September 30, 2010
Cellestis, stepping up to the plate
From BioTech news,
http://www.biotechnologynews.net/StoryView.asp?StoryID=1539010
OPINION: How we’ve tackled TB
Amanda Ellis
Thursday, 30 September 2010
AUSTRALIAN biotechnology companies navigating commercial success need to remember that no matter how good the technology is, it won’t sell itself, Cellestis managing director Tony Radford has learned.
Dr Tony Radford
When Cellestis first launched its product QuantiFERON-TB Gold, a blood test which can detect tuberculosis (TB) infection, one could be forgiven for believing we had a product that could sell itself.
Our test was proven scientifically to be more accurate than the 100-year-old tuberculin skin test (TST) it was replacing and we could demonstrate that the new test offered economic advantages.
As the test was far more specific and sensitive than TST, it eliminated the huge amounts of time and treatment previously wasted on people who had been falsely diagnosed with TB bacteria, as a result of the old tests.
But although we knew our technology was good, we weren’t naive enough to believe the fax in our Melbourne office would instantly run hot with customers from around the world as soon as QuantiFERON was launched.
We knew from the beginning that the sales process wasn’t as simple as presenting a new test for TB to the customer and getting them to sign on the dotted line.
To gain the most significant market possible we had to be present where the customers and opinion leaders were located.
Therefore, we took the logical step of establishing a sales and distribution network to service our major markets which are the US, Europe, Japan and other parts of Asia.
We found there were several barriers to overcome.
For example, although TB is a highly infectious disease that claims one life every 17 seconds worldwide, the move to modernise TB control has been very slow.
The process is highly regulated and largely controlled by the need for changes to policy guidelines as well as the standard regulatory approvals.
Just this year, the United States Centre for Disease Control (CDC) released its new guidelines recommending the use of IGRAs, simple blood tests known as interferon-gamma release assays (such as QuantiFERON) as the preferred method to test for TB in many circumstances.
The US now joins Japan, Germany, South Korea, the UK, Switzerland and many other countries recognising the benefits of Interferon testing and QFT.
However, obtaining these guidelines was a slow process, with the most recent CDC decisions taking nearly two years to publish.
Rather ironically, Australia has little to no guideline on interferon testing for TB infection, and the federal government facilitates and subsidises the import and use of the TST reagents from overseas to compete with this Australian invention and company.
While TB infection rates are still very high on a global scale, TB tends to be one of those diseases that can be out of sight, out of mind, creating another marketing barrier.
If there is not an immediate threat, there is little need perceived for an organisation to change its testing method.
Becoming cause-related marketers
You simply cannot be involved in TB medicine without realising the burning need to make a difference to what is being done worldwide.
At Cellestis we needed to overcome long-ingrained user habits and navigate through complex public health organisations to get an audience for QuantiFERON.
But we also needed to wage a campaign at a higher level, and help to convince stakeholders from the government down that there is a need to modernise TB control and test for latent infection.
To overcome these challenges Cellestis needed to focus not only on sales but also needed to get behind TB control.
TB is a highly infectious disease and remains a threat to public health.
Although the public perception in developed nations is that TB infection is under control, in fact actual numbers are rising in some countries, and of course in developing nations infection remains endemic and rates of disease high.
Our mission was to raise awareness of the benefit of testing and treating latent TB in developed markets.
Thus we made a commitment to campaign globally with a goal to make latent TB infection diagnosis and treatment the paradigm in all countries – not just the wealthy countries who are trying to keep TB infection rates down, but also in poorer countries where rates of TB infection are high and active TB is a problem.
While this may appear self-serving, given we sell a diagnostic for latent TB, and heretical to some who believe the priority is active TB first, latent TB later, it makes solid health and economic sense.
Current, world TB-control strategies have had only limited success, and it’s clear that killing latent infection before it becomes a serious disease stops further spread – and very economically if a test with high predictive capacity for future TB such as QFT is used.
The outcome of treating latent infection, while good for Cellestis in the process, will also be good for the world and the many millions of people this strategy can save from disease and death.
To support this strategy we have launched campaigns targeting public health organisations, physicians, healthcare workers and administrators, and we have made this goal – treatment of latent infection – our company’s focus.
Given our focus on TB, and our worldwide presence, Cellestis is in a good position to aggregate and disseminate the huge amount of information from scientific journals and conferences and various public health authorities.
