DIAsource ImmunoAssays: An expert in clinical diagnostic products

With more than 30 years of experience in IVD (kits and instrumentation), DIAsource ImmunoAssays® S.A., a BioVendor Group company, is an international diagnostic company which has been based in Louvain-la-Neuve in a 7,500 m² facility for 10 years. It relies upon 80 employees, yields an annual turnover of €17 million and serves more than 80 countries.

Expertise and core activities

DIAsource ImmunoAssays® S.A. specializes in the development, manufacturing and marketing of clinical diagnostic products in the field of endocrinology, auto-immunity and infectious diseases. The company does everything from A to Z: order taking, development, production, quality control testing and delivery. Its success in business is based on 4 major principles: quality, service, affordability, and flexibility.

Currently DIAsource ImmunoAssays® S.A. produces around 70 diagnostic kits in-house and its catalogue contains over 350 different products. The company markets three technologies: radioactive RIA technology, ELISA technology based on colorimetry (detection by colour generation) and the brand new CLIA technology: based on chemiluminescence (production of light and heat as a result of a chemical reaction), this immunoassay successfully combines an antibody with a new diagnostic method.

In addition, the company supplies, installs and maintains PLCs for RIA and ELISA applications. It also produces antibodies used by competing companies to manufacture their own diagnostic kits — a win-win practice sanctioned by commercial agreements. And let’s not forget vitamin D assays for clinical and research purposes: the company was one of the first to develop and market a serum vitamin D kit.

Regulatory challenges and future outlook

This pioneering character will serve DIAsource ImmunoAssays® S.A. well as it prepares for a major change in European rules in 2022. At that time, the current In Vitro Diagnostics Directive will be replaced by a much more stringent regulation: the company’s entire range will be subject to approval by a Notified Body. DIAsource ImmunoAssays® S.A.’s priority is therefore clear: to obtain IVDR accreditation by 26 May 2022.

That said, the company is not forgetting its other objectives, starting with the further development of the CLIA technology in collaboration with a sister company of the BioVendor Group, based in the Czech Republic, of which it has been a member since 2017. Indeed, DIAsource ImmunoAssays® S.A. was built on the development of radioactive immunoassays. However, national legislation has become more and more restrictive over the years. Many companies have therefore decided to replace radioactive tests with non-radioactive tests. With DIAsource ImmunoAssays® S.A. they have the choice between the RIA and the ELISA tests. Alternatively, they can choose CLIA technology, most of which is fully automated, reducing human error and increasing performance compared to ELISA. DIAsource ImmunoAssays® S.A. is therefore well equipped to offer alternatives when regulatory constraints become too burdensome. Changing technology without changing supplier: a must!

Strategic growth through acquisitions

Another strategic focus for DIAsource ImmunoAssays® S.A. is the acquisition of 5 companies or parts of portfolios in 5 years. The latest of these is the French company CisBio, part of PerkinElmer, for which it has acquired the manufacturing and marketing rights. This acquisition will allow the company to market its entire radioactive portfolio as of 1 January 2022 and to exercise all manufacturing and marketing rights to the kits as of 26 May 2022. A promising expansionary policy for DIAsource ImmunoAssays® S.A..