QF-CMV FDA Approval

"floyd" asks:

would anyone happen to know how far down the track cst is in getting fda approval for qf-cmv? 

I am advised that the data for the submission for FDA approval for QF-CMV is in the final stages of preparation. This will be a 501K approval and therefore will not take anywhere near as long as the approval for QFT-TB Gold took. I imagine months, rather than years.


Don't forget that we already have CE-Mark for Europe and can therefore sell in Europe immediately.

And more on QuantiFERON-CMV

(Of course Doctor Who is tomorow night)


It seems that Cellestis have updated the documentation on their website to reflect the release of the International Consensus Guidelines.


You can see them here.


Of particular interest is the new CMV Physician Brochure


It's great to see this evidence of the CST Marketing machine jumping into action. Hopefully an indication of what we will see when the CDC IGRA Guidelines for TB Diagnosis are released.


I believe that there are currently about 70,000 solid organ transplants conducted in the developed world each year. Each of these would require several uses of QFT-CMV both before and after transplant. I am not aware of the price of QFT-CMV but I believe it will be significantly more than the price of QFT-TB Gold. 


I am also reliably informed that the acceptance curve of this diagnostic will be quite different than that of QFT-TB. That is, acceptance should be very rapid as transplants are high value operations conducted by surgical teams who work at the "cutting edge" of medicine and are therefore prepared to quickly adopt procedures, practices and products that improve the outcome of their surgery. 


And, while I am jotting down random points, I believe that this full commercial release of QuantiFERON-CMV has another benefit for the company. It builds on the brand recognition of the QuantiFERON brand. That is of great benefit in facilitating the acceptance of both current and future QuantiFERON products.

QuantiFERON-CMV

I'll have something to say about QFT-CMV later but I'd rather watch Doctor Who tonight, so I'll start by repeating my description of QFT-CMV from earlier in this blog.


QuantiFERON-CMV


This is quite an interesting diagnostic that actually begins to open up the view that the QFT Technology has a huge number of potential applications.


Cytomegalovirus (CMV) is a herpes virus that infects between 50% and 85% of the population. Similarly to TB, it remains in a latent form in the body and causes no problems for people under normal circumstances. Again, the competent immune system deals with CMV quite effectively.


However, it poses special problems for transplant patients. If a donor recipient that does not have the T-cells to fight CMV receives an organ from a donor with CMV, the recipient is at huge risk of developing full blown CMV which, at worst, can result in death. Furthermore, the anti-rejection drugs administered after transplant can weaken the immune system enough for CMV to become active.


As opposed to QFT-TB, QFT-CMV is not used to determine if somebody has CMV - rather it is used to determine if somebody has the T-cells to fight CMV. It is important that this status be established before transplant and monitored during post operation recovery. This is the role of QFT-CMV. 


There are currently about 70,000 solid organ transplants performed in the world each year - each of these transplants would require multiple uses of QFT-CMV. Clearly, CMV is not going to generate the same income as QFT-TB (even though it sells at a price of multiples of QFT-TB). However, over time (particularly as the number of transplants increase) it will generate significant income.

While we were distracted. QuantiFERON CMV.

We may not yet have our CDC Guidelines for Quantiferon TB but today "International Consensus Guidelines on the Management of Cytomegalovirus in solid organ transplantation," have been published. 


Read the press release for yourself but they reinforce the use of Quantiferon-CMV.


New Blood Test Successfully Predicts Risk of Infection in Transplant Recipients

International guidelines support advances in immune monitoring

MELBOURNE, Australia, April 23 /PRNewswire/ -- New international guidelines published in the journal Transplantation reinforce the use of a new type of blood test to assess cytomegalovirus (CMV) risk in solid organ transplant recipients (i.e. transplant recipients).  This blood test, QuantiFERON®-CMV (QF-CMV), is the first commercially-available blood test to allow physicians to monitor a person's risk of CMV disease.  Most commonly used in the transplant setting, QF-CMV may predict which transplant recipients are at increased risk of CMV disease after transplant surgery.