As part of this strategy we launched a website TackleTB.com as the centrepiece of our campaign, designed to give clear and simple facts about TB infection and remind our audience why change is needed.
We used triggers such as the release of new CDC guidelines and the publication of a detailed analysis of TB testing in the highly regarded scientific publication CHEST to engage with media, and used an array of channels including video, digital tools and fact sheets to take the message to our audiences.
Has the investment paid off?
The investment in marketing for Cellestis has paid off and will continue to be a vital component of our business.
This year we again achieved strong year-on-year sales growth, with revenues up by 17% in financial year 2010 and expected to continue to grow.
Achieving this growth has required Cellestis to transform from being a research and development company, to a company that has a global sales capability and places great emphasis on marketing.
This has required us to invest in new people and skills, and bring our staff, partners and investors with us on the journey.
For an Australian biotechnology company to tackle a global market and issue of such great proportion, is a solid achievement, particularly when at the time (and arguably still) this was an unusual model for an Australian biotechnology company – given many companies opt to license their technology to a global partner to take it to market.
Shifting the mindset
The need to make these investments and evolve the business is an important lesson to learn as the Australian biotechnology sector matures.
Only a handful of Australian biotechnology companies have so far successfully made the transition from development to manufacturing and independent sales distribution.
Although investing in marketing and acquiring these skills might sound obvious, it requires a significant shift in mindset for a company to transition from focusing on technology development to become a successful sales and marketing company.
Few precedents have been set in the local biotech industry, and it’s my belief there will need to be a period of re-education or realigning investors in the industry to understand that it’s possible to directly chase commercial rather than development success from an Australian base.
We Australians have one inherent advantage in globalisation – we all know our domestic market is insignificant, so we have to look outward and operate globally from day one.
About Tony Radford
Cellestis managing director and chief executive Tony Radford has had a 28-year career in biotechnology, initially as a successful research scientist and as a senior member of the CSIRO team that invented QuantiFERON.
He has held executive roles in the management of commercial research and development in the medical field for the past 15 years and is a founding director of Cellestis.
Radford was head of drug development at AMRAD and has a PhD and undergraduate science degree in microbiology and molecular biology from La Trobe University. B
http://www.biotechnologynews.net/StoryView.asp?StoryID=1539010
OPINION: How we’ve tackled TB
Amanda Ellis
Thursday, 30 September 2010
AUSTRALIAN biotechnology companies navigating commercial success need to remember that no matter how good the technology is, it won’t sell itself, Cellestis managing director Tony Radford has learned.
Dr Tony Radford
When Cellestis first launched its product QuantiFERON-TB Gold, a blood test which can detect tuberculosis (TB) infection, one could be forgiven for believing we had a product that could sell itself.
Our test was proven scientifically to be more accurate than the 100-year-old tuberculin skin test (TST) it was replacing and we could demonstrate that the new test offered economic advantages.
As the test was far more specific and sensitive than TST, it eliminated the huge amounts of time and treatment previously wasted on people who had been falsely diagnosed with TB bacteria, as a result of the old tests.
But although we knew our technology was good, we weren’t naive enough to believe the fax in our Melbourne office would instantly run hot with customers from around the world as soon as QuantiFERON was launched.
We knew from the beginning that the sales process wasn’t as simple as presenting a new test for TB to the customer and getting them to sign on the dotted line.
To gain the most significant market possible we had to be present where the customers and opinion leaders were located.
Therefore, we took the logical step of establishing a sales and distribution network to service our major markets which are the US, Europe, Japan and other parts of Asia.
We found there were several barriers to overcome.
For example, although TB is a highly infectious disease that claims one life every 17 seconds worldwide, the move to modernise TB control has been very slow.
The process is highly regulated and largely controlled by the need for changes to policy guidelines as well as the standard regulatory approvals.
Just this year, the United States Centre for Disease Control (CDC) released its new guidelines recommending the use of IGRAs, simple blood tests known as interferon-gamma release assays (such as QuantiFERON) as the preferred method to test for TB in many circumstances.
The US now joins Japan, Germany, South Korea, the UK, Switzerland and many other countries recognising the benefits of Interferon testing and QFT.
However, obtaining these guidelines was a slow process, with the most recent CDC decisions taking nearly two years to publish.
Rather ironically, Australia has little to no guideline on interferon testing for TB infection, and the federal government facilitates and subsidises the import and use of the TST reagents from overseas to compete with this Australian invention and company.
