Axis-shield Share Discussion Threads

[rarebit] 07/1/2011 10:46

Yep, totally agree with you too, cumnor.

We can't go on waiting for ever.

My expectation is that the tide will turn, but as wan points out, it has to turn soon otherwise the advantage Afinion currently has will be lost. When Gillham succeeded Svein, he emphasised that ASD were at a new stage in their evolution - that of commercialisation. My impression is that they are making real efforts to deliver profits / dividends, but until shareholders actually see some returns my instinct is that the share price will languish. Too many people (Mr Slaterlp included) have become disillusioned by the bread today jam tomorrow mentality of the Board.

Rarebit

[hotfinance14] 07/1/2011 10:40

I speak to Ian Gillham often and he is certainly on the ball. I am confident he will deliver.

[cumnor] 07/1/2011 10:29

Rarebit, agree but if Mr Gilham does'nt deliver on what is the important bit, profit and shareholder value then the bod should imo consider his position. With it's unique products there is no reason whatsoever why ASD's mrkt cap should not be multiples of what it is at present. imo dyor

[rarebit] 07/1/2011 09:58

Good news: AXIS-SHIELD SIGNS OPTION AGREEMENT WITH BIO-RAD LABORATORIES INC. FOR COMMERCIALISATION OF HEPARIN BINDING PROTEIN MARKER

[rarebit] 07/1/2011 09:42

Pre-close trading update on Monday (10th Jan).

Did they meet their Afinion target?
Will a dividend be announced?

Rarebit

[hotfinance14] 30/12/2010 15:33

ASD was tioppen in Shares magazine last week.They believe the continued success of Affinion could possibly make them a takeover play.

[24jp] 24/12/2010 08:24

2010 was a bad year for ASD, but 2011 is going to be avery good year indeed.

Now all the bad news is out of the way, there is nothing to stop the share price regaining the plus 300 mark. This will happen quite quickly and a wise investor would buy this stock whilst it is so heavily discounted.

I see 300 plus BEFORE Easter 2011.

BUY BUY BUY

[slaterlp] 24/12/2010 08:07

And so to sum up.

ASD managements are big on promises, and VERY small on delivery.

Ho hum. same ole same ole.

2011 will be just the same for ASD as 2010. Pants.

If this stock sees 300 this side of 2012, it will be a true miracle.

[wan] 23/12/2010 16:57

Rarebit...Well in my opinion only, it was not fair to imply that the ACR market is small and therefore it don't matter a whole lot. But I think I got my pount across.

I actually hope you are right, but if just a tweak is required, why has it taken this long to be denied when ASD were obviously in discussion with the FDA, and surely a tweaked re-submission could have already been made by now. That aside, the CEO said "we believe the Afinion(TM) test for this parameter can meet the requirement for a degree of simplicity which will minimalise risk of error". Well as I highlighted, a degree of simplicity is not what I understand as being enough. Here is exactly what The Centers for Medicare & Medicaid Services (CMS) says, they regulate all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). -

WHAT IS A WAIVED TEST?
As defined by CLIA, waived tests are categorized as "simple laboratory examinations and procedures that have an insignificant risk of an erroneous result."
You will perhaps appreciate my scepticism, as these requirments do not align with the CEO's description. I genuinely wish you the best of luck though.


Regards

Wan

[rarebit] 23/12/2010 14:23

wan,

Don't disagree with alot of what you've said. I agree it would be 'very' disappointing if CLIA waiver wasn't obtained for the ACR test. Where we differ is on our reading of the statement. My clear impression is that all that is required is a 'tweak'.

If I'm wrong, then I believe the statement is wholly misleading. As it stands, I look forward to news of a re-submission for CLIA waiver within a few months, and the grant of a licence within a year at most.

