{"bekendtgoerelseNoegle":{"noticeId":{"value":"8bf13298-7d54-45d6-87b2-c2428e451e41"},"noticeVersion":{"value":"01"},"noticePublicationNumber":{"value":"00790159-2024"}},"htmlDA":"\n\n \n
1 Køber
1.1 Køber
Officielt navn: Region Sjælland
\n
Køberens retlige status: Regional myndighed
\n
Den ordregivende myndigheds aktiviteter: Sundhed
\n
\n
\n
2 Procedure
2.1 Procedure
Titel: Markedshøring Oncotype DX
\n
Beskrivelse: Region Zealand is assisting the Danish Health Technology Council in conducting a market\n consultation about the existence of any CE marked non-invasive prognostic test to\n guide adjuvant chemotherapy treatment decisions for individuals with hormone receptor-positive\n (HR+), human epidermal growth factor receptor 2-negative (HER2-), early-stage (I-IIIa)\n invasive breast cancer. The test provides two pieces of information: 1. the recurrence\n risk and 2. the benefit of adding chemotherapy in order to reduce the risk. The test\n analyses the expression of 21 genes in breast tumour tissue based on RT-PCR. It does\n not require additional tumour material beyond the surgically excised tissue. This\n is the case because a company has requested the Danish Health Technology Council to\n assess their non-invasive prognostic test to guide adjuvant chemotherapy treatment\n decisions for individuals with HR+, HER2-, I-IIIa invasive breast cancer.
\n
Intern identifikator: 2025-01-17
\n
2.1.1 Formål
Kontraktens art: Varer
\n
Yderligere om kontraktens art: Tjenesteydelser
\n
Primær klassificering (cpv): 38434520 Blodanalyseapparater
\n
Yderligere klassificering (cpv): 38432000 Analyseapparatur
\n
Yderligere klassificering (cpv): 85111810 Blodanalysetjenester
\n
Yderligere klassificering (cpv): 85148000 Medicinske analyser
\n
\n
2.1.2 Udførelsessted
Land: Danmark
\n
Hvor som helst i det pågældende land
\n
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2.1.4 Generelle oplysninger
Retsgrundlag:
\n
Direktiv 2014/24/EU
\n
\n
\n
\n
3 Del
3.1 Del: PAR-0000
Titel: Markedshøring Oncotype DX
\n
Beskrivelse: Region Zealand is assisting the Danish Health Technology Council in conducting a market\n consultation about the existence of any CE marked non-invasive prognostic test to\n guide adjuvant chemotherapy treatment decisions for individuals with hormone receptor-positive\n (HR+), human epidermal growth factor receptor 2-negative (HER2-), early-stage (I-IIIa)\n invasive breast cancer. The test provides two pieces of information: 1. the recurrence\n risk and 2. the benefit of adding chemotherapy in order to reduce the risk. The test\n analyses the expression of 21 genes in breast tumour tissue based on RT-PCR. It does\n not require additional tumour material beyond the surgically excised tissue. This\n is the case because a company has requested the Danish Health Technology Council to\n assess their non-invasive prognostic test to guide adjuvant chemotherapy treatment\n decisions for individuals with HR+, HER2-, I-IIIa invasive breast cancer.
\n
Intern identifikator: 2025-01-17
\n
3.1.1 Formål
Kontraktens art: Varer
\n
Yderligere om kontraktens art: Tjenesteydelser
\n
Primær klassificering (cpv): 38434520 Blodanalyseapparater
\n
Yderligere klassificering (cpv): 38432000 Analyseapparatur
\n
Yderligere klassificering (cpv): 85111810 Blodanalysetjenester
\n
Yderligere klassificering (cpv): 85148000 Medicinske analyser
\n
\n
3.1.2 Udførelsessted
Land: Danmark
\n
Hvor som helst i det pågældende land
\n
\n
3.1.5 Generelle oplysninger
Reserveret deltagelse: Deltagelse uden forbehold.
