Scrambled eggs

At the recent Cellestis AGM they made mention of of sales subsequent to reporting 

in first 4 months of FY2010 in US, EMEA and ROW – On an average monthly basis, 37% growth over same period last year

and Japan

likely flat for the first half

Of course these sales have to be then converted back to $AUD and it is then that foreign exchange (Forex) comes into play. We know that there has been significant movement in the $US yet from the following charts the movement has been confined to a relatively small period. How this pans out depends, to some extent, on the skill of the financial controller in shifting currencies.

I dont know where this one is going...

This study from Italy included the following observation;

Another study reported that in a mostly BCG-vaccinated Korean control population, 51% of the subjects were TST+ and only 4% were QFT-IT positive, while the expected prevalence of M. tuberculosis infection was 33% 

It wasnt quite like that, the referred Korean study (published 4 years ago) came from a population with an intermediate TB burden and substantial BCG vaccination in which the selected group was divided up into 4 categories according to their risk of infection;

#1, no identifiable risk of M tuberculosis infection (n = 99);
#2, recent casual contacts (n = 72);
#3, recent close contacts (n = 48);
#4, bacteriologically or pathologically confirmed TB patients (n = 54)

When using QFT-GIT the results for these groups were;
#1, 4%;
#2, 10%;
#3, 44%;
#4, 81%

whereas for the skin test
#1, 51%;
#2, 60%;
#3, 71%,
#4, 78%

The Korean researchers had no problem finding that

IFN-gamma assay is a better indicator of the risk of M tuberculosis infection than TST

The Italian study focussed on 106 healthy TST⁺ individuals with suspected LTBI (recent contact of smear-positive TB and homeless). They felt that the TST response was valid because of 2 reasons;

1. they had high risk factors
2. they had a great TST response

however the results of the QFT-GIT caused them to pause and reflect

the observation that almost 34% of the these TST⁺ individuals had negative results by QFT-IT may reflect, at least in part, a less than perfect sensitivity to this test for detecting LTBI.

Of course it is one thing to fiddle around the edges of the results and another to actually gain results that are meaningful

the amount of the refusal rate among the homeless [refusal rate was 4.3% (13/300) at recruitment, 10.1% (29/287) for the TST reading, and 11.8% (7/59) to undergo further investigation for those resulted TST+] that may have accounted for a selection of the subjects tested.

Why are these researchers still ploughing the same old fields?

Meet the market

Despite IGRA being specifically designed for latent TB there seems to be a growing need for IGRA to be used in active TB. I guess that given the nature of the active TB diagnostics it isn't quite so easy to diagnose active TB especially when the patient is unable to cough up enough material to diagnose, as is the case with children or the elderly or the sick.

In the UK they are now using IGRA to increase the sensitivity of the TST

The trend my friend.

Medicare data for October confirms that for some time QuantiFERON usage in Australia has "tipped", previous chart here.

Technical analysts can analysis this (click on image for FULL SIZE);

US economy showing signs of recovery

Richard Berner from Morgan Stanley takes a positive but bumpy outlook

In our view, the reversal of those systemic shocks is now promoting recovery, and renewed gloom about the economy and concerns about an intensifying credit crunch are overdone.

Recovery will flow through to all sectors;

As growth in bank earnings accumulates, and banks repay those loans, the excess liquidity will likely translate into securities purchases and loan growth.

RBA forecasting a boom

From Deputy Governor Ric Battellino

The Australian economy in 2009 has held up much better than had been expected earlier in the year. Australia is the only developed economy where year-ended growth in GDP has remained positive during the past year. It is now 18 years since Australia has experienced a negative in year-ended GDP growth, a very prolonged economic expansion. With the economy having only recently entered a new upswing, it is reasonable to assume that we will see this growth extended for a few more years yet.

Over the next few years, Australia is also expected to see a further expansion of the resources sector, including the development of some very large gas projects. Mining investment, which is already at record levels as a share of GDP, could rise substantially further in the next five years or so

If this scenario eventuates, it will have powerful and broad-ranging implications for the economy.

Minnesota and HCWs

Minnesota narrows the choices available for baseline testing; either IGRA or a 2-step TST.

Baseline TB screening is required for all healthcare workers (HCWs) in Minnesota.

The same applies for patients to health care settings in Minnesota;

All residents must receive baseline TB screening within 72 hours of admission or within 3 months prior to admission.

From little things big things grow.

