- - Market dialogue LIMS molecular pathology
Invitation to Participate in the Market Dialogue
In the spring of 2025, the Capital Region of Denmark and Region Zealand conducted a preliminary market assessment regarding LIMS for pathology with selected LIMS vendors, as preparation for a more targeted market dialogue. The initial market assessment revealed that some aspects remain unclear for the regions regarding what the market is able to offer. This is especially the case for molecular pathology, where further insight is needed into which standard systems, currently available on the market, can meet the identified needs and how they do so—particularly how they support seamless digital integration with the pathology unit’s “classical pathology” workflow.
The regions thus wish to gain greater insight into what the market can deliver and are therefore initiating the present market dialogue, consisting of two separate sessions: one targeting the pathology unit’s “classical pathology” and one targeting the pathology unit’s “molecular pathology”. There will be overlapping requirements between the two.
It is important to note that the regions have not yet decided whether the future procurement will involve one or two integrated LIMS solutions. The market dialogue is intended to help clarify this.
About the way of working in the pathology units in Denmark
There is a close collaboration between classical pathology and molecular pathology in Denmark. The molecular pathology domain is an integrated part of pathology unit and embedded within the specialty. Diagnostic reports may include results from both classical pathology and molecular pathology, but may also be exclusively associated with a workflow either in classical pathology or molecular pathology.
Classical pathology refers to:
The workflows within pathology departments for histology, cytology, and associated subspecialties tied to these laboratory areas and their diagnostic reporting processes. This consists of Anatomical Pathology and surgical pathology and also includes screening programs for cervical cancer, colorectal cancer, and breast cancer.
Molecular pathology refers to:
The laboratory workflows and analyses associated with variant interpretation and molecular diagnostic reporting, e.i “NGS (Next-Generation Sequencing)”, “Prosigna–Gene Expression Profile”,”ddPCR(digital dropletPCR)”, “ctDNA(circulatingtumourDNA)”, “HPV-screening –prevention of cervixcancer”, “VisionArray–vira and bacteria”, “Agena–Mass Array”, “Epigenetics, fx methylering” etc. Molecular analyses are used not only for diagnostic purposes, but also to support treatment decision-making and monitoring, both in evidence-based and experimental treatment pathways. This means that molecular pathology requires the ability to report in multiple formats and must be able to trace the full sample pathway.
The above workflow diagrams outline, at a high level, the sample journey from requisition to result reporting for patient specimens handled by the pathology department, including the molecular pathology domain. Each main subprocess—e.g., grossing, embedding, microtomy, etc.—can be further divided into subprocesses. For example, grossing involves different subprocedures depending on whether the sample is categorized as simple histology, complex histology, or cytology. These can be further broken down depending on topography, clinical history, priority, etc.
Pathology is a complex specialty with numerous workflows and subspecialties depending on sample and material types, such as differentiation of grossing into simple/complex histology and cytology, cervical cancer screening, immunohistochemistry (IHC), frozen section, autopsy, hematopathology, dermatopathology, gastrointestinal pathology, and others.
Additionally, the specialty in Denmark is highly digitized, with a very low reliance on paper requisitions, rule-based sample reception, and integration with external systems and instruments.
Therefore, the high-level workflow diagram does not fully represent the comprehensive processes, tasks, or digital support requirements of the pathology specialty, nor the futureproofing needs. Instead, it presents an aggregate of the main processes that a future LIMS solution must be able to support. It should also be noted that the sample’s journey is rarely linear through the illustrated process.
Molecular pathology operates in a separate laboratory from clinical genetics. Requisition to molecular pathology may occur internally from a pathologist or externally.
External requisition happens, for example, directly from the oncology unit to the molecular pathology part of the pathology unit and does not involve classical pathology of the pathology unit. Internal requisition may occur at multiple stages in the general pathology sample flow within the pathology unit. Moreover, molecular pathology also receives samples from international hospitals/ordering units.
In molecular pathology, different departments have distinct sample portfolios and therefore distinct analysis types. It will be necessary to integrate LIMS for Molecular Pathology with instruments and devices involved in conducting molecular analyses. A unique requirement for molecular pathology is also the need to perform structured searches in a variant database, which is expected to be embedded within the future LIMS system.
Participation in the targeted market dialogues
Through EU Supply, the regions are inviting companies that have delivered relevant standard solutions to clients comparable to the Danish regions. The market dialogue will consist of both virtual meetings and written material, with requests for written responses from participating companies.
Objectives of the Market Dialogue
- To provide the regions with insight into what solutions the market can offer in relation to the regions’ specific business needs and the market’s expectations for future development.
- To obtain feedback from the market on initially identified requirements in order to:
- Ensure that the regions set realistic requirements in relation to what suppliers can deliver.
- Identify inappropriate or overly restrictive requirements that could, for example, deter relevant suppliers from bidding or unnecessarily increase solution costs.
Other Danish Regions
The other 3 Danish regions are also involved in this dialogue, though it has not yet been decided whether they will participate in a future joint procurement with the Capital Region and Region Zealand.
Application for participation
The application to participate in the market dialogue must be no more than 3 pages and should include the following information:
- A brief description of the standard LIMS solution for molecular pathology offered by the company, indicating which functional areas are supported for both laboratory and diagnostic work. If the standard LIMS is adapted from, for instance, a genetics LIMS, please explain why and how this was done, the rationale behind the adaptation, and whether there is an integration with a LIMS for classical pathology. Please also indicate the annual number of requisitions processed in the LIMS.
- A brief description of your company’s latest up to 5 customer references (who and when) in relation to delivering a standard LIMS for molecular pathology, covering both laboratory and molecular biologist/pathologist workflows.
- Your company name and CVR number (or equivalent company registration number from the country of establishment) for all participating companies. If multiple companies are participating together in the market dialogue, this must be clearly indicated in the application.
Due to limited resources, the regions may need to limit the number of participants in the market dialogues. It is up to each applicant to decide in which consortium or configuration they wish to participate.
Companies interested in participating must submit a request via EU Supply using the messaging module. Submissions will not be accepted through any other channel, and the specified deadline must be respected.
If your company does not already have an EU Supply account, you are encouraged to create one.
All inquiries related to this market dialogue must be submitted via the EU Supply messaging module. Technical issues with the electronic procurement system should be directed to technical support:
(https://support.mercell.com/space/EUSD)
Deadline for Application: August 15 2025
Region Zealand reserves the right to request additional information from vendors regarding their products or company.
Selected companies can expect to receive a response to their application for participation in the market dialogue by August 22-29 2025, with a list of questions to be answered and with a response deadline to follow approximately 1–2 weeks later.
Additional Information
Please note that any costs incurred by companies in relation to this market dialogue are the sole responsibility of the companies.
Participation in the market dialogue does not grant any direct influence on the future tender materials.
Failure to participate in the market dialogue (or not being selected) will not affect a company’s opportunity to be prequalified to participate in the upcoming tender.
While prequalification is about assessing supplier suitability, the purpose of this market dialogue is to gain a better understanding of the market’s capabilities.
Upon request, we can provide you with the link to the market dialogue for LIMS for classical pathology.
It is possible to submit applications for both dialogues if the company offers standard products that meet the respective needs.
We look forward to continuing the dialogue with your company via EU Supply.
Best regards,
Lasse Højer-Pedersen, responsible project manager for the tender process