\n
Udbuddet er omfattet af aftalen om offentlige udbud (GPA): ja
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Dette udbud er også egnet for små og mellemstore virksomheder (SMV'er)
\n
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3.1.6 Udbudsdokumenter
Adresse på udbudsdokumenterne: https://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=419895&B= ,
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Frist for anmodning om yderligere oplysninger: 13-01-2025 11:00 +00:00
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3.1.7 Udbudsvilkår
Udførelsen af kontrakten skal ske inden for rammerne af programmer for beskyttet beskæftigelse: Nej
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3.1.9 Yderligere oplysninger, mægling og gennemgang
Organisation med ansvar for klager: Klagenævnet for Udbud
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Organisation, der leverer oplysninger om den generelle lovgivningsramme på det sted, hvor kontrakten skal udføres, hvad angår skatter: Konkurrence- og Forbrugerstyrelsen
\n
Organisation, der leverer oplysninger om den generelle lovgivningsramme på det sted, hvor kontrakten skal udføres, hvad angår miljøbeskyttelse: Konkurrence- og Forbrugerstyrelsen
\n
Organisation, der leverer oplysninger om den generelle lovgivningsramme på det sted, hvor kontrakten skal udføres, hvad angår sikkerhed på arbejdspladsen og arbejdsvilkår: Konkurrence- og Forbrugerstyrelsen
\n
Organisation, der leverer supplerende oplysninger om udbudsproceduren: Region Sjælland
\n
Organisation, der sikrer adgang til udbudsdokumenterne offline: Region Sjælland
\n
Organisation, der leverer yderligere oplysninger om klageprocedurerne: Klagenævnet for Udbud
\n
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8 Organisationer
8.1 ORG-0001
Officielt navn: Region Sjælland
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Registreringsnummer: 29190658
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Afdeling: Koncern Indkøb
\n
Postadresse: Alleen 15  
\n
By: Sorø
\n
Postnummer: 4180
\n
Landespecifik underafdeling (NUTS): Vest- og Sydsjælland (DK022)
\n
Land: Danmark
\n
Kontaktpunkt: Michael Lehmann Nielsen
\n
E-mail: michaeni@regionsjaelland.dk
\n
Telefon: +45 51647577
\n
Køberprofil: https://eu.eu-supply.com/ctm/company/companyinformation/index/137394
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Denne organisations roller:
Køber
\n
Organisation, der leverer supplerende oplysninger om udbudsproceduren
\n
Organisation, der sikrer adgang til udbudsdokumenterne offline
\n
\n
\n
8.1 ORG-0002
Officielt navn: Klagenævnet for Udbud
\n
Registreringsnummer: 37795526
\n
Postadresse: Nævnerens Hus, Toldboden 2  
\n
By: Viborg
\n
Postnummer: 8800
\n
Landespecifik underafdeling (NUTS): Vestjylland (DK041)
\n
Land: Danmark
\n
E-mail: klfu@naevneneshus.dk
\n
Telefon: +45 72405600
\n
Internetadresse: http://www.klfu.dk
\n
Denne organisations roller:
Organisation med ansvar for klager
\n
Organisation, der leverer yderligere oplysninger om klageprocedurerne
\n
\n
\n
8.1 ORG-0003
Officielt navn: Konkurrence- og Forbrugerstyrelsen
\n
Registreringsnummer: 10294819
\n
Postadresse: Carl Jacobsens Vej 35  
\n
By: Valby
\n
Postnummer: 2500
\n
Landespecifik underafdeling (NUTS): Københavns omegn (DK012)
\n
Land: Danmark
\n
E-mail: kfst@kfst.dk
\n
Telefon: +45 41715000
\n
Internetadresse: http://www.kfst.dk
\n
Denne organisations roller:
Organisation, der leverer oplysninger om den generelle lovgivningsramme på det sted, hvor kontrakten skal udføres, hvad angår skatter
\n
Organisation, der leverer oplysninger om den generelle lovgivningsramme på det sted, hvor kontrakten skal udføres, hvad angår miljøbeskyttelse
\n
Organisation, der leverer oplysninger om den generelle lovgivningsramme på det sted, hvor kontrakten skal udføres, hvad angår miljøbeskyttelse
\n
\n
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8.1 ORG-0004
Officielt navn: Mercell Holding ASA
\n
Registreringsnummer: 980921565
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Postadresse: Askekroken 11  
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By: Oslo
\n
Postnummer: 0277
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Landespecifik underafdeling (NUTS): Oslo (NO081)
\n
Land: Norge
\n
Kontaktpunkt: eSender
\n
E-mail: publication@mercell.com
\n
Telefon: +47 21018800
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Fax: +47 21018801