While TB infection rates are still very high on a global scale, TB tends to be one of those diseases that can be out of sight, out of mind, creating another marketing barrier.
If there is not an immediate threat, there is little need perceived for an organisation to change its testing method.
Becoming cause-related marketers
You simply cannot be involved in TB medicine without realising the burning need to make a difference to what is being done worldwide.
At Cellestis we needed to overcome long-ingrained user habits and navigate through complex public health organisations to get an audience for QuantiFERON.
But we also needed to wage a campaign at a higher level, and help to convince stakeholders from the government down that there is a need to modernise TB control and test for latent infection.
To overcome these challenges Cellestis needed to focus not only on sales but also needed to get behind TB control.
TB is a highly infectious disease and remains a threat to public health.
Although the public perception in developed nations is that TB infection is under control, in fact actual numbers are rising in some countries, and of course in developing nations infection remains endemic and rates of disease high.
Our mission was to raise awareness of the benefit of testing and treating latent TB in developed markets.
Thus we made a commitment to campaign globally with a goal to make latent TB infection diagnosis and treatment the paradigm in all countries – not just the wealthy countries who are trying to keep TB infection rates down, but also in poorer countries where rates of TB infection are high and active TB is a problem.
While this may appear self-serving, given we sell a diagnostic for latent TB, and heretical to some who believe the priority is active TB first, latent TB later, it makes solid health and economic sense.
Current, world TB-control strategies have had only limited success, and it’s clear that killing latent infection before it becomes a serious disease stops further spread – and very economically if a test with high predictive capacity for future TB such as QFT is used.
The outcome of treating latent infection, while good for Cellestis in the process, will also be good for the world and the many millions of people this strategy can save from disease and death.
To support this strategy we have launched campaigns targeting public health organisations, physicians, healthcare workers and administrators, and we have made this goal – treatment of latent infection – our company’s focus.
Given our focus on TB, and our worldwide presence, Cellestis is in a good position to aggregate and disseminate the huge amount of information from scientific journals and conferences and various public health authorities.
As part of this strategy we launched a website TackleTB.com as the centrepiece of our campaign, designed to give clear and simple facts about TB infection and remind our audience why change is needed.
We used triggers such as the release of new CDC guidelines and the publication of a detailed analysis of TB testing in the highly regarded scientific publication CHEST to engage with media, and used an array of channels including video, digital tools and fact sheets to take the message to our audiences.
Has the investment paid off?
The investment in marketing for Cellestis has paid off and will continue to be a vital component of our business.
This year we again achieved strong year-on-year sales growth, with revenues up by 17% in financial year 2010 and expected to continue to grow.
Achieving this growth has required Cellestis to transform from being a research and development company, to a company that has a global sales capability and places great emphasis on marketing.
This has required us to invest in new people and skills, and bring our staff, partners and investors with us on the journey.
For an Australian biotechnology company to tackle a global market and issue of such great proportion, is a solid achievement, particularly when at the time (and arguably still) this was an unusual model for an Australian biotechnology company – given many companies opt to license their technology to a global partner to take it to market.
Shifting the mindset
The need to make these investments and evolve the business is an important lesson to learn as the Australian biotechnology sector matures.
Only a handful of Australian biotechnology companies have so far successfully made the transition from development to manufacturing and independent sales distribution.
Although investing in marketing and acquiring these skills might sound obvious, it requires a significant shift in mindset for a company to transition from focusing on technology development to become a successful sales and marketing company.
Few precedents have been set in the local biotech industry, and it’s my belief there will need to be a period of re-education or realigning investors in the industry to understand that it’s possible to directly chase commercial rather than development success from an Australian base.
We Australians have one inherent advantage in globalisation – we all know our domestic market is insignificant, so we have to look outward and operate globally from day one.
About Tony Radford
Cellestis managing director and chief executive Tony Radford has had a 28-year career in biotechnology, initially as a successful research scientist and as a senior member of the CSIRO team that invented QuantiFERON.
He has held executive roles in the management of commercial research and development in the medical field for the past 15 years and is a founding director of Cellestis.
Radford was head of drug development at AMRAD and has a PhD and undergraduate science degree in microbiology and molecular biology from La Trobe University. B
September 29, 2010
HCWs seen as a global source of TB
What is interesting from this is that
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0030494
Most authors reported that no specific TB infection-control programs were being used in the health-care facilities where the studies were carried out.The emergence of drug resistant TB has focussed minds
Efforts are ongoing to update existing infection-control guidelines in the wake of XDR-TB, and to develop programs that are suitable for resource-limited countries. We strongly support these initiatives and call for more resources and partnerships to tackle the chronically neglected problem of nosocomial TB in low-income countries.