"For transplant recipients whose immune systems are already compromised by anti-rejection medications, the emergence of immune monitoring of CMV-specific T-cell responses in transplant medicine is an exciting development," said Assoc Prof Atul Humar, Director of Transplant Infectious Diseases, Department of Medicine, University of Alberta, Canada. "Immune monitoring may potentially allow physicians not only to gauge a patient's risk of developing post-transplant CMV disease, but also to assist in determining the most appropriate management pathway on an individual, patient-by-patient basis."

About CMV Testing and Immune Monitoring in Transplant Recipients

CMV is the most important infectious cause of post-transplant illness and death,  affecting approximately half of all transplant recipients. CMV disease leads to increased resource utilization and total transplantation program cost. Although preventative therapies are available for CMV and have been shown to be effective in preventing CMV disease, many transplant recipients still develop CMV disease in the months immediately after the end of their therapy. Current standard practice is to assess CMV status of both donor and recipient prior to transplantation.  A serology test is usually used for this pre-transplantation assessment. In a post-transplantation setting, where serology tests are limited because they cannot diagnose "active" CMV disease, CMV testing is most commonly completed using tests that detect the presence of the virus (i.e. viral load testing). Such tests are currently used to guide patient care and treatment.

Current guidelines indicate that monitoring transplant recipients' cellular immune responses to CMV can help a physician predict which transplant recipients are at increased risk of developing CMV disease.  A physician's ability to monitor the CMV immune status of transplant recipients may be useful in guiding the prevention and treatment of CMV disease after transplantation.

About the International Guidelines

The recently-published "International Consensus Guidelines on the Management of Cytomegalovirus in solid organ transplantation," the first-ever such guidelines, suggest that an ideal immune monitoring assay should assess the quantity and function of a transplant recipient's CD-4+ and CD-8+ T-cells and that such an assay should also:

• Be able to measure interferon-gamma (IFN-gamma)
• Be simple to perform, cost-effective, and reproducible
• Have a rapid turnaround time,
• Allow for specimens to be easily shipped to specialized referral laboratories.

About the QuantiFERON-CMV test

QF-CMV, a simple blood test, meets virtually all the criteria specified by the guidelines.  This new monitoring tool measures a person's CD-8+ T-cell immune response to CMV. It is the only standardized, commercially-available immune monitoring assay, specific for CMV.

Studies now highlight that monitoring a patient's level of immunity to CMV using QF-CMV could help guide the optimal duration of costly CMV preventative therapy in high-risk patients.

QF-CMV is a major advance in the management of CMV disease risk in transplant recipients. In this setting, QF-CMV is particularly useful for:

• Predicting the likelihood of CMV disease in high risk populations.
• Guiding the clinical and therapeutic management of high-risk patients.
• Decreasing the incidence of late-onset CMV disease and associated healthcare costs.

About Cellestis Limited

Cellestis Limited, a listed Australian biotechnology company founded in 2000 in Melbourne, Australia, develops and manufactures the QuantiFERON-CMV test, a breakthrough blood test for monitoring cytomegalovirus infection and disease, and the QuantiFERON-TB Gold In-Tube (QFT®) test for tuberculosis infection. Using its patented QuantiFERON technology, Cellestis develops diagnostics tests that measure immune function for diseases with an unmet medical need.

QuantiFERON-CMV is sold in Europe by Cellestis GmbH (Germany); and in Australia and Asia by Cellestis International Pty. Ltd. (Australia). QuantiFERON-CMV may also be available through commercial partners in Japan, Europe, the Middle East and other countries worldwide. QuantiFERON-CMV is not US FDA-approved and is available for investigational use only in the US. QF-CMV is not a test for CMV infection.

Visit www.cellestis.com  to view full details including references regarding QuantiFERON-CMV.

It's not Caviar.