Rarebit

[wan] 23/12/2010 07:13

Rarebit...I don't want to get drawn into an in-depth debate here, but let me qualify my comment with a bit more detail and put the disappointment into better perspective than perhaps ASD did. And at the same time note why I am surprised one analyst described it as "not material in the grand scheme of things" (see my comment regarding facilities with a CLIA Certificate of Waiver further below). Also, would you agree with the analyst's claim that "Axis-Shield had flagged well in advance that it would probably not get the CLIA waiver"?

First of all and in layman's terms (because that is how best I understand things), let's start with what is the criteria for a test to be CLIA waived. Basically it means that a device/test is not capable of giving erroneous results via user operation, or at least the risk of such is insignificant. For instance, apart from taking a sample of blood and entering this into a cartridge and the cartridge into the device, there is no other user input or assessment necessary to arrive at the test result.

The Siemens (formerly Bayer) DCA 2000 ACR test has been in existence since 1996, it is classified as moderately complex and widely recognised as not being able to achieve CLIA waiver. Moderately complex was also how Afinion's ACR test was classified prior to the application for CLIA waived status, and now of course remains as such. Given then that it should have been relatively obvious what was required i.e. simplicity, and in fact the test procedure for the Afinion ACR test appears to be nothing more than simple –

you have to wonder why it did not achieve CLIA waived status, but my guess is that the resolution necessary to achieve it might be a bit more involved than just a tweak, especially given how long it has taken already.

Why was ACR worth putting on Afinion? Well it is another important test in the management of diabetes because diabetics are at high risk from developing kidney disease, but it is not fair for the CEO to simply say "The market for ACR testing in diabetes is relatively small compared to HbA1c monitoring". It's smaller that HbA1c for two reasons, in the management of diabetes it is recommended that ACR is tested at 'least' once a year (compared to four for HbA1c), but the other important reason it is small is because it is not CLIA waived, whereas HbA1c is CLIA waived. Hence my point, that CLIA waiver would have almost certainly increased the use of ACR, and perhaps by quite a large amount.

To demonstrate why I think there could have been an increase in use you first have to appreciate that if a doctor wants to perform a CLIA waived test then each of his offices( where testing takes place) must have a CLIA Certificate of Waiver. When I last checked there were approximately 80 CLIA waived tests (and a multitude of manufacturers for each i.e. glucose). The notable point though is that there are approximately 80,000 CLIA-accredited facilities in the US, but not of all of these will want to use Afinion to test for ACR (being full blown labs etc) and a much lower percentage of those facilities will be the doctor's office/lab that is classified as a CLIA-accredited facility, hence Axis-Shield statement that physicians will still be able to test ACR at the point of care in the US. But you get the picture as to why it is being passed off as small. However, if we include the number of facilities with a CLIA Certificate of Waiver, then the number of facilities able to perform a CLIA test increases by approximately 120,000 (a total of approximately 200,000 enrolled facilities). In other words, the lion's share of CLIA waived testing is carried out at facilities with a CLIA Certificate of Waiver; hence ACR was worth putting on Afinion, and thus any test should benefit from achieving CLIA waived status.

The problem I have is that the disappointment (regarding Afinion) is compounded by the previous shelving of the PT-INR test, after years of promising the introduction of the test, and I also note that CRP 510K is taking a long time too. Surely from a sales perspective, prospective buyers might start doubting how expandable the menus of tests are and whether Axis-Shield can deliver. One might also speculate as to why Abbott was prepared to sell back the US rights if it was such a compelling device?

In my opinion, Axis-Shield had a technological lead in Afinion, but they have failed to capitalise on it. The years wasted on the PT-INR test could have meant that the lucrative lipid panel and hsCRP tests could have been developed and successfully launched (I did have that conversation with management years ago). It appears they have realised this late in the day, and are now having to run to keep up with the ever increasing competition, not to mention the increasingly embedded installed base of large players, such as Cholestech's LDX which is CLIA waived for 7 out of their 8 tests (Cholestech was bought by Inverness Medical, now rebranded Alere) –