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0030494
Better than a slap in the face with a wet fish?
TBESC notes
Randall Reeves, MD, presented results from the TBESC study titled, “Evaluation of QFT GIT and TST during TB screening of U.S. Visa Applicants in Vietnam.” Data from this study, designed to evaluate QFT vs. TST and determine the ability to follow applicants in the United States, will be relevant to the over 1 million persons screened by panel physicians and civil surgeons each year. Dr. Reves reported that QFT had high sensitivity (89%) when used to screen patients for TB, and that QFT could be used as a “gateway” to prevent excess chest x-rays.
However, he also noted that use of QFT without chest x-ray would result in occasional missed TB cases.
Participants also heard an update on “Evaluation of new IGRAs in the diagnosis of LTBI in health care workers,” presented by Bob Belknap, MD.
They found that only 3% of health care workers with a negative QuantiFERON-TB Gold In-Tube (QFT GIT) test at baseline had a positive QFT at 6 months, whereas almost 53% of persons with a positive QFT at baseline testing had reverted to a negative QFT at 6 months. QFT conversions were more common than tuberculin skin test conversions (0.4%), and weren’t explained by QFT results that were borderline positive.
September 28, 2010
Heads down
Professor John Quiggin writes
A long time ago, I read an article whose author had read through all the leading economics journals from the 1930s. The striking finding was that only a tiny proportion of the articles published in those years concerned the Depression and what to do about it.The Prof reports on the GFC as an issue worthy of study
having attended the Australian Conference of Economists for the last couple of days, I have to say that a future historian of economic thought will be able to rewrite much the same article about the current crisis. Only a handful of papers presented at the conference have dealt with the crisis, even indirectly, and most of those have concluded that we only need marginal adjustments to our current way of doing things.
September 17, 2010
Buffett on the value of navel gazing
Warren Buffett had a Q & A with some kids from from Emory and five other business schools.
On the stock exchange;
On the stock exchange;
Did you hear they called off the Wall Street Christmas Pageant this year? They had trouble finding three wise men…and a virgin. There are many opportunities right now. The markets are very inefficient at times, and this is one of those times.
TB - a real time Lord
Interesting case from a Great Plains Indian reservation;
The first family member to be diagnosed with pulmonary TB disease was its oldest, a 78-year old man who was known to everyone in the town as Roy. He had been ill for several months with a persistent cough, and was treated for respiratory infection over that period of time. Roy had a number of health issues: he was a diabetic; he had a diagnosis of end-stage COPD, leaving him dependent on an oxygen machine; and he was largely confined to a wheelchair. He was also a long-time cigarette smoker, and a heavy drinker. Perhaps all of Roy’s health issues made it difficult for the staff at his local clinic and Indian Health Service (IHS) health center to recognize the signs of TB even as they grew more pronounced over time.Once Roy was finally diagnosed as having TB the focus was on, how did he get it?
The source of Roy’s disease was initially a mystery to me. He had been housebound for some time before feeling ill, and there were no documented cases of TB among the family’s many visitors. After much probing, it eventually emerged that TB in this household had roots in the past. I had spent quite a bit of time talking with Roy and his wife before they remembered that an elderly relative had been very sick with TB in the 1970’s, and had been treated by the Indian Health Service (IHS). I went to the regional IHS facility to look through the old disease registries to find the case. After going through several volumes of charts, I located the case that he told me about. I saw that Roy, his wife, and other family members had been identified as contacts and had been prescribed treatment for latent TB infection. I asked Roy if he remembered being prescribed any medication when their relative was sick. He didn’t remember it, but his wife did. She reminded him that she had completed treatment for LTBI, but that he hadn’t. They joked about him being something of a wanderer in those days. I gathered that they were referring to him being away from the house for periods of days and even weeks, sometimes working and sometimes out with his friends.The use of Quantiferon amongst high risk groups is a strategy recently employed by the New Mexico Department of Health
My research into the case proved worthwhile, because many members of the family were anxious to discover the source of the disease that seemed to spring up among them without warning. Some blamed one member, others another. A brother visiting from California came under particular suspicion, since he had been staying at the house before Roy was hospitalized and the family clamed that brother had a chronic cough. Several family members were insistent that I test him. I shared with them that a TB infection can be latent for many years and can become active and progress to TB disease when a person is immunocompromised. I pointed out that aging, diabetes, a damaged respiratory system, and heavy drinking had left Roy vulnerable to the infection that the body had contained for many years. I assured them that we were working to identify and test all people at risk of infection.
