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.
Hi Forrest,
ReplyDeleteI attempted to post your comment on the guidelines to Sharescene but it was removed by the moderator. Below is my reply to your comment as posted to that discussion board:
While its true that Cellestis should continue to market and market aggressively now that the CDC has removed the "shackles" I think that it should be noted that leaders in the USA TB control community are doing a pretty good job of marketing QFT.
For instance, the Francis J. Curry National Tuberculosis Center provides web-based learning modules for practitioners including one by Dr. L. Masae Kawamura (Director and TB Controller for the City and County of San Francisco Department of Health and also serves as the principal investigator for the Regional TB Training and Medical Consultation Center). Dr K's presentation specifically discusses "the role of Interferon Gamma Release Assays (IGRAs) as diagnostic tools for latent TB infection (LTBI)". In the presentation, Dr K. comments that IGRAs (i.e.QFT) will effectively replace the TB skin test and predicts that the skin test will become "a secondary test reserved for special situations" (audio commentary with slide #38).
This kind of marketing will always trump anything that a company can offer and is invaluable in its influence on health administrators and practitioners.
Everything is in place now for an increased acceleration in sales. Roll on 2010-2011!
http://www.nationaltbcenter.ucsf.edu/testi...resentation.cfm
Puzzled
G'day Puzzled,
ReplyDeleteThanks for your comment.
I agree totally with you. Utilizing that resource (the TB Community) is an important part of the Marketing process.
I certainly don't want to imply that the company will (or should) embark upon employing slick haired, knock on doors salesmen. That is obviously not appropriate in this market.
With an extensive laboratory network already in place and the green light of the CDC Guidelines, appropriate marketing should result in impressive sales growth.
As to Sharescene moderation policies - I would prefer not to comment.
Greetings Forrest,
ReplyDeleteI agree with your well reasoned comments viz CDC guidelines.The gradual roll out of the IT in Japan will have a good effect on the bottom line as will the sales in the US expand when the cost savings per test candidate are recognised by State health providers.
For what it is worth I have always enjoyed reading your comments and opinions,keep up the good work.
Love the Bird
Thanks for your kind comments, tasman seabird.
ReplyDeleteYes, Japan should hopefully provide a fillip to sales figures for this half. We know that, because of the documentation problem, sales of In-Tube did not commence until this half and, consequently, stocks of "gold" in Japan were run out.
Exciting times!
This comment has been removed by a blog administrator.
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