Request for Information: Methylation tests

This is not a call for tenders and does not obligate the Acquisition Unit of the Joint Authority of the Helsinki and Uusimaa Hospital District to any actions. The responses to this information request do not obligate the acquisition unit to any material or service acquisitions. HUS Laboratory of Genetics …

CPV: 33000000 Equipamiento y artículos médicos, farmacéuticos y de higiene personal, 33696000 Reactivos y medios de contraste, 33696500 Reactivos de laboratorio
Lugar de ejecución:
Request for Information: Methylation tests
Organismo adjudicador:
HUS-yhtymä
Número de premio:
HUS 327-2024

1. Buyer

1.1 Buyer

Official name : HUS-yhtymä
Legal type of the buyer : Regional authority
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : Request for Information: Methylation tests
Description : This is not a call for tenders and does not obligate the Acquisition Unit of the Joint Authority of the Helsinki and Uusimaa Hospital District to any actions. The responses to this information request do not obligate the acquisition unit to any material or service acquisitions. HUS Laboratory of Genetics at HUS (Helsinki University Hospital) Diagnostic Center is a SFS-EN ISO 15189:2022 accredited laboratory providing diagnostic and follow-up genetic testing services to all patients at Helsinki University Hospital area. MGMT methylation test in brain tumors has been used for years in our in-house laboratory processes. Due to the upcoming process change and the IVDR regulation, the laboratory is looking for a ready-to-use product based on DNA methylation markers suitable for determining the degree of methylation of the promoter region of the MGMT gene. The estimated number of studies per year is around 200. MLH1 promotor methylation test has been ordered from a foreign laboratory. Due to the length of the responses, we want to conduct the test in our own laboratory. For this test we are looking for a ready-to-use product based on DNA methylation markers suitable for determining the degree of methylation of the promoter region of the MLH1 gene. The estimated number of studies per year would be around 80. This Request for Information is released for preliminary evaluation and market research for potential replacement solutions for methylation of the promoter region of the MGMT and MLH1 genes. The product should be applicable to the equipment in the laboratory. The main objects of this information request are: - Which sample materials are suitable for research? Are the sample materials suitable for FFPE samples? - Is it possible to use an automated DNA isolation method (Maxwell/Qiasymphony) for the research? - Does the kit have a CE-IVD mark (IVDR regulation requirements)? - Does the kit have a plan to obtain the CE-IVD mark (IVDR regulation requirements)? - How many methylation markers are included in the kit? - Which equipment does the kit require? Please provide a list. - Which method is the research based on? Is it suitable for QuantStudio 5 or 6, Rotor-Gene? - Is the result quantitative? - Is there a threshold value set by the manufacturer for a positive result? - What is the sensitivity and accuracy of the method? - How many samples can be examined with one kit? - How many samples can be made in one run? - How long does the laboratory work + analysis of one sample take? - Does the kit include a positive and negative control? - Does the kit include reagents for the bisulfite conversion reaction? If not, does the manufacturer have a separate putty for this? - If the kit has a CE-IVD marking, is it specified in the kit which method should be used for bisulfite conversion? - Is there an analysis software available for the kit? - Is the analysis software free of charge or paid? - Does the analysis software subscription include software updates? - Is the software in a cloud service or can it be installed in the user's own closed operating environment? - Is the manual available electronically? - What is the price estimate for one sample? - Has the method been validated in prospective clinical drug trials? Please provide a list of any such trials. The response to this information request should include description of MGMT and MLH1 methylation test offered. An estimation of the turn-around-time and cost of service should also be included. All information obtained will be held confidential. INSTRUCTIONS ON RESPONDING TO REQUEST FOR INFORMATION: When registering, the contracting entity requests companies to provide also the following information: - product brochures, - any other relevant material; and - contact details of the company representative (name, telephone number, e-mail). If sensitive business-related information is provided in connection with the registration, please indicate this information as business secrets and to mark the files as ending with '_CLASSIFIED'. The contracting authority invites firms offering the above products to register and send replies and any other relevant material by 15.00 on 30 April 2025 at the latest to kilpailutus.tiimi@hus.fi . The subject should be marked "Response to request for information: HUS 327-2024 Methylation tests". FURTHER INFORMATION: The contracting authority may present further questions to the respondents to the request for information or, if necessary, arrange a remote meeting for a market dialogue. The purpose of this request for information is to obtain comprehensive information on the products in order to enable a possible call for tenders to be made. The contracting entity is not bound to carry out the procurement. Should the procurement be carried out, changes to the content of this notice are possible. The procuring entity reserves the right to split the procurement into lots. This request for information is not a procurement notice, prior information notice or invitation to tender, and the publication of this notice does not constitute an invitation to tender. Response to the information request is not a prerequisite for participation in any subsequent call for tenders, nor does responding to the information notice affect affect the tenderer's position in a possible tender procedure. Participants in a market dialogue are not entitled to compensation for their participation. Responses to the market dialogue do not bind the respondent in any subsequent tender procedure in any future procurement. The information collected during the market dialogue will remain confidential. Information obtained through a request for information may be used in procurement preparation.
Internal identifier : HUS 327-2024

