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

All...According to my research and in my opinion only, ASD’s focus on automatic calibration is bang on the money, which I think is all about QC in the field, or more to the point, the ‘frequency’ of QC. If my understanding is correct, CLIA waived sites must adhere to the manufacturer’s testing instructions, those ‘required’ instructions contain what aspects of the test system are monitored by QC procedures and provides instructions on how to perform QC and importantly Includes recommendations on how frequently QC should be performed. In other words, Internal, procedural, or built-in controls reduce the required frequency of running external liquid controls to the minimum, which in turn results in less paper work, which importantly reduces operating costs via the external liquid controls covering a larger number of actual tests in a shipment/lot number and of course time. In short, less QC equates to competitive costs for the end user and subsequently much wider appeal.

Although Afinion is a global product it should be remembered that it was specifically designed for the US market, hence the focus? The following is perhaps essential reading, which I have previously posted, and is worth reading to see how I arrived at my assessment, particularly EQC option 4 in the last two paragraphs (not to mention option 1 in table 1 at the beginning) and is perhaps ‘pivotal’ in Axis-Shield’s particular focus given that the process for developing EQC option 4 is already under way? -

EQC option 4 -
A manufacturer performs a scientifically rigorous risk assessment and validates a QC procedure that will provide substantial equivalence to traditional QC.

The manufacturer submits the validation data to FDA using existing submission processes. FDA reviews and approves the proposed QC procedure if the validation data are considered sufficient.

Laboratories will be allowed to use the alternative QC protocol in place of the CLIA-mandated QC requirements for that assay. -





The successful implementation of option 4 could make certain other tests appear archaic, if not obsolete! So lets not loose our ‘focus’ on such overstatements of disappointment that CLIA waiver having not yet been attained, and the above may also help to further explain the 'constructive discussions', or as described by the Nomura analyst, CLIA waiver is under negotiation?

It may also put an additional slant on why Provalis arguably rushed their system out (with disastrous results), ie not just superior competition from Afinion but a higher expectation from the market place post option 4 and a more challenging environment regarding CLIA waiver and QC?