Return on Equity (ROE)


Let me start with a note of explanation. I am sure that to many of you these simplistic explanations of mine of topics like PE and ROE are "old hat". To you, I apologize - you have my permission to skip these posts. However, I would like to think that there may be some people out there who might gain something from my ramblings. I personally enjoy thinking about these things (writing helps me think) and attempting to reduce them to relatively simple and understandable descriptions. 


Ok.


Return on Equity is ... well ... the return on equity that a company makes. 


To make any sense of ROE we need first to understand what equity is. To an accountant this will come as second nature. Even to somebody that understands double entry bookkeeping (me) it is not too hard to understand. (Probably the most useful thing that I know, to assist me in my investing activities, is an understanding of double entry bookkeeping - keep that in mind if you find yourself looking for something useful to learn).


Equity is what a company "owes" you, the investor. It is the sum of all the money that you have invested in* the company, plus all the profits that the company has ever earned, less all the losses that the company has ever made, less all the money that you have taken out of the company (usually as dividends). 


* (did you notice the asterisk). There is a very important point here. We have to make a very clear distinction between the financial operations of the company and the way we invest in the company through the share market. It's really, really important that we have this distinction very clear in our minds - not only for an understanding of equity but for an understanding of all aspects of our investment. Let me explain a little further. When you buy shares on the stock market you are not buying them from the Company, you are buying them from another investor. The money that you pay does not go to the company. The price you pay for those shares is entirely between you and the seller - it does not change anything at all about the finances of the company itself. 


So, we need to expand a little on the statement "...the sum of all money that you have invested in the company". The "money" that we are talking about here is not the money that you have paid for the shares but the investment in equity that the seller is selling you. In fact, in most cases, the equity that you are buying will be a lot less than the share price that you are paying.


For example ... let's just pick a company at random .... hmmmm .... Cellestis. As at 30th December 2009 the Equity per share was 24c but the Share Price was $3.27.


(end of asterisk bit)


So, now we (hopefully) know what equity is we can easily understand what Return on Equity (ROE) is. It is just the Company Earnings / Equity.


But what use is it?


That's the important question.


It's not unusual to see a list of Companies presented with their respective ROEs. To me, such a list is easily misunderstood to provide some sort of numerical comparison between the Companies. Surely a company with an ROE of 25% is better than one with an ROE of 15%? 


'Aint necessarily so.


Even very simplistically we can see that it is not possible to compare two possible investments based purely on their ROE. It would depend upon the price you are paying for the equity. Of course you could factor the share price in but it achieves little - it actually just takes you back to a PE value.


There is more, much more to it.


A very common mention of ROE is in the description "ROE is a measure of how effectively a Company is using it's assets* to generate income". That is true, as far as it goes.


*(another asterisk) On a balance sheet, equity = net assets.


That fact alone may be useful in comparing two similar companies. It is less useful when comparing quite different companies (An earthmoving company probably needs more assets to generate it's income than a software company). It's almost a measure of efficiency. If two companies, Company A and Company B are operating in similar businesses but Company A has a higher ROE then, on the surface, it is using it's assets more effectively. Why would this be so? Many reasons. Maybe Company B owns a $5m office building whereas Company A has used the $5m to buy a few more bulldozers and rents an office. Stuff to look for.


Here's the really interesting part. Marginal ROE.


What we are talking about here is the ability of the company to use additional equity to generate additional profits. Specifically, can they maintain (or improve) their existing ROE with additional equity. After all, we would like to see the Company we have invested in grow over time.


How do we establish this? Firstly we just apply some common sense. If the Company is operating a fruit juice shop in three shopping centres, each of which is generating good profits and a good ROE then we might assume that they can use some additional equity to open more shops in more shopping centres, each operating just as successfully as the first three. Until they have a shop in every shopping centre (all else being equal) this can continue. On the other hand, if the company has the sole supply contract for facemasks to Government Hospitals, it may not be able to use any additional equity effectively. There are many permutations - some companies can use additional equity to improve ROE, others can use equity to grow the business but at a lower ROE and others may not have a use for additional equity at all.