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33000000 Medical equipments, pharmaceuticals and personal care products
Additional classification ( cpv ): 33696000 Reagents and contrast media
Additional classification ( cpv ): 33696500 Laboratory reagents

2.1.2 Place of performance

Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland

2.1.4 General information

Additional information : Technically, this notice has chosen not to divide the contract into lots. The procurement is expected to be split. The final parts to be procured will be determined from a possible call for tenders.
Legal basis :
Directive 2014/24/EU

3. Part

3.1 Part technical ID : PAR-0000

Title : Request for Information: Methylation tests
Description : This is not a call for tenders and does not obligate the Acquisition Unit of the Joint Authority of the Helsinki and Uusimaa Hospital District to any actions. The responses to this information request do not obligate the acquisition unit to any material or service acquisitions. HUS Laboratory of Genetics at HUS (Helsinki University Hospital) Diagnostic Center is a SFS-EN ISO 15189:2022 accredited laboratory providing diagnostic and follow-up genetic testing services to all patients at Helsinki University Hospital area. MGMT methylation test in brain tumors has been used for years in our in-house laboratory processes. Due to the upcoming process change and the IVDR regulation, the laboratory is looking for a ready-to-use product based on DNA methylation markers suitable for determining the degree of methylation of the promoter region of the MGMT gene. The estimated number of studies per year is around 200. MLH1 promotor methylation test has been ordered from a foreign laboratory. Due to the length of the responses, we want to conduct the test in our own laboratory. For this test we are looking for a ready-to-use product based on DNA methylation markers suitable for determining the degree of methylation of the promoter region of the MLH1 gene. The estimated number of studies per year would be around 80. This Request for Information is released for preliminary evaluation and market research for potential replacement solutions for methylation of the promoter region of the MGMT and MLH1 genes. The product should be applicable to the equipment in the laboratory. The main objects of this information request are: - Which sample materials are suitable for research? Are the sample materials suitable for FFPE samples? - Is it possible to use an automated DNA isolation method (Maxwell/Qiasymphony) for the research? - Does the kit have a CE-IVD mark (IVDR regulation requirements)? - Does the kit have a plan to obtain the CE-IVD mark (IVDR regulation requirements)? - How many methylation markers are included in the kit? - Which equipment does the kit require? Please provide a list. - Which method is the research based on? Is it suitable for QuantStudio 5 or 6, Rotor-Gene? - Is the result quantitative? - Is there a threshold value set by the manufacturer for a positive result? - What is the sensitivity and accuracy of the method? - How many samples can be examined with one kit? - How many samples can be made in one run? - How long does the laboratory work + analysis of one sample take? - Does the kit include a positive and negative control? - Does the kit include reagents for the bisulfite conversion reaction? If not, does the manufacturer have a separate putty for this? - If the kit has a CE-IVD marking, is it specified in the kit which method should be used for bisulfite conversion? - Is there an analysis software available for the kit? - Is the analysis software free of charge or paid? - Does the analysis software subscription include software updates? - Is the software in a cloud service or can it be installed in the user's own closed operating environment? - Is the manual available electronically? - What is the price estimate for one sample? - Has the method been validated in prospective clinical drug trials? Please provide a list of any such trials. The response to this information request should include description of MGMT and MLH1 methylation test offered. An estimation of the turn-around-time and cost of service should also be included. All information obtained will be held confidential. INSTRUCTIONS ON RESPONDING TO REQUEST FOR INFORMATION: When registering, the contracting entity requests companies to provide also the following information: - product brochures, - any other relevant material; and - contact details of the company representative (name, telephone number, e-mail). If sensitive business-related information is provided in connection with the registration, please indicate this information as business secrets and to mark the files as ending with '_CLASSIFIED'. The contracting authority invites firms offering the above products to register and send replies and any other relevant material by 15.00 on 30 April 2025 at the latest to kilpailutus.tiimi@hus.fi . The subject should be marked "Response to request for information: HUS 327-2024 Methylation tests". FURTHER INFORMATION: The contracting authority may present further questions to the respondents to the request for information or, if necessary, arrange a remote meeting for a market dialogue. The purpose of this request for information is to obtain comprehensive information on the products in order to enable a possible call for tenders to be made. The contracting entity is not bound to carry out the procurement. Should the procurement be carried out, changes to the content of this notice are possible. The procuring entity reserves the right to split the procurement into lots. This request for information is not a procurement notice, prior information notice or invitation to tender, and the publication of this notice does not constitute an invitation to tender. Response to the information request is not a prerequisite for participation in any subsequent call for tenders, nor does responding to the information notice affect affect the tenderer's position in a possible tender procedure. Participants in a market dialogue are not entitled to compensation for their participation. Responses to the market dialogue do not bind the respondent in any subsequent tender procedure in any future procurement. The information collected during the market dialogue will remain confidential. Information obtained through a request for information may be used in procurement preparation.
Internal identifier : HUS 327-2024