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Internetadresse: http://mercell.com/
\n
Denne organisations roller:
TED eSender
\n
\n
\n
\n
11 Oplysninger om bekendtgørelsen
11.1 Oplysninger om bekendtgørelsen
Identifikator for bekendtgørelsen: 8bf13298-7d54-45d6-87b2-c2428e451e41 - 01
\n
Formulartype: Planlægning
\n
Bekendtgørelsestype: Forhåndsmeddelelse eller vejledende periodisk bekendtgørelse, der kun er anvendt til informationsformål
\n
Afsendelsesdato for bekendtgørelsen: 19-12-2024 15:22 +00:00
\n
Dato for afsendelse af bekendtgørelse (eSender): 20-12-2024 11:00 +00:00
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Sprog, som denne bekendtgørelse er officielt tilgængelig på: engelsk 
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\n
11.2 Oplysninger om offentliggørelsen
Bekendtgørelsesnummer: 00790159-2024
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EUT-S-nummer: 249/2024
\n
Offentliggørelsesdato: 23-12-2024
\n
Den påtænkte dato for offentliggørelse af en udbudsbekendtgørelse inden for denne procedure: 31-12-2025
\n
\n
\n \n","htmlEN":"\n\n \n
1 Buyer
1.1 Buyer
Official name: Region Sjælland
\n
Legal type of the buyer: Regional authority
\n
Activity of the contracting authority: Health
\n
\n
\n
2 Procedure
2.1 Procedure
Title: Markedshøring Oncotype DX
\n
Description: Region Zealand is assisting the Danish Health Technology Council in conducting a market\n consultation about the existence of any CE marked non-invasive prognostic test to\n guide adjuvant chemotherapy treatment decisions for individuals with hormone receptor-positive\n (HR+), human epidermal growth factor receptor 2-negative (HER2-), early-stage (I-IIIa)\n invasive breast cancer. The test provides two pieces of information: 1. the recurrence\n risk and 2. the benefit of adding chemotherapy in order to reduce the risk. The test\n analyses the expression of 21 genes in breast tumour tissue based on RT-PCR. It does\n not require additional tumour material beyond the surgically excised tissue. This\n is the case because a company has requested the Danish Health Technology Council to\n assess their non-invasive prognostic test to guide adjuvant chemotherapy treatment\n decisions for individuals with HR+, HER2-, I-IIIa invasive breast cancer.
\n
Internal identifier: 2025-01-17
\n
2.1.1 Purpose
Main nature of the contract: Supplies
\n
Additional nature of the contract: Services
\n
Main classification (cpv): 38434520 Blood analysers
\n
Additional classification (cpv): 38432000 Analysis apparatus
\n
Additional classification (cpv): 85111810 Blood analysis services
\n
Additional classification (cpv): 85148000 Medical analysis services
\n
\n
2.1.2 Place of performance
Country: Denmark
\n
Anywhere in the given country
\n
\n
2.1.4 General information
Legal basis:
\n
Directive 2014/24/EU
\n
\n
\n
\n
3 Part
3.1 Part: PAR-0000
Title: Markedshøring Oncotype DX
\n
Description: Region Zealand is assisting the Danish Health Technology Council in conducting a market\n consultation about the existence of any CE marked non-invasive prognostic test to\n guide adjuvant chemotherapy treatment decisions for individuals with hormone receptor-positive\n (HR+), human epidermal growth factor receptor 2-negative (HER2-), early-stage (I-IIIa)\n invasive breast cancer. The test provides two pieces of information: 1. the recurrence\n risk and 2. the benefit of adding chemotherapy in order to reduce the risk. The test\n analyses the expression of 21 genes in breast tumour tissue based on RT-PCR. It does\n not require additional tumour material beyond the surgically excised tissue. This\n is the case because a company has requested the Danish Health Technology Council to\n assess their non-invasive prognostic test to guide adjuvant chemotherapy treatment\n decisions for individuals with HR+, HER2-, I-IIIa invasive breast cancer.
\n
Internal identifier: 2025-01-17
\n
3.1.1 Purpose
Main nature of the contract: Supplies
\n
Additional nature of the contract: Services
\n
Main classification (cpv): 38434520 Blood analysers
\n
Additional classification (cpv): 38432000 Analysis apparatus
\n
Additional classification (cpv): 85111810 Blood analysis services
\n
Additional classification (cpv): 85148000 Medical analysis services
\n
\n
3.1.2 Place of performance
Country: Denmark
\n
Anywhere in the given country
\n
\n
3.1.5 General information
Reserved participation: Participation is not reserved.