Secondly, if the company has been operating for some time we can look at it's historical use of additional equity.   


How does a company get additional equity? Three main ways.

1. Borrowing.
2. Raising additional capital from the market (ie issue more shares).
3. Retaining profits.

Borrowing can be really good for a Company. If the Company can receive a return on the borrowed funds that is greater than the cost (interest) of the borrowed funds then they are ahead (obviously). However, this needs to be factored into the above considerations. Note that borrowing money does not change the equity at all. So, if a company has an ROE of 20%, a Marginal ROE of 15% , interest cost of 8% and equity of $10m it could borrow $10m and the ROE would jump to 27%. (That's why raw ROE figures are only a starting point for analysis of a company). Go on - work it out for yourself - I know you can.

Alternatively, the Company could issue $10m worth of new shares (increasing the equity to $20m). In this case the ROE would fall to 13.5%. 

These are extreme examples. There are many other considerations too. Not the least being your (the investor) return on the new capital that you contribute. 

The third way for a Company to increase equity is by retaining profits. That is, by not paying out 100% of the profits in dividends. As an investor, you should apply the same considerations about ROE here as you would above. That is, is the Company using your money (the part of the earnings that they keep) effectively. If all they can think to do with the retained earnings is to put it in a bank account earning interest then it would be much better for you if they gave it to you as a dividend - if you are a good investor you should be able to do better than bank interest with the money.


However, here's something interesting.


Way back up there we noted that most often, on the share market, we don't get to buy equity at it's book value. (In the case of Cellestis we had to pay $3.27 for 24c worth of equity). That probably made you a bit jealous of the person that sold you the shares - if they were the person who bought them in the float). You, too, can buy equity at par value. Look at the following.


Take a fictional Company with the following statistics:

• Equity per share $1.00
• ROE 20%
• Marginal ROE 20%
• Share price $2.00

You might be quite happy to buy this share. After all the PE is 10. 

Let's look at what happens with the earnings. The earnings are 20c per share. The company decides to pay out 50% of the earnings as a dividend - 10c. The other 10c is retained - it adds to your equity. Now your equity is $1.10. next year because the Marginal ROE is 20%, the earnings will be 22c. Your PE has come down to 9.1. Brilliant. That's because you got to buy equity at it's real value - not the "inflated" price that you would have to pay on the share market. Of course it's likely that the market will now reprice the shares at 10 times earnings - $2.20. The 10c retained earnings that you "reinvested" is now worth 20c. Even more brilliant. 


I don't know about you, but I'd be begging the company to not pay me any dividend.

Just as with a PE, the ROE is a useful metric - it just needs to be clearly understood. 

To PE or not to PE*.

"Lab rat" comments:

Surely its necessary to mention PE ratio when talking of share price (SP). My understanding is that its difficult to know what an appropriate PE is for a company like Cellestis because it is growing so quickly and one must factor in the future expectations of the market. I am therefore wondering how people make predictions on share price. 

Not all readers of your blog have a financial/investment background and some light on this subject might be useful.

Let  me start by saying that I am no expert in these matters - just somebody who likes to think about things in a rational and logical manner. That won't stop me from espousing on the matter though.

Like all really good questions, this question doesn't have an easy answer. In fact, the answer will be different for everybody - it depends upon your own views, your own place in life and your own investment/trading aims.


In fact, this question is actually a part of a much larger (but shorter) question - How do you value a share?


If you are a Technical Analyst then you might take a totally pragmatic approach to this question and simply reply that a share is worth what the market will pay for it - now. A really hard core Technical Analyst uses only four pieces of information - Price, Volume, Time and Share Code. They don't care in the least about what the company actually does.


Good luck to them. I'm just not personally comfortable with that approach. 


(The evergreen argument of Technical Analysis (TA) vs Fundamental Analysis (FA) has been done to death over the years and holds no interest for me. In answer to the question "Which is better - TA or FA?" my answer is that it is like asking "Which is better - Football or Hot Dogs?". Both can be found at a football stadium but to trying to compare them is pointless.)


