.The prevalence of diabetes in India has grown roughly four-fold since the early 1970s – from about 2% of the population in 1972 to 8.3% today – due to factors ranging from genetic predisposition to lifestyle and dietary changes.
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IVD Sales Contribute to Strong 2Q Financials, Mindray Reports
AHealthy growth in sales of its IVD products contributed to strong 2Q12 growth, Mindray Medical International Ltd. reports. The Chinese medical device company says net revenues reached $267.8 million in the second quarter, a 23.3% increase over the second quarter of 2011. Reagent revenues represented 34.4% of IVD business during the quarter, compared with 28.4% in 2Q11 and 31.5% in the first quarter of 2012.Mindray’s IVD product revenues contributed 27.6% to total net revenues in the second quarter, the company says. IVD revenues increased 31.1% to $73.9 million from $56.4 million during the same quarter in 2011. Mindray introduced IVD products in the first half of 2012, including a high-speed biochemistry analyzer and an auto hematology analyzer. IVD Technology
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Study Finds Genetic Testing Does Not Lead to Increased Healthcare Use
One concern surrounding increased and widespread genetic testing is that it could lead to increased use of an already strained healthcare system in the US. However, multiplex genetic testing may not lead to increased use of healthcare services, a recent study suggests. GenomeWeb News
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HemoGlobe device offers noninvasive way to test for anemia
OResearchers at Johns Hopkins University have developed HemoGlobe, a device programmed to convert mobile phones into systems that can help diagnose anemia, particularly in developing countries where access to anemia tests is limited. The device has a sensor that, when placed on a patient's fingertip, is able to emit different wavelengths of light to help measure hemoglobin levels beneath the skin. It is designed to send test results to a central server that would create a real-time map of anemia cases, which is expected to aid in improving follow-up care and resource allocation. The Engineer (U.K.)
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Wrapping up Genomics and Privacy
The Presidential Commission for the Study of Bioethical Issues wrapped up its public deliberations on genomics and privacy recently, ending a more than year long examination of the emergence of whole genome sequencing as an addition to clinical care and genetic research. The Commission spent several hours publicly discussing the set of recommendations it intends to deliver to President Obama.
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Jamie Drummond on the Power of Crowdsourcing [VIDEO]
Once again a video from one of my favourite sites; TED. Crowdsourcing has considerable power to decipher biological complexities, such as the structure of neuronal networks and the folding of critical enzymes. Jamie Drummond is co-founder of ONE, an advocacy organization whose goals include fighting the AIDS epidemic in emerging countries. In this TEDGlobal Talk, Drummond displays the potential of crowdsourcing to engender solutions to AIDS, malaria, and vaccine shortages, among other critical medical problems. The talk further makes the case for large data sets as being the key to medical innovation in the future. TED via Medgadget
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Measure and track your heart rate using just your iPhone
Medgadget often feature a lot of really innovative medical devices and technologies, but unfortunately, many of them won’t make it to the market or they’ll cost you your firstborn to purchase. That’s why they think Cardiio, a new iOS app available now for $4.99 is pretty cool. Simply put, Cardiio measures and tracks your heart rate using just your iPhone. You may have seen and even tried out other apps that claim to do the same thing, but Cardiio is the real thing, backed by research at MIT and developed by engineers and scientists at MIT and Harvard. It’s also one of the newest startups supported by healthcare incubator Rock Health. Cardiio works by measuring the amount of light that is reflected off one’s face, which is imperceptible to human eyes, but detectable with a camera. Medgadget
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Bug Bite Relieving Gadget Review: We Can’t Believe This Actually Works!
Do you get eaten alive by mosquitos? Is the itch driving you completely and utterly insane?  So when the folks at Gizmodo heard about this magic wand that supposedly takes the itch away, they had to call it in to make fun of it.

They, uh... they were wrong...... Gizmodo

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Bill Gates Awards Grants for Reinventing the Toilet
According to the Bill and Melinda Gates Foundation, forty percent of people on Earth, or about 2.5 billion people, don’t have a safe and sanitary way of doing their business, so the Reinvent the Toilet Challenge was born. This week, Gates awarded grant prizes to three universities for their innovative WCs. Medgadget
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IVD Australia Networking Meeting- Sydney

NEW DATE!

******Thursday 13 September 2012********

IVD Australia members are invited to join with colleagues, friends, and industry members for canapés and drinks at our networking meeting in August. As well as the opportunity to meet and network with other members there will be two presentations.

IVD Industry Update

IVD Australia CEO Peter Harman will update members about all things IVD including the latest information  from the TGA on transitioning products, the AQIS biological review and IVD Australia Code of Conduct training. 

Remuneration and Job Satisfaction in Health Sector

Specialist recruitment consults Patrick O'Loughlin and Catherine O'Mahony from On Q Recruitment  will present a summary of the findings of their comprehensive Job Satisfaction & Salary Survey 2012 results with respondents emanating from the Life Science, Pharmaceutical and Medical Device sectors.

IVD Australia encourages all members to attend this free event.

When:          3:00pm- 5:00pm Thursday 13 September 2012            

Where:       Siemens Healthcare l  South Steyne Room l  160 Herring Rd North Ryde NSW

Cost:            Free for all IVD Australia members

Flyer:            Click here to download the flyer

Register:       Click here to register

Questions:    info@ivd.org.au


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