\n
The procurement is covered by the Government Procurement Agreement (GPA): yes
\n
This procurement is also suitable for small and medium-sized enterprises (SMEs)
\n
\n
3.1.6 Procurement documents
Address of the procurement documents: https://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=419895&B= ,
\n
Deadline for requesting additional information: 13-01-2025 11:00 +00:00
\n
\n
3.1.7 Terms of procurement
The execution of the contract must be performed within the framework of sheltered employment programmes: No
\n
\n
3.1.9 Further information, mediation and review
Review organisation: Klagenævnet for Udbud
\n
Organisation providing information concerning the general regulatory framework for taxes applicable in the place where the contract is to be performed: Konkurrence- og Forbrugerstyrelsen
\n
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
\n
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
\n
Organisation providing additional information about the procurement procedure: Region Sjælland
\n
Organisation providing offline access to the procurement documents: Region Sjælland
\n
Organisation providing more information on the review procedures: Klagenævnet for Udbud
\n
\n
\n
\n
8 Organisations
8.1 ORG-0001
Official name: Region Sjælland
\n
Registration number: 29190658
\n
Department: Koncern Indkøb
\n
Postal address: Alleen 15  
\n
Town: Sorø
\n
Postcode: 4180
\n
Country subdivision (NUTS): Vest- og Sydsjælland (DK022)
\n
Country: Denmark
\n
Contact point: Michael Lehmann Nielsen
\n
Email: michaeni@regionsjaelland.dk
\n
Telephone: +45 51647577
\n
Buyer profile: https://eu.eu-supply.com/ctm/company/companyinformation/index/137394
\n
Roles of this organisation:
Buyer
\n
Organisation providing additional information about the procurement procedure
\n
Organisation providing offline access to the procurement documents
\n
\n
\n
8.1 ORG-0002
Official name: Klagenævnet for Udbud
\n
Registration number: 37795526
\n
Postal address: Nævnerens Hus, Toldboden 2  
\n
Town: Viborg
\n
Postcode: 8800
\n
Country subdivision (NUTS): Vestjylland (DK041)
\n
Country: Denmark
\n
Email: klfu@naevneneshus.dk
\n
Telephone: +45 72405600
\n
Internet address: http://www.klfu.dk
\n
Roles of this organisation:
Review organisation
\n
Organisation providing more information on the review procedures
\n
\n
\n
8.1 ORG-0003
Official name: Konkurrence- og Forbrugerstyrelsen
\n
Registration number: 10294819
\n
Postal address: Carl Jacobsens Vej 35  
\n
Town: Valby
\n
Postcode: 2500
\n
Country subdivision (NUTS): Københavns omegn (DK012)
\n
Country: Denmark
\n
Email: kfst@kfst.dk
\n
Telephone: +45 41715000
\n
Internet address: http://www.kfst.dk
\n
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
\n
Organisation providing information concerning the general regulatory framework for environmental protection applicable in the place where the contract is to be performed
\n
Organisation providing information concerning the general regulatory framework for environmental protection applicable in the place where the contract is to be performed
\n
\n
\n
8.1 ORG-0004
Official name: Mercell Holding ASA
\n
Registration number: 980921565
\n
Postal address: Askekroken 11  
\n
Town: Oslo
\n
Postcode: 0277
\n
Country subdivision (NUTS): Oslo (NO081)
\n
Country: Norway
\n
Contact point: eSender
\n
Email: publication@mercell.com
\n
Telephone: +47 21018800
\n
Fax: +47 21018801
\n
Internet address: http://mercell.com/
\n
Roles of this organisation:
TED eSender
\n
\n
\n
\n
11 Notice information
11.1 Notice information
Notice identifier/version: 8bf13298-7d54-45d6-87b2-c2428e451e41 - 01
\n
Form type: Planning
\n
Notice type: Prior information notice or a periodic indicative notice used only for information
\n
Notice dispatch date: 19-12-2024 15:22 +00:00
\n
Notice dispatch date (eSender): 20-12-2024 11:00 +00:00
\n
Languages in which this notice is officially available: English 
\n
\n
11.2 Publication information
Notice publication number: 00790159-2024
\n
OJ S issue number: 249/2024
\n
Publication date: 23-12-2024
\n
Estimated date of publication of a contract notice within this procedure: 31-12-2025
\n
\n
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