Decrease the number of people unnecessarily started on LTBI treatment due to false positive Tuberculin Skin Testing (TST), by increasing the use of QuantiFERON TB Gold testing in adults age 17 and older, particularly among high-risk populations
September 16, 2010
Time for a Game Change
News that UK scientists devise 'one-hour test' for TB is doing the rounds
As Peter Small and Madhukar Pai a recently noted, better diagnostics makes for a better health business
The new test focuses on a particular DNA region within the bacterium which the researchers says is present in all strains of the disease.Remember, this test is for active TB and could replace the sputum culture test.
Once a sample is taken, a scientific technique know as a "polymerase chain reaction" is used to amplify the volume of DNA available so that the genetic signature can be identified
As Peter Small and Madhukar Pai a recently noted, better diagnostics makes for a better health business
it is clear that improvements in diagnostics are driving a virtuous cycle in care: the promise of improved tests drives their uptake, their uptake results in better health outcomes, improved outcomes attract more funding for health care systems, and better-funded systems are an incentive to the development of even better technologies.
Great Unhinging IV
BHP boss Marius Kloppers calls for a carbon tax
"Carbon emissions need to have a cost impact in order to cause the consumer and companies to change behaviour and favour low-carbon alternatives."and warns the Gillard coalition government to not change the proposed mining tax
"We agreed to something and our intention would be to stick to it."If only the miners could "stick to it"
September 15, 2010
Taking stock
Recently an observer, and probably a holder, made the following comment regarding the Cellestis share price
I'm soooooooo over this stock!This puts me in mind of Alan Stockdale who, as a guest of the infamous 'Hanoi Hilton', suffered torture and deprivation on a scale that is hard to imagine. In his business book Good to Great, James C. Collins writes about a conversation he had with Stockdale regarding his coping strategy during his period in the Vietnamese POW camp.
"I never lost faith in the end of the story, I never doubted not only that I would get out, but also that I would prevail in the end and turn the experience into the defining event of my life, which, in retrospect, I would not trade."When Collins asked who didn't make it out of Vietnam, Stockdale replied:
"Oh, that’s easy, the optimists. Oh, they were the ones who said, 'We're going to be out by Christmas.' And Christmas would come, and Christmas would go. Then they'd say, 'We're going to be out by Easter.' And Easter would come, and Easter would go. And then Thanksgiving, and then it would be Christmas again. And they died of a broken heart."Stockdale then added:
"This is a very important lesson. You must never confuse faith that you will prevail in the end—which you can never afford to lose—with the discipline to confront the most brutal facts of your current reality, whatever they might be.”Jim Collins talks about the Stockdale Paradox here and here and argues that only by disciplined thought can greatness be achieved
Retain unwavering faith that you can and will prevail in the end, regardless of the difficulties, AND AT THE SAME TIME have the discipline to confront the most brutal facts of your current reality, whatever they might be.
Gaps filled
In comments guppytrader alerts to the missing link, contained within the link, so we now have a somewhat clearer picture. I have estimated the $ value of of the 4,634 tests in 2006 and for what it's worth, I have added a trendline;
September 14, 2010
University of Illinois Chicago
Back in 2006 UIC said that they had done 4,643 Quantiferon. Then in 2009 they said that they had done 7,499. Last May UIC called for tenders to supply an estimated $US1.17M QFT over 3 years, which works out to roughly 56,000 tests.
