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Portable and accurate PSA test
No special training is required and the system is small enough to be used in any location. Place the PSAwatch™ cassette into the Bioscan™ reader, put the sample into the “test well” and wait 10 minutes for the PSA result.
The test is clinically equimolar with NIBSC and European standards and correlates well with a standard laboratory assay (R2=0.88) [1]. The test works with whole blood from a venous puncture or finger-prick, and plasma [2].
Urologists, primary care physicians and nurses rely on accurate measurement of PSA for the management of new or recurrent prostate disease.
The PSAwatch system measures PSA to one decimal place, in the clinically significant range (0.5 - 25µg/l)
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Comment by 5thString on March 28, 2009 at 7:56pm -
Just an update in that Inverness Medical Innovations have signed a five-year agreement for the
worldwide distribution of PSAwatch as of 16 March 2009.
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Comment by 5thString on March 15, 2009 at 9:18pm
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PSAwatch is CE approved and is going through the ever lasting FDA approval route which should be gained sometime this year.If you require any further information regarding this device then I can post what I have or I'm sure the company would be more than happy to talk to you.
"CE approval was obtained for PSAwatch in February 2008 and the product was officially launched at the British Association of Urological Surgeons (BAUS) annual meeting in June 2008. As a result of steady marketing we are generating significant global interest in this product. We are also running clinical trials and collaborating with several prostate cancer awareness patient groups around the world.
Manufacturing of the test strip has been contracted to British Biocell International Limited, a division of Inverness Medical Innovations, Inc. We anticipate this arrangement will allow us a scalable manufacturing agreement and the flexibility to meet future demand.
FDA Approval Process - clinical trials are now well underway at one site in the USA and two sites in the UK. We anticipate that the results will be presented to the FDA Board during the first half of 2009. We will inform the market when we have further progress to report."
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Comment by E. Michael D. ("Mike") Scott on March 15, 2009 at 8:44pm -
Mick:
Is this device approved in the whole of Europe or just in the UK?
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