3.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33000000 Medical equipments, pharmaceuticals and personal care products
Additional classification ( cpv ): 33696000 Reagents and contrast media
Additional classification ( cpv ): 33696500 Laboratory reagents

3.1.2 Place of performance

Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland

3.1.5 General information

The procurement is covered by the Government Procurement Agreement (GPA) : yes
Additional information : Technically, this notice has chosen not to divide the contract into lots. The procurement is expected to be split. The final parts to be procured will be determined from a possible call for tenders.

3.1.6 Procurement documents

3.1.9 Further information, mediation and review

Review organisation : Markkinaoikeus -

8. Organisations

8.1 ORG-0001

Official name : HUS-yhtymä
Registration number : 1567535-0
Postal address : PL 441 (Uutistie 5, 01770 Vantaa)
Town : HUS
Postcode : 00029
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Contact point : HUS Procurement Services
Telephone : +358 94711
Internet address : http://www.hus.fi
Roles of this organisation :
Buyer

8.1 ORG-0002

Official name : Markkinaoikeus
Registration number : 3006157-6
Postal address : Radanrakentajantie 5
Town : Helsinki
Postcode : 00520
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Telephone : +358 295643300
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : Hansel Oy (Hilma)
Registration number : FI09880841
Postal address : Mannerheiminaukio 1a
Town : Helsinki
Postcode : 00100
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Contact point : eSender
Telephone : 029 55 636 30
Roles of this organisation :
TED eSender
Notice information
Notice identifier/version : 1359cf87-0f3b-480c-bb4e-8c0e5cb0816a - 01
Form type : Planning
Notice type : Prior information notice or a periodic indicative notice used only for information
Notice dispatch date : 17/04/2025 09:08 +00:00
Notice dispatch date (eSender) : 17/04/2025 09:09 +00:00
Languages in which this notice is officially available : English
Notice publication number : 00256373-2025
OJ S issue number : 77/2025
Publication date : 18/04/2025
Estimated date of publication of a contract notice within this procedure : 30/05/2025