I dont have data for other years so they remain blank
This is how it looks in a graph however it should not be regarded as definitive,
only indicative of future sales;
I dont have data for other years so they remain blank
This is how it looks in a graph however it should not be regarded as definitive,
only indicative of future sales;
September 12, 2010
Great Unhinging III
Pastor Danny Nalliah laments that the Independents chose to act independently thereby endorsing government by atheists and homosexuals;
If given the opportunity, would you support a political party which will take Australia back to the historic roots of its Founding Fathers, the Ten Commandments, and that will protect our Judeo-Christian heritage??Silly as a two bob watch
QuantiFERON assisting with resource management
Details here
Experience with the use of Quantiferon test, a novel method to detect tuberculosis, in two arthritis centers in Budapest, Hungary
István Á. Juhász1, Judit Korda2, Bernadette Rojkovich1
1Polyclinic of the Hospitaller Brothers of St. John of God, 2National Institute of Rheumatology and Physiotherapy, Budapest, Hungary
Because the immunosuppressive effect of biological treatments is well known the early recognition of infection is of utmost importance for arthritis centers administering biological therapies. TB occupies a prominent place among the adverse effects of TNFalpha inhibitors and several diagnostic procedures exist for its detection. Although culture is the most definitive test, it takes too much time. Intracutan tuberculin test with purified protein derivate (PPD) requires less time, however it is not specific for human pathogen Mycobacteria and it gives positive reaction in patients immunized with Bacillus Calmette-Guérin (BCG).
Discrimination between BCG vaccination and tuberculosis infection is possible using the gamma-interferon (Quantiferon) test that is less time consuming but more expensive than PPD. The experience gained during the use of Quantiferon test in the setting of biological therapy in two arthritis centers in Budapest is presented. The authors analyze the collected results of this recently introduced test on a limited number of patients, taking into account the immunosuppressive effects of co-medication, and give their opinion during a case presentation of a 50-year-old man with SPA treated with infliximab who developed TB and was diagnosed with the use of Quantiferon test.
September 10, 2010
The Great Unhinging II
The Australian ramps up the hyperbole;
Christopher J Sichok, from the Murdoch University (not related), agrees;
Greens leader Bob Brown has accused The Australian of trying to wreck the alliance between the Greens and Labor. We wear Senator Brown's criticism with pride. We believe he and his Green colleagues are hypocrites; that they are bad for the nation; and that they should be destroyed at the ballot box.But of course they would say that, political interference is business as usual for Murdoch
Rupert Murdoch's News Corporation, the media juggernaut that owns Fox News and the Wall Street Journal, gave $1 million to the Republican Governors Association in June.No sense of irony in the following
A News Corp. spokesman told The Upshot that the the corporation "has always believed in the power of free markets.."A million bucks a lot of free market.
Christopher J Sichok, from the Murdoch University (not related), agrees;
These corporations have transformed speech from political persuasion (which it was before the entertainment-based "information age") into profit, or at least private gain, thus eroding the spirit of the First Amendment.
Trickle down effect of CDC guidelines
The University of North Carolina have updated their website to reflect the updated CDC guidelines on interferon gamma tests for TB
CDC appear to be doing a good job in keeping everybody informed of those changes;
TB blood tests or the TST is acceptable for testing, but the CDC prefers the blood tests (e.g. QFT-G or T-SPOT) for persons who have received BCG vaccine or who will have difficulty returning to have the TST read.They have also included a long list of caveats dealing with the TST eg
What Are Possible Side Effects of the Skin Test? Infrequently, redness or other reactions may occur at the test site. In highly sensitized persons, strongly positive reactions to the tuberculin skin test may include blistering, ulceration, or necrosis at the test site. Cold packs or topical steroid preparations may be used for symptomatic relief of itching and discomfort. Scarring may result from strongly positive reactions.Yecch!
CDC appear to be doing a good job in keeping everybody informed of those changes;
Labels: cdc, igra, quantiferon, University of North Carolina
September 8, 2010
Let the Great Unhinging begin
Scott Steel writes about the newly elected Gillard coalition government;
With two country independents backing Gillard, the Labor party will now pass the only threshold needed in Australia to form government – a majority on the floor of House. There is no other test, there is no other requisite, there is no other qualification needed to control the Treasury benches.
But this constitutional reality will not stop some. Indeed, it merely marks the beginning of what will become a long festival of delusion, conspiracy and outright lies – where its hysteria will only be surpassed by its grubby bitterness and its commercial exploitation.
Do you get the picture now?
Spokane has updated their website to include.....QuantiFERON-TB Gold In-Tube.
Not just once or twice but many times;
Not just once or twice but many times;
Labels: quantiferon, spokane
September 7, 2010
Word games
In conceding defeat Tony Abbott said
The Coalition won more votes and more seats than our opponentsThis is somewhat disingenuous; the coalition's opponents being another, better coalition. Looking at the polling we see that the Abbott coalition ("The Coalition") was eventually comprised of
- Liberal 44
- Liberal National Party of Queensland 21
- The Nationals 7
- Country Liberals 1
- Independent 1
- Australian Labor Party 71
- The Greens 1
- Independent 3
September 6, 2010
Seattle Children's Hospital
doc gt points us in the direction of Seattle Children's Hospital
Children's will now use an interferon gamma release assay (the brand name is Quantiferon - TB Gold) for TB screeningBut what about the skin test?
