Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2020-10-06
Buyer: Sykehusinnkjøp HF
Country: NO
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 33111000: X-ray equipment | 33115100 | 38520000
Estimated value: 18655000 NOK

Technical requirements: The Medical Genetics Section has used a system for microarray delivered by Agilent since 2009. This was introduced after a tender contest was held.
In order to continue with the analysis that is currently used, we need a new scanner from Agilent that is compatible with the slides and software that is already implemented in the existing system.
Telemark Hospital would like to enter into a contract with Aglient after a voluntary ex-ante transparency notice.
The Medical Genetics Section has used a system for microarray delivered by Agilent since 2009. This was introduced after a tender contest was held. The Agilent system consists of a sample preparation kit, slides designed for copy number analysis, scanner (instrument), and analysis software (Cytogenomics). Agilent's slides consist of up to one million small DNA probes that are specifically placed for analysis in analysis software from Agilent. Agilent's scanner is the only scanner that reads the information from Agilent's slides so that their analysis software can interpret the results.
Agilent no longer guarantees new parts for the scanner in this system. In order to continue with the analysis that we currently carry out, we are dependent on replacing the scanner with the new version from Agilent, or another scanner that is compatible with Agilent's slides and analysis software. Innopsys InnoScan 910 is such a scanner, but there are no Norwegian suppliers or support in Norway.
A new directive (CE-IVDR) requires that analyses that are used for diagnostics use CE-IVD certified equipment and reagents if they are available in the market. The microarray system from Agilent is CE-IVD, but if the hospital replaces this with a scanner from another supplier, it will no longer be certified.
— interpretation of microarray analysis is demanding, and the results from the ten years that the analysis has been run are used to interpret current samples. All the results from these years are gathered in an internal database and in the analysis software Cytogenomic,
— there are other suppliers that offer microarray systems, but these are based on different technology. A lot of resources would therefore be required for the implementation and validation if another supplier is chosen, as well as the procurement of additional equipment and analysis software,
— implementation and validation will require a laboratory assistant for at least 6 months and the reagent and slides cost more. The hospital does not have the personnel resources to carry out the implementation/validation of a new system parallel to the current routine. This means that the hospital would have to supplement personnel resources or send the current samples to another laboratory,
— if the samples must be sent to another laboratory for a period of 6 months, there will be a loss of income for the section of approx. NOK 1.4 million,
— if the hospital must change to a different technology, a clinical informatics platform would also have to be procured, in order to share copy tall variants with other genetic departments (Alissa). The hospital has developed an internal database of copy tall variants from our current system, which is used to interpret current samples. It would be difficult to use this database if the hospital procures a different microarray system. The hospital would then be dependent on exchanging copy tall variants with other laboratories. This is best done via a clinical informatics platform, e.g., Alissa, which is used in medical genetics departments in other health regions,
— a clinical informatics platform must be procured and there are also costs per sample. So far Helse -Sør Øst has been in doubt as to whether such a internet based tool should be certified. It is, therefore, uncertain whether it will be possible to use such an internet based informatics platform,
— the CGH microarray platform from Agilent has functioned well in the 10 years that the hospital has used it. The system is reliable and the scanner is easy to use. The analysis results are good.
The estimated total contract value over the expected lifetime of 10 years for the equipment, including investment costs and reagents, is estimated to be
The interpretation of microarray analysis is demanding, and the results from the ten years that the analysis has been run are used to interpret the current samples. All the results from these years are gathered in an internal database and in Cytogenomic.


Winner: Agilent Dgg Norge AS
Award value: 18655000