Anyway.


If we are using fundamentals to make decisions about our investments then there are many measures that we can look at - Price/Earnings (PE) is but one of them. Like all good tools, the PE can be used well and it can also be used less well. (Did I tell you about my experience of using a chisel as an emergency screwdriver?).


Mathematically, the PE is easy to calculate. It is just the SharePrice/EarningsPerShare. Expressed in plain language it would be expressed as The price that you are paying for the earnings that can be attributed to your share of the company. It is important to note that this refers to earnings within the company - not return (usually as dividend) that will be paid to you. Of course it is your hope that your earnings that are retained by the company will be used to your ultimate benefit. To deal with that issue we would need to look at Return on Equity (ROE) which I won't do here because it would distract from the simple PE discussion. (If there is any interest I will do a post on ROE at some future time).


Often the PE is defined as being the number of years that it would take for the earnings of the company to equal the price you are paying for the share. That is, a PE of 12.5 means that it will take twelve and a half years for the earnings to add up to the price you paid for the share. Whilst that is mathematically correct, I personally don't like that method of expression - but that's just me - I don't like wearing jockey shorts either.


So, we can easily calculate the PE of a Company. Alternatively, we can decide upon a PE that we would like to see and calculate a Share Price that we would be willing to pay. (SP=PE*Earnings).


How does this help us in our investing endeavours? Evidence that we can easily see tells us that PE is nowhere near the be all and end all guidance to investment choices or decisions. Just have a look at a random selection of companies listed on the ASX. You may find PEs that range from low single digits up into the hundreds. Clearly we cannot just use the PE to blindly compare investment options.


The reason for this is that, in simple terms, the share price consists of two components - a "real definable value" and a "speculative value".


Personally, If I could find a risk free investment earning 8% (that's a PE of 12.5 - work it out for yourself) then I would think that is pretty fair. You might think differently - your decision. But let's use my numbers.


Based upon the Cellestis financials for the half year ending December 2009 it works out this way. Earnings per share were about 3.3c for the half year (extrapolates to 6.6c for the full year) and the Share Price was $3.27. Using the formula above, if we wanted earnings of 8% of our investment, we would be willing to pay (6.6 *12.5) 83c per share (!).


Alternatively (and more usually) we would say that the PE of Cellestis was ($3.27/6.6c) 50. 


Clearly the additional ($3.27 - 83c) $2.44 that we would have to pay for the share if we decide to buy it is speculative or anticipatory value. That is, we would need to have faith that, in time, earnings will grow to make our investment into one that we can own up to our spouse about. For Cellestis, with the above figures, that would mean that earnings have to grow to 27c per year. (I'll come back to this)


Of course all of the above is an overcomplexified analysis of something that is really quite simple. We probably more normally just use the PE as a number to judge what the market is thinking about our potential investment. Clearly, "the market" thinks that Cellestis has a bright future. A useful thing to do with the PE is to use it to compare a company with other companies that we perceive to be similar (but perhaps at a different stage in their lives). We might discover that a cohort of companies that we consider similar to our company seem to run on a long term PE of 22. We might then assume that our Company will eventually gravitate to that PE and make some decisions accordingly. Be careful, though - it is quite easy to end up going around and around in circles (much like the "Whoopsie bird" in the film "Carry on up the Amazon" that spins around and around so fast that in the end it disappears up it's own "Whoopsie" - jeez I'm getting old). 


Now, just coming back to that $2.44 "speculative" value in the share price. Bearing in mind that "the market" is rarely right, it is our job as a potential investor to decide for ourselves if that speculative value is presenting us with a bargain. We don't want "fair" - we want a bargain.


That's when the hard work begins. We need to do the work to understand the company, it's market, it's potential, it's financials etc etc. Then we need to somehow make sense of it all. My preferred tool to bring this all together is a Discounted Cash Flow (DCF) valuation. You can read my explanation of the DCF valuation here.


* I know, they are getting worse.