If you prefer to get a TB skin test rather than the blood test, skin tests will still be available by appointment at the Roosevelt Commons buildingSeattle Children's run clinics everywhere
Here is a comprehensive list of our locations in the state of Washington. For information about our clinic locations in Alaska and Montana, please see Alaska Locations and Montana Locations.So, is Seattle Children's a Big Deal? seems so
Labels: quantiferon, Seattle Children's Hospital
WHO and The Big Picture
The TB Alliance recently held a two-day Open Forum on TB drug development and all the big kahunas making their presence felt,
Open Forum 4 was supported in part by grants from Aptuit, AstraZeneca, Bayer Schering Pharma, Celgene, GlaxoSmithKline, Novartis International AG, PharmaNet, Pfizer, sanofi-aventis, and Tibotec.One of the keynote speakers was Dr. Haileyesus Getahun from WHO who made sure that everyone understood that to be successful achievement of Millennium Goals must include latent TB
Labels: latent tuberculosis, millenium goals, who
September 4, 2010
Notes from Dr. RW
Dr RW writes about IGRA - note that his blog gets a pretty good coverage
In turn Dr Nicholas Genes writes about Dr RW in Medscape;
FRIDAY, SEPTEMBER 03, 2010
CDC guidelines on Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection
The assay can be considered as an alternative to the tuberculin skin test. In many patients it's either/or. In some cases the new assay may be advantageous, as in patients at risk not to return to have the skin test read at the proper time
In turn Dr Nicholas Genes writes about Dr RW in Medscape;
A hospitalist in Arkansas finds his voice online, and keeps up to date with new literature by offering thoughtful, nuanced commentary.
September 3, 2010
Small & Pai on the MTB/RIF
Here
In a large, well-conducted, multicountry study, Boehme et al. evaluated an automated tuberculosis assay (Xpert MTB/RIF) for the presence of Mycobacterium tuberculosis (MTB) and resistance to rifampin (RIF). With a single test, this assay identified 98% of patients with smear-positive and culture-positive tuberculosis (including more than 70% of patients with smear-negative and culturepositive disease) and correctly identified 98% of bacteria that were resistant to rifampin.8
The assay has several critical advantages over conventional nucleic acid–amplification tests, which have been licensed for nearly 20 years and yet have not had a substantial effect on tuberculosis control. The MTB/RIF assay is simple to perform with minimal training, is not prone to cross-contamination, requires minimal biosafety facilities, and has a high sensitivity in smear-negative tuberculosis (the last factor being particularly relevant in patients with HIV infection).8
However promising these findings, issues involving the MTB/RIF assay may limit its global utility. These issues include its high cost, limitations in testing only for rifampin resistance, a platform that detects a relatively small number of mutations, and inability to indicate which patients are “sputum smear–positive” for reporting purposes, infection-control intervention, and treatment monitoring.
On the plus side, the MTB/RIF assay promises to decentralize molecular diagnosis, since it potentially can be used at the point of treatment in a microscopy center or in a tuberculosis or HIV clinic. However, because Boehme et al. used the test at reference laboratories, their study offers only indirect proof of concept for use in such settings. Critical to a rapid scale-up of the test will be the results of additional studies to determine how it performs in such settings and whether its use improves outcomes for patients in a cost-effective manner.
If an improved rapid nucleic acid–amplification test is adopted globally, it could help avert more than 15 million tuberculosis-related deaths by 2050.9 However, even the most promising diagnostic test will have only limited impact if it does not reach the patients who need it. As with any diagnostic test or intervention, its actual impact will depend on the system in which it is used. Health systems must be strengthened so that patients do not delay in seeking care and have prompt access to appropriate treatment once they receive a diagnosis. Health-system barriers to the use of improved technologies must be anticipated and addressed. Although the burden on health systems will be reduced by a simple dipsticklike, point-of-care assay, such tests are not likely to be available in the short term.
Been there, done that
News of the new MTB/RIF test has sent the share price of the producer soaring
Granted that the time taken to perform the test is a great advantage however it is still not as accurate as the sputum culture test, which is the "gold standard". As the proponents claim, it may well be a contender for smear, which has a poor track record. However, the advantage that it can detect RIF resistance may be significant in treatment and in contact tracing.
