Submit offer Tailored biosafety lab training and UVI sensor PoC support for Kihleo

1. GENERAL INFORMATION: 

Titel of tender: Tailored biosafety lab training and UVI sensor PoC support for Kihleo

Your company’s name: Kihleo

Address: Strandgade 32a 1tv, 3000, Helsingør 

CVR nr.: 41105054

Date: 1/6/2026

Deadline for tender: 1/7/2026

For further questions, contact info: info@kihleo.dk

Phone and e-mail: +45 60186177  info@kihleo.dk

2. PRESENTATION OF COMPANY: 

Kihleo is a Danish health-tech startup developing a non-invasive sensor system for elderly care, focused on early indication of urinary tract infections (UTIs) in incontinent residents in nursing homes and home care. The solution combines a disposable insert containing a biochemical indicator with a sensor that reads color changes caused by bacteria-associated markers in urine and converts them into a clear signal for care staff, through a reuseable IoT device on the outside of the diaper. The purpose is to support earlier follow-up in daily care routines by providing an objective, data-driven indication before symptoms develops into more serious conditions. Kihleo is developing the solution as a workflow-integrated support tool for care staff, with emphasis on ease of use, passive monitoring and practical application in elderly care settings.

3. DESCRIPTION OF THE TASK UNDER MARKET EVALUATION: 

The task involves delivering a tailored competence development program consisting of specialized workshops for our internal team. The objective is to upskill our team in biosafety laboratory management (specifically GMO-1 environments), analytical bench testing of uropathogens to achieve proof-of-concept, and the strategic translation of laboratory findings into a compliant prototype for early-stage clinical investigation under MDR Article 82.

The training program must cover the following core areas:

●         Module 1: Laboratory Process Management & GMO-1 Infrastructure Planning

○         Competence development in structuring, managing, and maintaining standard operating procedures (SOPs) for a diagnostic wet lab.

○         Practical training on how to plan, license, and order equipment/materials for a GMO Class 1 (Genetically Modified Organism) laboratory environment in compliance with Danish regulations.

●         Module 2: Pathogen Bench Testing & Proof-of-Concept (PoC) Validation

○         Training in the safe planning, execution, and documentation of bench-top testing using common uropathogens (e.g., E. coli strains).

○         Methodologies for validating detection mechanisms, managing controls, and establishing data integrity to achieve a robust analytical Proof-of-Concept.

●         Module 3: Intro Workshop – Ethics Committee (Videnskabsetisk Komité) Application

○         An introductory workshop on navigating the application process for the Danish National Committee on Health Research Ethics (Videnskabsetisk Komité).

○         Guidance on preparing the foundational documentation (e.g., clinical protocol, patient information sheets) required to gain approval for testing on human biological samples.

●         Module 4: Translational Strategy – From Benchwork to MDR Article 82 Prototype

○         Strategic training on how to translate laboratory assay findings into a physical, testable prototype design.

○         Planning the transition from in-vitro lab validation to an early-stage clinical investigation prototype that complies with the safety and performance requirements of MDR Article 82.

4. TASK OBJECTIVES AND SUCCESS CRITERIA: 

The objective of this task is to upskill our team to independently run our biosafety laboratory operations, validate our diagnostic assay, and legally prepare for early-stage patient or sample testing, ensuring a clear roadmap from the lab bench to clinical validation.

Success criteria and measurable deliverables:

●         Workshop Material: Comprehensive training slides, GMO-1 compliance checklists, and laboratory validation guidelines tailored to diagnostic devices.

●         Regulatory & Lab Skabeloner: Operational templates in Google Docs format for a GMO-1 lab ordering log, an analytical bench test protocol, and an initial draft skeleton for a Videnskabsetisk Komité application.

●         Strategic Feedback Session: A dedicated review session where the bidder evaluates our team's preliminary laboratory testing plan and our translational strategy toward an Article 82 trial.

5. BUDGET OG SPECIFICATION OF AN OFFER: 

55.000 DKK excluding VAT 

6. BACKGROUND FOR THE TENDER: Beyond Beta is subject to a number of requirements for good, healthy financial management, including documentation that the agreed price for external purchases is an expression of the market price. This tender is part of these requirements. We emphasize that the bidder must only make an offer on the requested task. Services of executing or implementing nature cannot be approved. The winning bid is chosen based on an assessment of the best correlation between price and quality.