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NORDIAG CE IVD LABELS ITS ARROW STOOL KIT AND BULLET VIRAL KIT
NorDiag continues to expand its portfolio of sample preparation kits for diagnostic purposes. Today the Company announces that its Arrow Stool Kit and its Bullet Viral Kit are available for in vitro diagnostics (IVD) use in Europe. Clinical laboratories in Europe will now be able to use the kits for clinical purposes.
"CE IVD (In Vitro Diagnostics) labeling is a growth driver by increasing the revenues per instrument sold and opens up for new instrument sales. CE IVD marking enables sales to diagnostics laboratories and facilitates sales to several more customers. As the number of kits increases, the laboratories will be able to use the NorDiag kits towards a increased numbers of diagnostic tests.", explains Mårten Wigstøl, CEO in NorDiag, and continues:
"The Bullet instrument was CE IVD marked in 2009. We announced recently CE IVD marking of our Arrow instrument as well as CE IVD marking of kits for both the Arrow and Bullet instruments. We have now three CE marked sample preparation kits for the Arrow and there is one more kit (Viral) in progress. Furthermore, we have two sample preparation kits for the Bullet and there is one more kit (Blood) in progress"
The CE IVD labeling of NorDiag's Stool Kit (for the Arrow instrument) and Viral Kit (for the Bullet instrument) comes after successful completion of validation studies.
The Arrow Stool Kit
The Arrow Stool Kit is a sample preparation kit that can be applied for testing of viruses and bacteria where stool is used as the sample type. Examples of such diseases are clostridium difficile, diarrhea and stomach ulcer.
The introduction of the Arrow Stool Kit expands our product portfolio. Our customers can use three to four kit variants to cover several applications and/or diseases. This simplifies the laboratory processes and increases ease of use. Multiple uses of applications on the same instrument platform are a growth driver since it increases NorDiag's reagent revenue per instrument as well as opens up for new instrument sales. The kit can be used with the majority of DNA based tests using stool as sample material.
"NorDiag expects good progress with respect to sale of Arrow instruments and kits in this market", Wigstøl comments.
NorDiags desk top and low throughput instrument Arrow has the capacity of up to 10 000 isolations per year. It has a very attractive price which enables many laboratories and hospitals to buy the instrument without a tender offering process.
The Bullet Viral Kit
The Bullet Viral Kit is a sample preparation kit which can be applied for testing of virus infections, such as influenza A, B and H1N1 (swine flu).
"The Bullet Viral Kit is a key element for successful sales of Bullet instruments in the viral segment of the infectious disease market. The kit can be used with the majority of DNA based virus tests used in this market. NorDiag can now offer a set of IVD sample preparation kits for its Bullet instrument covering both viruses and bacteria. It is the applications and its flexibility that drives the instrument sales, and as such NorDiag now has a very good strategic position for its Bullet instrument in the infectious disease market", Wigstøl comments.
NorDiags medium/high throughput instrument Bullet has the capacity of up to 100 000 isolations per year.
Contact:
CEO Mårten Wigstøl - Phone. +47 911 65775
Read the notice in Norwegian here.