Greiner Bio-One discontinues production of its diagnostics portfolio

Frickenhausen, August 2022 – Greiner Bio-One GmbH, a global player in the medical technology and life sciences industry, has decided to discontinue the product portfolio of its diagnostics division.

Key driver for the decision are regulatory requirements increasing with the new In Vitro Diagnostics Regulation (IVDR) which put the economic viability of the portfolio in question. For almost two decades, the company's diagnostics division has presented itself as a successful player in the dynamically growing molecular diagnostics market segment.

The products of the diagnostics division are all based on the DNA array as a key technology. The areas of application range from human diagnostics to applications in the pharmaceutical industry and quality control in food technology.

Almost 15 years ago, Greiner Bio-One made its debut in HPV diagnostics with the PapilloCheck^® genotyping assay. Today, the test is widely used in national screening programs for the prevention of cervical carcinoma. Great success has also been achieved with the CytoInspect mycoplasma test in quality control for vaccine and drug production.

Despite the successes achieved, Greiner Bio-One felt compelled to re-evaluate the medium- and long-term prospects for these products in light of the regulatory requirements associated with the IVDR.

After careful consideration and against the background of the stringent requirements to render the diagnostics products IVDR-compliant, Greiner Bio-One has decided to withdraw them from the market by the end of 2022. In addition, production of the entire diagnostics product portfolio, including non-IVD-regulated products, will be discontinued by mid-2023.

We’d like to thank all customers of the GBO diagnostic portfolio for their loyalty and for their understanding for this difficult decision.