Market Consultation for Bladder Cancer Methylation Test Solutions

REQUEST FOR INFORMATION: Bladder Methylation Test With this request for information, HUS launches a market consultation to prepare a procurement. The aim of this prior information notice is to find suppliers operating in this field of business, get information of the solutions available in the market, and inform our plans and requirements for the forthcoming procurement.

DESCRIPTION OF THE SUBJECT OF THE REQUEST FOR INFORMATION 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. Diagnosis and monitoring of bladder cancer still require cystoscopy and urine cytology.

Commercial non-invasive, urine-based methylation tests are available, but are not publicly available in Finland. Guidelines of European Association of Urology (EAU) recommend urinary biomarkers can be used to prolong endoscopy intervals and in equivocal cases.

Our laboratory is looking for all-in-one product based on methylation markers suitable for determining the degree of methylation of the promoter regions of the several cancer genes. It is difficult to estimate number of studies per year, but should be thousands of samples.

This Request for Information is released for preliminary evaluation and market research for potential solutions for methylation of the promoter region of the cancer genes and it includes a request for information regarding two different test formats: a standard test (A) and a rapid test (B).

INSTRUCTIONS FOR ANSWERING Responses to this request for information must be submitted by email to kilpailutus.diagnostiikka@hus.fi no later than 17 March 2026. The subject line of the email must include: HUS 440-2025 Bladder Methylation Test. A response may be submitted for either one or both test formats.

The response must include all the information requested below for the test format to which the respondent chooses to respond. The respondent is also requested to provide a contact person and an email address for any potential subsequent one-to-one market dialogue and/or additional information requests from the contracting authority.

Respondents may also attach any available brochures related to the proposed products or services. A) Bladder Methylation Test - the product should be applicable to the equipment in the laboratory: - How much urine the test needs ? - Is the use of automated DNA isolation methods (for example: Maxwell/QIA Symphony) acceptable if DNA isolation is needed? - 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? - What kind of equipments does the kit require? List what. - What method is the research based on? Is it suitable for QuantStudio 5 or 6 ? - 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? - Is bisulfite conversion necessary? 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? - 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? List where. - Description of the methylation test offered - Estimation of the turn-around-time - Estimation of the cost of the service (e.g., product support and training) A) Rapid Bladder Methylation Test: - What kind of equipments and kits does the test require?

List what. - 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? - Is the result quantitative? - 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?

- Does the kit include a positive and negative control? - How long does the laboratory work + analysis of one sample take? - Is the analysis software free of charge? - 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? List where. - Description of the methylation test offered - Estimation of the turn-around-time - Estimation of the cost of the service (e.g., product support and training),