A Californian doctor recounts his experience to the 2009 Chest Conference;

Local Health department recommend the use if (sic) IGRA (QuantiFERON-TB Gold assay) as this is more specific in people vaccinated with BCG

Non pulmonary TB and QuantiFERON

An article in Springerlink describes how QFT™ was successfully used to diagnose active TB when microscopic examination of acid-fast bacilli and DNA by PCR was negative.

Cellestis gets a guernsey

Writing in Fairfax media's BusinessDay Jamie Freed takes a sneak preview of Lincoln Indicators' biannual market health report, to be released today.

..some smaller companies also have solid enough financial metrics to be considered much less speculative than their peers. Lincoln's top small cap picks include Forge Group, Tox Free Solutions, Cellestis and North Queensland Metals.

Also was Bioshares wrap up of the AGM

The CEO of Cellestis, Tony Radford, crafted his AGM address around several themes, one of which was the need to invest in marketing.

In discussing the full year results (to June 30, 2009), in which sales increased by 83% from $18.8 million to $34.5 million, and profit rose by 391% from $1.7 million to $8.2 million, Radford pointed out a significant increase in expenditure on marketing and business development expenses.

"If you take away a message it is that we invest heavily in marketing”, said Radford. The company now has a team of seven devoted to marketing and business development.


Summary
Cellestis continues to impress with its unwavering focus on its business, its strong sense of discipline and the balance it brings to rewarding shareholders but at the same time making necessary investments in marketing efforts that will help the company increase its market share from the 4% it currently holds.

Bioshares recommendation: Hold

Medical devices from a lawyers perspective

US law firm Foley & Lardner LLP have sent out this advice to the Medical Device Industry.

Topics include:
health reform bills - changes to reporting procedures may free up red tape;

patents - infringements of US patent law made outside the US are not actionable within the US and a method or process is not a component (the law only applies to tangibles not intangibles);

branding - doctor recommendations are paramount;

mergers and acquisitions - ability to conserve capital and self fund is critical

TB outbreak in maternity unit - chaos

Drs Tara Greenhow and Deboarah Gold use docstoc to recount their experience when active TB is found in a maternity unit in San Francisco. Analysis indicated that 960 mothers and babies were at risk of exposure.

QFT was used on 152 that were BCG vaccinated;

If QFT-G was not available, 120 additional infants would have had to take INH

Things that worked well;

SF DPH TB Control assistance and help obtaining Quantiferon Gold testing

Amongst the surprises

Difficulty to complete TB screening of HCW screening in a crisis

.

Getting it straight, from Zagazig

Someone on Twitter put up this slide presentation from Zagazig University, Egypt - another "must see" destination for the QFT world tour.

Zagazig University is located in Sharkia Governorate, which is one of the largest governorates in Egypt...Sharkia Governorate is very well-known by Arabic horses , Ducks hunting, Pharos imprints and templates

Anyway, only 1 slide is needed to get the picture;

More AGM agony

One of the questions asked was why wasnt the financial press invited to the meeting?

The answer to that lies within the Notice of AGM, ASX Corporate Governance Principles and Corporations Act;

QFT false negatives

Japanese doctors said "we have to consider the possibility of false negative."

Consider it considered;

AGM agony

One of the questions to the board at the 2009 AGM dealt with the tardiness of the Australian regulatory authorities. Some consternation was expressed that this attitude has dampened the take up of QFT and reference was made to available Medicare data - was take up 40% or 14% or 24% - did it have a 4 in it?

Using the the Medicare data as a guide Australians are paying less attention to these particular bureaucrats;

Bureaucracy 2.0

The latest notice from the relevant department reads as if from October 14, 2009 only the IGAR should be used. I doubt if that was their intention however that is how it scans;

(click on image for FULL SIZE)

As slow as a month of Sundays

Not to be outdone, NICE  confirm that with sufficient resources they can be as just as slow as their foreign counterparts;

Tuberculosis: interferon gamma tests (update)

Dollar dazzlers

Paul De Grauwe writes that there are two scenarios for the $US

monetary authorities have to choose between a policy that accommodates for the high demand for dollars in the world

or

the US sticks to the inflation target, but this requires limiting the supply of dollars to a much lower level, frustrating the high demand for dollars worldwide.

Mayo Clinic - the "hot topic" is QFT-GIT

Here is the link, everything you wanted to know, plus more,  all about QFT-GIT

TB firmly back in UK public eye.