** I only realised just now that that question is the same one I ask myself about 4am every morning.

Comments.

Just a note about comments.


I'm really pleased that a number of people have been adding comments to my blog. I look forward to more comments (even those that disagree with me) and am happy to foster discussion between people.


I am happy for people to post as "Anonymous" if they so wish. However, if you would prefer for your comments to be posted under your name (or alias) there are two easy ways to achieve this.

• Log in to your google (gmail) account if you have one (they're free); or
• When posting your comment select the option "Name/URL". You can then type in your name (or alias). It's not necessary to type in a URL.

Who Shot TB?*

Dallas County, Texas have been an early adopter and continuing user of QuantiFERON TB testing. Today we see this item from Dallas County.

TEXAS:   "Dallas County's Unyielding Approach on Tuberculosis Has Cases of the Disease Falling" 

Dallas Morning News     (04.15.10):: Sherry Jacobson

For the first time, the annual number of TB cases in Dallas County has fallen below 200, health officials say. In 2009, the county had 195 active TB cases, an 11 percent decline from 219 cases the previous year. 

"We're fortunate in Dallas County to have a real robust surveillance program and a public clinic working hand in hand," said Zachary Thompson, executive director of Dallas County Health and Human Services (DCHHS). 

The county's TB prevention efforts are supported by a $1.9 million budget and 60 full-time employees. 

The clinic sees 40-60 patients a day, a number including health care professionals and others screened for work and educational requirements. Ten outreach workers directly monitor the treatment of county TB patients. 

"We can meet them at a McDonald's or a 7-Eleven or a gas station," said Tesfa Kidane, who oversees the outreach workers. "Usually, a strong attachment grows between the patients and the outreach workers," Kidane said.

"It takes a very strong public health approach to keep track of the active cases," said Dr. Brian Smith, director of Region 11 for the Texas Department of State Health Services. The 19-county region, which sits mostly along the Mexico border, reported 11 TB cases per 100,000 people in 2009. 

Dallas County had 8.1 TB cases per 100,0000 last year, down from 9.2 cases in 2008. However, the county's rate is still far ahead of the national TB rate of 4.2 cases per 100,000 in 2008. The overall rate for Texas is 6.3 cases per 100,000.

Reasons for the county's and state's higher TB incidence include a large immigrant and refugee population from TB-endemic countries, experts say. 

Maybe it's a long bow to draw to assume that their adoption of QuantiFERON has contributed to their decreased rates of active TB but who knows?

*(Apologies for the title - particularly to the youngsters who were not around in the early 80's)

Don't Forget the Patients.

Amidst all this (great) financial analysis of the cost benefits of changing to QuantiFERON testing we shouldn't forget the patients.


There is a big difference between treating 56 patients and treating 7 patients with some very nasty antibiotics. 


The change to QuantiFERON is one of those true win-win situations.

• (huge) cost saving for the Health Authority
• (much) better patient outcomes.

M-I-double-S-I-double-S-I-double-P-I.

To me, the important thing about Dr. Dobbs figures is that they are real world, measurable and  accountable figures. Whilst we have seen many previous cost comparisons that factor in QALY and other esoteric long term considerations to prove the cost effectiveness of QFT over TST, it is results such as these that we see here and have seen reported from other places, such as SanFrancisco that carry the most weight.


In general, health departments work on Government style accounting which is quite different than that employed by the rest of us. They are usually funded annually and therefore make financial decisions that place much more emphasis on annual costs, rather than long term (5, 10 or more years) cost savings. 


These results show a significant (massive) cost saving over the time period of a contact investigation (about 1 year). It should therefore assist hugely in the costing part of the equation that will result in a switch to QuantiFERON testing from TST testing.

Game Over.

Have a look at this fabulous presentation by Dr. Thomas Dobbs presented at last weeks Webinar (the same one where Dr. LoBue presented.)

Ahhhh .... The Share Price.

"A1investor" says:

With so many leaks re the revised CDC guidelines, make you wonder if it will be a non event when they are released.

