For Diagnostic Laboratories

The WID®-easy test as IVDR Article 5 (5) test

The regulatory basis

Health institutions, such as diagnostic laboratories, have the possibility to manufacture and use the WID®-easy tests in accordance with Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) Article 5 (5) or corresponding national regulations.

The necessary scientific and technical information can be found in the published literature, in particular Evans et al, The Lancet Oncology, 2023.

Clarifications and comments

The WID®-easy PCR kit

Application

Diagnostic laboratories can obtain all necessary reagents for the production and use of the test from relevant suppliers.

To simplify logistics, healthcare facilities can obtain a set of reagents required to carry out the PCR reaction from Sola Diagnostics GmbH as an RUO PCR kit (“WID®-easy PCR Kit”).

The legal manufacturer of the RUO WID®-easy PCR Kit is Sola Diagnostics GmbH. The PCR kit was developed, verified and manufactured following ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, in collaboration with a renowned German contract manufacturer that has been active for over 20 years, .

Sola Diagnostics GmbH provides the WID®-easy PCR Kit to health institutions at a cost price with no profit margin.

Manual

The WID®-easy PCR Kit manual can be downloaded from the following link.

Safety data sheet

The WID®-easy PCR Kit safety data sheet can be downloaded from the following link.

Quality assurance

Certificates of analysis

Intellectual property rights

The performance and marketing of the WID®-easy test are subject to the intellectual property rights of University College London (“UCL”) and Sola Diagnostics GmbH.

“WID” is a registered trademark of Sola Diagnostics GmbH.

The rights to perform and market the WID®-easy test can be acquired from Sola Diagnostics GmbH as a license or sublicense (in the case of UCL rights). The licensing fee is calculated based on the number of reports billed by the health institution.