This article puts TB back into the news; a middle aged middle class anglo woman who thought that she was going through menopause found out that she had TB (confirmed by a blood test and a sputum test). She is convinced that she contracted the disease on public transport or a crowded public area in London. Another woman, a 27 year old a postgraduate law student at Sussex University thought that she had asthma - despite successful treatment she has had to have a lung removed;

TB has definitely affected my long-term health and I'm frustrated that my symptoms weren't picked up earlier,' she says.

'There's still a stereotype about who gets TB, and because I'm a white middle-class female it never crossed my doctor's mind I might have it, even though I lived in Ealing, an area of London with quite a high incidence rate.

'It doesn't matter who you are or where you come from - anyone can get this disease.'

Statistics and policy

Greg Mankiw points to a report put out in January 2009 by President Obama's economic advisors Romer and Bernstein in which the effects of the stimulus on employment were described;

Here is the reality

IGRA, TST and dialysis patients

Whilst TST false positives are to be expected higher rates of T-Spot indeterminates were not.

What's new with IGRA? A Sneak Peek at the Provisional Guidelines

Dr Christine Ho., a CDC Field Medical Officer with the San Francisco TB Control giving a powerful presentation at Lung Colorado;

###

• IGRA is preferred for testing persons:
– with poor rates of return for TST reading
– who have received BCG (as a vaccine or for cancer therapy)

• TST is preferred for testing:
– children younger than 5 yrs of age

###

Regarding QFT-G…..
This has been the single biggest advance in delivering healthcare to people who are homeless in my 20 years of doing healthcare.

Barry Zevin
San Francisco homeless healthcare provider
May 5, 2008

University of Toledo ups the ante

Graduate Council Minutes
September 8, 2009

New TB Screening Policy– World Health Organization has identified 29 countries with endemic multidrug resistant TB. In the interest of student health and wellness, a new UT policy was created by a team from Medicine, International Services and Admissions and COGS and implemented this fall.

All new and continuing students from an identified country must be tested. If a student tests positive then a designation of HH (health hold) on a student’s account and the Student Medical Center must do a follow up screening. A positive result could mean the person has latent TB, but once the student starts treatment he/she can attend classes. About 380 new students were tested with the Quantiferon test (QFT) and 56 positives were found and referred for additional screening. Letters will go out soon to continuing students originating from those countries to inform them about the QFT necessary screening. The QFT cost is $36.

Travel medicine and TB

Expert commentary from the International Society of Travel Medicine (ISTM) (file now removed, see below the fold for full article)

I therefore favor the use of IGRA testing for our patient

..The TST alone, in this BCG-vaccinated woman from Mexico, does not have sufficient positive predictive value for us to embark upon prophylaxis based solely upon her positive test result. IGRA testing offers both increased test specificity for M. tuberculosis and positive predictive value for latent infection. It will allow us to make this decision in a more definitive and confident manner.

IGRA and immigration

Latest memo from U.S. Citizenship and Immigration Services (USCIS)

With the update to the TB component of the Technical Instructions, and under the revised version of the Form I-693, a civil surgeon may now administer an interferon gamma release assay (IGRA) in place of a Tuberculin Skin Test (TST).

Market rate of intelligence

Listed under "what ever will they study next" is this paper from the University of Chicago that looks at IQ and stock market participation;

The evidence presented so far indicates that cognitive impairment prevents some individuals from holding stock

..even among those who hold stocks, low IQ investors are likely to hold more poorly diversified portfolios.

Interestingly they find that it is intelligence not wealth that influences participation

Our findings support cognitive impairment as a key driver of non-participation.

..we find that IQ’s role in the participation decisions of the affluent is about the same as it is for the less affluent.

Testing HCWs in Singapore

It doesn't get any clearer than this;

The high rate of positive baseline TST results in our BCG-vaccinated healthcare workers renders the TST unsuitable as a surveillance tool in this tuberculosis risk group. Use of an IGRA has enabled the detection and treatment of latent tuberculosis in this group

Exploring immune response of TB for a better diagnosis of infection

Here we have Ferrara et al from Italy looking at advances in TB diagnosis; of IGRA they note that their

wide use in clinical practice, the availability of phase III studies, and the initial data on their predictive values make them the best candidates to substitute TST in the near future.

Do the maths Kevin

During the 2007 election campaign Kevin Rudd promised

Today I announce that, if elected, Federal Labor will undertake a groundbreaking reform by providing for every Australian secondary school student in Years 9 to 12 access to their own computer at school

The promise was to be continued with upgrades

This will not just be a one-off investment.

We'll fund the replacement of these systems to keep them at the cutting edge.

Data from a Victorian survey indicates that less than 1 in 3 students have access to a computer