Might be steady as she goes until we see the next set of figures from the company.

Personally, I pretty much agree with that. Logic would make me think that anybody that is following this stock seriously would already be aware of the essential content of the CDC Guidelines and they should already be invested. However, logic (well my kind of logic, anyway) doesn't always apply to the stock market. I therefore make no prediction whatsoever about what the Share Price might do as events (such as the release of the CDC Guidelines) occur.

Of course we know that there are a whole bunch of traders out there who spend their lives trying to "second guess" each other. That's their business. It has no impact upon me. (Although I did take advantage of this weeks seller to grab a few more CST shares at a discount). 


To somebody like me (ie somebody who is only ever on the buy side of the Market Depth) the short term movements in the share price are really irrelevant. If CST runs up to $3.80 on the release of the CDC Guidelines it doesn't actually make me any richer. The chances are that even if it does then those who want to take a profit will sell their shares and the price will go down again. It's like a dog chasing it's tail. Well beyond me. I am really interested in the success of the actual business (ie sales and profits). That is what will make me richer because my dividends will go up. 


I'm wondering if we will get a profit guidance announcement in June this year as we did in 2008?


Beautiful weather at the moment. I just put new blades on my ride on and mowed all my lawns - looks a picture.

CDC Guidelines.

No, they haven't been released yet. This week? Next week? Who knows? It will happen.


Of course, thanks to the numerous presentations given by the CDC and others, we have a pretty clear picture of what the new Guidelines will contain. In essence they have recommended that there are no situations in which IGRAs cannot be used. It seems that they have noted a preference for IGRA testing in populations that have been BCG vaccinated  and in populations that have a low rate of return for TST reading. At this stage, only because of limited data, they express a preference for TST usage in children under 5 years old.


No doubt when we see the actual guidelines this detail will be fleshed out a bit more and we will be in a position to discern further nuances. 


I do note that there are those people with unrealistic expectations that are slightly disappointed that the Guidelines are not mandating a change from TST to IGRA testing. Frankly, that was never going to happen. There are far too many legal, medical and logistic hurdles to such an outcome. Even had the CDC taken such an action, logistical reasons alone would have required an extensive (many years) changeover period. That would actually have been a less than desirable result for us - it would have removed much of the imperative for swift change. Effective marketing by Cellestis will bring change at a much more rapid pace than such a scenario would have caused. 


In simple terms, the CDC are removing all shackles from the use of QFT for latent TB testing in the US. This actually brings us to a critical point in the commercial development of the Company. In my view it is now "over to Cellestis". That is, the future success of QFT in the US will be directly related to how well the Company markets it's product. There are no longer any legislative, political, technical, logistic or medical restrictions preventing Cellestis from embarking upon hard core marketing of QFT to users. 


Over the past ten years an enormous number of trials have been conducted and papers have been written. This is all evidence that QFT is superior to the incumbent TST diagnostic on all counts. It is now up to the Company to successfully turn that evidence into sales. 


I doubt that what I have said above would come as any surprise to the Company itself. Therefore, I anticipate that, subsequent to the release of the CDC Guidelines, we are going to see a far more aggressive marketing approach by the Company than we have been used to. 


It will be an enormously exciting time. Whilst we have achieved respectable sales to date, we can look forward to an acceleration of sales over the coming months and years. I would suspect that there will be a relatively immediate sales spike as those who are already convinced of the efficacy of QFT but have been awaiting the comfort of the CDC guidelines jump on board. As these authorities switch to QFT the impetus for others to change will increase. Combine this with a strong marketing exercise by the Company and we may even be surprised at how fast the change takes place.

Look Up!

Just in case you have missed it, I have added a few pages to my blog (and will add more in time). 


You can access them up the top of the page there where it says "Home", "CST Data Sheets" ....


While I'm on administration issues. Don't forget that you can subscribe to get my blog alerts by email and/or by Twitter if you are so inclined. Instructions are in that box over to the right there.


Have a great weekend.

