Markedshøring Oncotype DX

Region Zealand is assisting the Danish Health Technology Council in conducting a market consultation about the existence of any CE marked non-invasive prognostic test to guide adjuvant chemotherapy treatment decisions for individuals with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), early-stage (I-IIIa) invasive breast cancer. The test …

CPV: 38432000 Aparatos de análisis, 38434520 Analizadores de sangre, 85111810 Servicios de análisis de sangre, 85148000 Servicios de análisis médicos
Lugar de ejecución:
Markedshøring Oncotype DX
Organismo adjudicador:
Region Sjælland
Número de premio:
2025-01-17

1. Buyer

1.1 Buyer

Official name : Region Sjælland
Legal type of the buyer : Regional authority
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : Markedshøring Oncotype DX
Description : Region Zealand is assisting the Danish Health Technology Council in conducting a market consultation about the existence of any CE marked non-invasive prognostic test to guide adjuvant chemotherapy treatment decisions for individuals with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), early-stage (I-IIIa) invasive breast cancer. The test provides two pieces of information: 1. the recurrence risk and 2. the benefit of adding chemotherapy in order to reduce the risk. The test analyses the expression of 21 genes in breast tumour tissue based on RT-PCR. It does not require additional tumour material beyond the surgically excised tissue. This is the case because a company has requested the Danish Health Technology Council to assess their non-invasive prognostic test to guide adjuvant chemotherapy treatment decisions for individuals with HR+, HER2-, I-IIIa invasive breast cancer.
Internal identifier : 2025-01-17

2.1.1 Purpose

Main nature of the contract : Supplies
Additional nature of the contract : Services
Main classification ( cpv ): 38434520 Blood analysers
Additional classification ( cpv ): 38432000 Analysis apparatus
Additional classification ( cpv ): 85111810 Blood analysis services
Additional classification ( cpv ): 85148000 Medical analysis services

2.1.2 Place of performance

Country : Denmark
Anywhere in the given country

2.1.4 General information

Legal basis :
Directive 2014/24/EU

3. Part

3.1 Part technical ID : PAR-0000

Title : Markedshøring Oncotype DX
Description : Region Zealand is assisting the Danish Health Technology Council in conducting a market consultation about the existence of any CE marked non-invasive prognostic test to guide adjuvant chemotherapy treatment decisions for individuals with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), early-stage (I-IIIa) invasive breast cancer. The test provides two pieces of information: 1. the recurrence risk and 2. the benefit of adding chemotherapy in order to reduce the risk. The test analyses the expression of 21 genes in breast tumour tissue based on RT-PCR. It does not require additional tumour material beyond the surgically excised tissue. This is the case because a company has requested the Danish Health Technology Council to assess their non-invasive prognostic test to guide adjuvant chemotherapy treatment decisions for individuals with HR+, HER2-, I-IIIa invasive breast cancer.
Internal identifier : 2025-01-17

3.1.1 Purpose

Main nature of the contract : Supplies
Additional nature of the contract : Services
Main classification ( cpv ): 38434520 Blood analysers
Additional classification ( cpv ): 38432000 Analysis apparatus
Additional classification ( cpv ): 85111810 Blood analysis services
Additional classification ( cpv ): 85148000 Medical analysis services

3.1.2 Place of performance

Country : Denmark
Anywhere in the given country

3.1.5 General information

Reserved participation : Participation is not reserved.
The procurement is covered by the Government Procurement Agreement (GPA) : yes
This procurement is also suitable for small and medium-sized enterprises (SMEs)

3.1.6 Procurement documents

Deadline for requesting additional information : 13/01/2025 11:00 +00:00

3.1.7 Terms of procurement

The execution of the contract must be performed within the framework of sheltered employment programmes : No

3.1.9 Further information, mediation and review

Review organisation : Klagenævnet for Udbud
Organisation providing information concerning the general regulatory framework for taxes applicable in the place where the contract is to be performed : Konkurrence- og Forbrugerstyrelsen
Organisation providing information concerning the general regulatory framework for environmental protection applicable in the place where the contract is to be performed : Konkurrence- og Forbrugerstyrelsen
Organisation providing information concerning the general regulatory framework for employment protection and working conditions applicable in the place where the contract is to be performed : Konkurrence- og Forbrugerstyrelsen
Organisation providing additional information about the procurement procedure : Region Sjælland
Organisation providing offline access to the procurement documents : Region Sjælland
Organisation providing more information on the review procedures : Klagenævnet for Udbud

8. Organisations

8.1 ORG-0001

Official name : Region Sjælland
Registration number : 29190658
Department : Koncern Indkøb
Postal address : Alleen 15
Town : Sorø
Postcode : 4180
Country subdivision (NUTS) : Vest- og Sydsjælland ( DK022 )
Country : Denmark
Contact point : Michael Lehmann Nielsen
Telephone : +45 51647577
Roles of this organisation :
Buyer
Organisation providing additional information about the procurement procedure
Organisation providing offline access to the procurement documents

8.1 ORG-0002

Official name : Klagenævnet for Udbud
Registration number : 37795526
Postal address : Nævnerens Hus, Toldboden 2
Town : Viborg
Postcode : 8800
Country subdivision (NUTS) : Vestjylland ( DK041 )
Country : Denmark
Telephone : +45 72405600
Internet address : http://www.klfu.dk
Roles of this organisation :
Review organisation
Organisation providing more information on the review procedures

8.1 ORG-0003

Official name : Konkurrence- og Forbrugerstyrelsen
Registration number : 10294819
Postal address : Carl Jacobsens Vej 35
Town : Valby
Postcode : 2500
Country subdivision (NUTS) : Københavns omegn ( DK012 )
Country : Denmark
Telephone : +45 41715000
Internet address : http://www.kfst.dk
Roles of this organisation :
Organisation providing information concerning the general regulatory framework for taxes applicable in the place where the contract is to be performed
Organisation providing information concerning the general regulatory framework for environmental protection applicable in the place where the contract is to be performed
Organisation providing information concerning the general regulatory framework for environmental protection applicable in the place where the contract is to be performed

8.1 ORG-0004

Official name : Mercell Holding ASA
Registration number : 980921565
Postal address : Askekroken 11
Town : Oslo
Postcode : 0277
Country subdivision (NUTS) : Oslo ( NO081 )
Country : Norway
Contact point : eSender
Telephone : +47 21018800
Fax : +47 21018801
Internet address : http://mercell.com/
Roles of this organisation :
TED eSender

11. Notice information

11.1 Notice information

Notice identifier/version : 8bf13298-7d54-45d6-87b2-c2428e451e41 - 01
Form type : Planning
Notice type : Prior information notice or a periodic indicative notice used only for information
Notice dispatch date : 19/12/2024 15:22 +00:00
Notice dispatch date (eSender) : 20/12/2024 11:00 +00:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00790159-2024
OJ S issue number : 249/2024
Publication date : 23/12/2024
Estimated date of publication of a contract notice within this procedure : 31/12/2025