Purpose of this request for information:

The purpose of this information request is:

1) To gather details and cost estimates related to B -P2Y12 assay, which measures platelet ADP receptor (P2Y12) inhibition in blood samples. The analysis is based on detecting of VASP (Vasodilator Stimulated Phosphoprotein) phosphorylation using an immunosorbent assay in microtiter plate format, with the read-out performed with a microplate photometer.

2) To gather details and cost estimates related to P -vWF-2N assay. The analysis differentiates von Willebrand disease (vWD) 2N from haemophilia A by measuring quantitative binding capacity of von Willebrand factor (VWF) to factor VIII (FVIII) in plasma samples, using an immunosorbent assay in microtiter plate format by performing the read-out with a microplate photometer.

The goal is to gather comprehensive information about available assay kits to facilitate a future call for tenders in the most appropriate manner. This request for information is not a call for tenders but aims to gather information and knowledge of the mentioned assays in the market. This prior information notice does not obligate HUS procurement unit for any actions. The suppliers are not paid for responding to this request for information or participating in a possible technical dialogue.

Background Information on the Procurement:

The Joint Authority of the Helsinki and Uusimaa Hospital District (HUS) is a joint authority consisting of 4 well-being counties. It is the largest healthcare operator in Finland. HUS is responsible for providing specialized care services for member municipalities and their residents. Nearly half a million patients are treated at HUS hospitals and clinics annually. The Helsinki University Hospital (HUH) is part of HUS. It is responsible for providing treatment for rare diseases or diseases that require demanding treatment for patients in the Helsinki University Hospital Specific Catchment Area, and in some cases, patients from all around the country. The members of HUS are the city of Helsinki and the four well-being services counties of Uusimaa: Western Uusimaa, Central Uusimaa, Eastern Uusimaa, and Vantaa-Kerava, and it employs approximately 27,000 professionals. The annual turnover of HUS is approximately three billion euros. HUS Logistics is part of the Joint Authority of the Helsinki and Uusimaa Hospital District organization. The Department acts as the joint procurement unit of the joint authority. It is responsible for the provision of procurement and logistics services and the availability of medical supplies, also during a crisis. More information about HUS and its operations can be found at www.hus.fi.

HUS Diagnostic Center’s Division of Clinical Chemistry is exploring options for performing (1) VASP / P2Y12 analysis and (2) von Willebrand factor 2N analysis by immune assays in patient samples for future procurement. VASP / P2Y12 analysis is performed as requested during the working week while the vWF binding ability to FVIII (for diagnosing vWF 2N) is performed as requested, a few times per year in batches. Both (1 and 2) analyses are performed at the HUS Diagnostic Center’s Automation Laboratory in the HUSLAB building in Helsinki. The procurement may include reagents and accessories needed to produce the above-mentioned analysis. The analyses (1 and 2) are intended to be performed manually.

The procurement may include, if possible:

- CE-marked reagent kit

The yearly number of B- P2Y12 samples has been about 300. However, the number of requested tests has been increasing and the assumption of the yearly amount of samples is about 500. The number of P -vWF2N tests has been about 5.

We inquire your views on the following matters (questions for companies):

- Would you be interested in giving an offer of the entity mentioned? We kindly ask for your opinion or view of the execution of the above-described entity.

- Are you willing to give a short Teams-presentation of your suggested solution? The presentation will be recorded for internal use of HUS Diagnostic Center.

- Please provide us with preliminary pricing information.

- Please describe earlier experiences of providing VASP/P2Y12 and vVWF 2N assays for laboratory diagnostics in a clinical laboratory. We ask you to state a reference from a clinical laboratory where the tests provided by your company are in use within the European Economic Area (EEA).

- How many references do you have for providing similar solutions into diagnostic clinical laboratories in the EEA?

- What kind of guarantee do you give to your products? What would be the delivery times for your products to Helsinki, Finland?

- Are your tests traceable to a standard? Which standard?

- Are the tests CE-IVDD or CE-IVDR compliant? If not, are they in a process to become CE-IVDR compliant?

- In which countries are your products manufactured?

- How is your product supply endured?

- What is the shelf-life of the test kit provided by your company?

Responses to this request for information should include replies to the above questions. Answers to this request for information are asked to be sent by e-mail to [email protected], at the latest on August 20th 2025.