Indeterminates? They're a bad thing, right?

Not really.


You have probably noticed that the Diel Meta Study quotes the indeterminate figure for QFT.

The pooled rate for all populations of indeterminate results was low, 2.1 percent

All this means is that in 2.1% of cases QFT was unable to provide a clear YES/NO answer to the question - "Does this patient have TB?". 


Clearly we are really after results. So, we do want as low an indeterminate rate as possible (2.1% is low, very low). However, the story does not end there. An indeterminate result is still a result - it still tells you something. It tells you that we don't know if the patient has TB - they might and they might not have.


Compare that with the currently used skin test. It has no provision for indeterminates. If it can't diagnose TB then it just gives a negative result that is indistinguishable from a true negative. This has two repercussions.


1. It may mean that patients that have potentially infectious TB may be given a (false) clean bill of health and sent off into society to possibly infect other people at some time in the future; and


2. It places all negative results from the skin test in some doubt. How do you tell the difference between a true negative and a false negative? You can't.


Neither of these situations need arise with the use of QFT. 


This whole indeterminate thing is often overlooked. 

Active?

"mongerel" writes

QUOTE

for detecting confirmed active Tuberculosis (TB) disease.

Only just noticed this after re-reading the press release. Is this a miss-print or a giant leap forward or what? 

 He is referring to the following from the Diel Meta Study 

..Interferon Gamma Release Assays (IGRAs) are superior to the previous standard in diagnostics, the 100+-year-old tuberculin skin test (TST), for detecting confirmed active Tuberculosis (TB) disease.

The reason that they use Active TB as the indicator is that there is no Gold Standard for Latent TB. That is, if you were to try to directly determine the efficacy of a new diagnostic (ie QFT-TB Gold In-tube) you would need something to measure it against. Given that there is no way to directly and correctly determine if somebody actually has latent TB* (other than the new test) then there would be no way to determine how accurate the new test is. Consequently, they use confirmed (by other methods) Active TB as a "surrogate" for latent TB.


Bear in mind that QFT-TB Gold In-Tube does not differentiate between Active and Latent TB. So, yes, QFT-TB Gold In-tube can be used to detect Active TB as well as Latent TB.


The only other way to determine if somebody has latent TB after having tested them with QFT-TB In-Tube is to not treat them and wait to see if they progress to active TB. There are obviously some ethical problems in conducting a trial in this way. However, there have been a few trials where this has been done (basically by the patient themselves electing to not have treatment). The results from these trials have also been excellent. The Halder case in the UK is a recent example of this. They found that, within 2 years, 15% of QFT positives, without treatment, progressed to active TB. 


* The fine print. There actually is one other way to determine if a patient has latent TB, In simple terms it requires the killing of the subject and dissection to find the latent TB. Understandably, it is very hard to find volunteer subjects for this type of trial.

CHEST.

By now I guess that everyone has noted that the enormously important  Diel Metasudy has been published in the latest edition of the CHEST Journal. 

The CHEST Journal is highly influential and Diel commands enormous respect in the TB field.

Acceptance Rate: between 9% and 13% since 2005

Print Circulation: 20,460

2008 Institute of Scientific Information: Journal Citation Report Data:
Impact Factor: 5.154; ranked 4th among 40 Respiratory Journals
Total Citations: 41,112; ranked 2nd among 40 Respiratory Journals
Articles: 388; ranked 3rd among 40 Respiratory Journals
Immediacy Index: 1.430; ranked 3rd among 40 Respiratory Journals
Eigenfactor Score: 0.11173; ranked 2nd among 40 Respiratory Journals
Article Influence Score: 1.516; ranked 5th among 40 Respiratory Journals

Note that this Journal article has been widely disseminated through other sources.  

This study, which determines the absolute superiority of QuantiFERON-TB Gold over all other options for latent TB testing in conjunction with the new CDC Guidelines that are to be published "any day now" places us at what will be regarded in the future as the point where QFT commenced the realization of the potential that we all knew it had.