2005, a pivotal year for Axis-Shield, with strong growth and profitability

Rarebit...Thanks for your thoughts. You appear to be hinging ultimate success/profitability on Afinion, ok there is some disappointment, but on the other hand it demonstrates the strength and breadth of Axis-Shield's product portfolio ie growth maintained 'without' Afinion. Also you do not have a good understanding of the CLIA waiver process, hopefully the read/link below will help/assist.

I am in no doubt that Afinion is a company transforming product, and therefore robustness for 'global' marketing is 'paramount', and worth the wait/delay in getting it 100% right.

Fwiw I do not think the robustness issue and CLIA waiver are actually linked, they might be linked 'internally' but not directly to the CLIA apllication, and it will be very interesting on announcement of CLIA waiver, as it appears it could serve to settle some nerves regarding Afinion and the technology employed, hence my comment pre christmas.

Provalis chose the following route to CLIA waiver -

In November 1997, the CLIA waiver provisions were revised by Congress to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver. Professional use versions of home use tests are not automatically waived. However, such professional versions do qualify for expedited waiver review since only the differences between the home use and professional use versions need to be examined to determine whether the professional version qualifies for waiver.

To summarize, under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use. -



Here is the most likely route Axis-Shield will have taken given their strive for 'global robustness'(substantially more complex and robust route), and the most 'recent' recommendation (not 1997), and reading through it will give you an understanding of why CLIA waiver takes months not weeks, and indeed why constructive discussions may arise -




It is also worthy of note that the predictive device chosen by ASD was the Bayer DCA 2000, widely accepted as an industry leader and very accurate, I believe that that in it's self was a strong show of confidence.

Further reading -



Logging off

Regards, wan