Markedshøring om blodprøvediagnose af Alzheimers

Markedshøring om blodprøvediagnose af Alzheimers Markedshøring om blodprøvediagnose af Alzheimers

CPV: 71900000 Servicios de laboratorio, 85111810 Servicios de análisis de sangre, 85112000 Servicios de asistencia hospitalaria
Lugar de ejecución:
Markedshøring om blodprøvediagnose af Alzheimers
Organismo adjudicador:
Region Sjælland
Número de premio:
1

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 om blodprøvediagnose af Alzheimers
Description : Markedshøring om blodprøvediagnose af Alzheimers
Internal identifier : 1

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 85111810 Blood analysis services
Additional classification ( cpv ): 71900000 Laboratory services
Additional classification ( cpv ): 85112000 Hospital support services

2.1.2 Place of performance

Country : Denmark
Anywhere in the given country

2.1.4 General information

Additional information : Region Zealand is assisting the Danish Health Technology Council in conducting a market consultation about the existence of any CE marked technologies for early diagnosis of Alzheimer’s disease.This is the case because the Danish Health Technology Council has been requested by a company to assess their technology for early diagnosis of Alzheimer's disease.The overall purpose of the Danish Health Technology Council is to assess new or existing health technologies (cf. https://behandlingsraadet.dk/in-english). The technology submitted for the Danish Health Technology Council’s evaluation consists of a blood test that can both rule-out and rule-in amyloid pathology, and thus aid in the diagnosis of Alzheimer’s disease. The test is intended for individuals 55 and older undergoing evaluation for a cognitive complaint by a healthcare provider (HCP). The test is intended to be interpreted by an HCP in the context of additional clinical information, i.e. not for general population screening. The blood test identifies whether a patient has a low, moderate or high risk of suffering from Alzheimer's disease, which a clinician can utilize to establish a diagnosis.As part of the evaluation, the Danish Health Technology Council needs to know if other companies provide this or a similar CE marked technology. With a similar technology, we do not mean clinical examination such as Mini-Mental State Examination (MMSE) og Montreal Cognitive Assessment (MoCA), nor do we mean MRI, in-depth Neuro-Psychological evaluation, CSF biomarker analysis and/or amyloid PET.Please contact procurement officer Morten Thorsøe on mortt@regionsjaelland.dk and legal consultant Rachel Opuku Freeman on racf@regionsjaelland.dk in case your company provides the abovementioned CE marked technology. You will in turn be asked to provide documentation for your technology to be included in the council’s evaluation.
Legal basis :
Directive 2014/24/EU

3. Part

3.1 Part technical ID : PAR-0000

Title : Markedshøring om blodprøvediagnose af Alzheimers
Description : Markedshøring om blodprøvediagnose af Alzheimers
Internal identifier : 1

3.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 85111810 Blood analysis services
Additional classification ( cpv ): 71900000 Laboratory services
Additional classification ( cpv ): 85112000 Hospital support 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)
Additional information : Region Zealand is assisting the Danish Health Technology Council in conducting a market consultation about the existence of any CE marked technologies for early diagnosis of Alzheimer’s disease.This is the case because the Danish Health Technology Council has been requested by a company to assess their technology for early diagnosis of Alzheimer's disease.The overall purpose of the Danish Health Technology Council is to assess new or existing health technologies (cf. https://behandlingsraadet.dk/in-english). The technology submitted for the Danish Health Technology Council’s evaluation consists of a blood test that can both rule-out and rule-in amyloid pathology, and thus aid in the diagnosis of Alzheimer’s disease. The test is intended for individuals 55 and older undergoing evaluation for a cognitive complaint by a healthcare provider (HCP). The test is intended to be interpreted by an HCP in the context of additional clinical information, i.e. not for general population screening. The blood test identifies whether a patient has a low, moderate or high risk of suffering from Alzheimer's disease, which a clinician can utilize to establish a diagnosis.As part of the evaluation, the Danish Health Technology Council needs to know if other companies provide this or a similar CE marked technology. With a similar technology, we do not mean clinical examination such as Mini-Mental State Examination (MMSE) og Montreal Cognitive Assessment (MoCA), nor do we mean MRI, in-depth Neuro-Psychological evaluation, CSF biomarker analysis and/or amyloid PET.Please contact procurement officer Morten Thorsøe on mortt@regionsjaelland.dk and legal consultant Rachel Opuku Freeman on racf@regionsjaelland.dk in case your company provides the abovementioned CE marked technology. You will in turn be asked to provide documentation for your technology to be included in the council’s evaluation.

3.1.6 Procurement documents

3.1.7 Terms of procurement

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

3.1.8 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

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 : Morten Thorsøe
Telephone : +45 40493156
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) : Nordjylland ( DK050 )
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

10. Change

Version of the previous notice to be changed : 8b26277e-fd97-4524-892b-093d3bfb43fa-01
Main reason for change : Information updated
Description : The description field from the original tender form was not included in the announcement on TED, which is why we include it here again.

10.1 Change

Section identifier : PROCEDURE

11. Notice information

11.1 Notice information

Notice identifier/version : 5a744c7d-1759-411e-b574-5503aefbf732 - 01
Form type : Planning
Notice type : Prior information notice or a periodic indicative notice used only for information
Notice dispatch date : 13/12/2024 07:27 +00:00
Notice dispatch date (eSender) : 13/12/2024 07:30 +00:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00767265-2024
OJ S issue number : 244/2024
Publication date : 16/12/2024
Estimated date of publication of a contract notice within this procedure : 01/05/2025