The treatment of drug resistant TB is still being explored and the combination of existing drugs with Moxifloxacin has shown that, in some cases, decreased resistance whilst in other cases it has the potential to decrease treatment time.
So as always, it will take time to properly evaluate the benefits.
Up $1.35, or 8.6 percent, to $17.12 in afternoon trading.Rumours of "blue sky" abound
Jefferies & Co. analyst Bruce Cranna said the company could get a big boost if the World Health Organization recommends the test to its 193 member states.But is the hype warranted?
Granted that the time taken to perform the test is a great advantage however it is still not as accurate as the sputum culture test, which is the "gold standard". As the proponents claim, it may well be a contender for smear, which has a poor track record. However, the advantage that it can detect RIF resistance may be significant in treatment and in contact tracing.
The treatment of drug resistant TB is still being explored and the combination of existing drugs with Moxifloxacin has shown that, in some cases, decreased resistance whilst in other cases it has the potential to decrease treatment time.
So as always, it will take time to properly evaluate the benefits.
Labels: active Tuberculosis, moxifloxacin, MTB/RIF
September 2, 2010
New test identifies TB disease in under 2 hours
Study here, note it is for active TB not latent (ie disease not infection)
The MTB/RIF test provided sensitive detection of tuberculosis and rifampin resistance directly from untreated sputum in less than 2 hours with minimal hands-on time. (Funded by the Foundation for Innovative New Diagnostics.)The news has captured headlines
"You can tell the patient before they leave the office if they have TB and if it's drug-resistant. It's transformational," said Dr. Peter Small, head of TB programs at the Bill & Melinda Gates Foundation, which helped fund the work, along with the U.S. government.
"The Citizen News Service (CNS)..
..syndicates content generated in four languages (English, Hindi, Urdu and Thai) by voluntary citizen journalists on issues they are dealing with in daily life, under creative commons attribution license."
Contributor Shobha Shukla reports on an exclusive interview held in Ethiopia with Dr Christian Lienhardt, of the Stop TB Department of WHO
Contributor Shobha Shukla reports on an exclusive interview held in Ethiopia with Dr Christian Lienhardt, of the Stop TB Department of WHO
Dr Leinhardt mentioned some existing modern diagnostic tools, some of which can shorten the time of diagnosis to as less as 2 hours.. One of them is LED Microscopy ... the Interferon Gamma Release Assay (IGRA) test..
...The WHO recommends the use of these tools as they can dramatically shorten the time taken for diagnosis, which is a crucial factor in TB treatment.
Interferon-gamma-release assays: Better than tuberculin skin testing?
That is the title of this article in the latest edition of
ABSTRACT
Although the tuberculin skin test has long been the standard for detecting latent tuberculosis infection, it has many limitations. Interferon-gamma-release assays are gaining acceptance as an alternative. In this paper we present cases to illustrate how these new tests can be used and how to interpret the results.
THE FUTURE OF TUBERCULOSIS TESTING
Given the wide availability of interferon-gamma-release assays and laboratories that process them, more tuberculosis control programs will probably start using them rather than tuberculin skin testing. Successful implementation requires education of everyone involved — phlebotomists, laboratory personnel, occupational health workers, and clinicians. Further study is needed to evaluate the feasibility, utility, costeffectiveness, and value of using these new tests. ■
Why do Kiwis prefer QuantiFERON?
There are relatively high rates of BCG-vaccinated individuals and immigrants among healthcare workers in New Zealand.
Healthcare workers (HCWs) are at risk of occupational exposure to TB, so may need multiple tests to screen for LTBI during their working life. Use of IGRAs avoids the need for baseline two-step testing, as well as the occurrence of boosting and sensitisation that can be complications of serial Mantoux testing.
IGRA results will be stored in the laboratory system, which should facilitate the transfer of information between District Health Boards should HCWs move between regions.and
A number of District Health Boards are shifting away from using the Mantoux due the logistics of delivering the test and are now using the QuantiFERON Gold assay for pre-employment screening.
Labels: health care worker, new zealand, quantiferon
September 1, 2010
Updated Kiwi guidelines - NZ steps up to the plate
Available here - in principle the guidelines reflect those of the US CDC - QFT gets a guernsey - perhaps now might be a good time for Australia to consider the evidence and move forwards?
Labels: new zealand, quantiferon, tuberculosis guidelines
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