Although I sold out of Axis-Shield, I still wanted to keep an investment that was exposed to the medical sector and in particular the POC sector. So I used the proceeds to increase my holding in Carclo (CAR), who's sales to the medical sector and POC sector have been growing strongly, and also in another company with management that has an enviable track record in the medical diagnostics and POC sector, and include the dynamic duo Julian Baines and David Evans, the company is called EKF Diagnostics (EKF). I believe that EKF will be a serious player and competitor in the POC sector –
And arguably in a far higher risk investment in Avacta (take a look at their up and coming POC platform, currently launching into the veterinary market)


Of course Axis-shield is doing ok, but the management have a lot of work to do to regain the status they once had, and this set back has certainly not helped that case. I do keep an eye on them and perhaps one day they will regain my attention and admiration.

The above is only my own opinion and thoughts, so I could be either wrong or inaccurate, so please conduct your own research to form any investment decisions etc.

Regards

Wan

[hotfinance14] 22/12/2010 13:52

He is the Wan...i mean the Man.

[rarebit] 22/12/2010 13:46

Blimey !!!!!!

Wan is quoted in newspaper articles !!!!!!!!!!!!!!!!!!!!!!

[scobiebreasley] 22/12/2010 10:59

Chris Glasper, director of equity research at Brewin Dolphin, nevertheless said the latest announcement was not particularly serious.

"It's a minor setback and not great for sentiment in the short term, but it's not material in the grand scheme of things," he said.

"Axis Shield had flagged well in advance that it would probably not get the CLIA waiver. It has been going on for two years and approval was not factored in to analysts' forecasts."

[rarebit] 22/12/2010 09:39

wan,

Disappointing, granted.

But let's keep this in perspective. No other ACR test has been CLIA waived, and the parameters for achieving that status had never been defined by the FDA. This was (so management told us) the fundamental reason for the long delay in processing the application. In the absence of any benchmark standard (or competing test to compare with), ASD had to do their best to 'guess' what was required. They now know and, I suspect from the bullish nature of the announcement, are confident of meeting the requirements.

The situation with the lipid panel of tests is entirely different. Other tests have been CLIA waived and ASD know exactly what is required to achieve the status. As a consequence, both they and the FDA know what they are doing, and they anticipate the lipid application will be processed far, far quicker. If CLIA waiver wasn't achieved for the lipid panel of tests, that WOULD be VERY disappointing.

Conversely, this is a minor hiccup.

Happy Christmas to all!
Here's hoping (blindly perhaps ....) that 2011 is good to ASD !!!

Rgds
Rarebit

[slaterlp] 21/12/2010 13:49

200 before xmas? ho ho ho.

Happy christmas.

[shroder] 21/12/2010 10:35

800k traded, that's a fair bit for ASD - hopefully this will take care of the persistent overhang which has been around for an age.

[wan] 21/12/2010 07:30

Although I am no longer invested here (due to missed growth forecasts and poor communication) I feel compelled to comment on today's news.

Today's announcement of not achieving CLIA waiver on the Afinion ACR is very disappointing. I note that management are dressing up ACR use as only being a relatively small business and thus the decision will not materially impact on forecasted sales (one could ask why include it on Afinion and pursue CLIA Waiver then?). However, CLIA waived status would of a) almost certainly resulted in an increase in use (perhaps a large increase) and more importantly b) would of course been an important differentiator to the Siemens DCA 2000, which is proving to provide stiff competition. So, once again it is the growth that is in question, and that is why ASD had original attractions, that attraction factor is looking less than compelling.

[hotfinance14] 20/12/2010 10:35

I must know over 50 people myself that have Flu...even David Haye has it.

[hotfinance14] 17/12/2010 08:43

Peel Hunt are the new ASD corporate broker and advisor.

[gerd212] 16/12/2010 09:38

magandang gabi

[shroder] 14/12/2010 14:13

I have a feeling it was shorted down knowing they maybe looking to fund this acquisition, could be either though I guess.

[drmac] 14/12/2010 01:23

wan are you still around?
You always had a wealth of knowledge about the shares you invested in!
Don