After buying Exosome Diagnostics for up to 575 million USD in 2018, bio-tech now closes site at IZB

Mikkel Noerholm, Ph.D., built the start-up, which develops diagnostic tests to detect tumor diseases using body fluids, since 2010

Ph.D. Mikkel Noerholm, Vice President Product Development, Exosome Diagnostics – a Bio-Techne brand

“Leading a biotech start-up from initial idea to development and launch of an in vitro diagnostic IVD product is a great achievement of our entire Exosome Diagnostics team.”

Ph.D. Mikkel Noerholm

Martinsried/ Munich, Nov. 24, 2021 – In 2010, the European subsidiary of the American company Exosome Diagnostics, headquartered in Waltham, Massachusetts, was founded as a research and development department at the Biotechnology Innovation and Start-up Center in Martinsried. The goal was to develop diagnostic tests that would spare cancer patients the stressful procedure of a biopsy. This project has been successfully implemented: Using body fluids, such as blood, urine, spinal or cerebrospinal fluid, it is now possible to detect tumor diseases with the test from Exosome Diagnostics. The ExoDx Prostate IntelliScore (EPI) is the world’s first diagnostic test in clinical practice to use biomarkers derived from exosomes and extracellular vesicles. This diagnostic test is intended for patients with suspected prostate cancer with a PSA in the gray zone (2-10 ng/ml) to aid in the decision to perform a biopsy. Mikkel Noerholm, Ph.D., built the start-up in Munich as Vice President Product Development.

This successful process also convinced U.S.-based Bio-Techne, headquartered in Minneapolis, Minnesota, USA, which employs 2,600 people and offers 500,000 life science and clinical diagnostic products. In June 2018, Bio-Techne acquired Exosome Diagnostics for USD 250 million. An additional USD 325 million was to be paid out if defined milestones were met. In total, the deal amounted to up to USD 575 million. Dr. Peter Hanns Zobel, managing director of IZB, said at the time, “We congratulate Exosome Diagnostics on this excellent deal, which is one of the largest company sales we have ever had at IZB.”

In recent years, Exosome Diagnostics’ European laboratory at IZB developed technologies and products for global use that are now licensed to and distributed by Qiagen (exoEasy). In addition, the company recently completed development of the company’s first in vitro diagnostic (IVD) product – EPI-CE. The facility also houses an ISO 15189-accredited clinical laboratory that performs patient testing and, for example, quickly developed a PCR test for SARS-CoV-2 during the first wave of the Covid 19 pandemic.

In October 2021, Bio-Techne decided to change the business model for exosome-based testing in Europe. As a result, the decision was made to close the Exosome Diagnostics laboratory at IZB in Munich at the end of October 2021. “We would like to thank the IZB for their support over the years and would just like to confirm what a fantastic home the IZB is for small and start-up companies in this field,” said Miles Ashton, Managing Director, Exosome Diagnostics EMEA, Bio-Techne.

As a result, Exosome Diagnostics is moving to a kit-only business model, where third-party laboratories will provide testing services for the ExoDx Prostate IntelliScore EPI-CE, rather than the Exosome Diagnostics lab in Martinsried, near Munich. The implementation of the EPI-CE test in well-known diagnostic laboratories in Germany and the UK is already well advanced. This model will then be extended to Spain, Italy and other European countries. Once the EPI-CE test is implemented in the new laboratories, the logistics of patient samples, testing and reporting of patient results will be handled by these laboratories.

“It’s sad, of course, that the site is closing and that the team, which has become like a family, has to part ways. But I am very proud of what we have achieved together over the last 10 years. Leading a biotech startup from the initial idea through development to launch of an in vitro diagnostic IVD product is a great achievement. Thus, Bio-Techne’s acquisition of the company for over $250 million is a tangible validation of the value the team has created. The decision to locate in Munich was a good one, and I am grateful for the warm welcome we have received, especially from the IZB and BioM, and for the great collaboration with scientists and clinicians in the area over the years. The location on the IZB campus is second to none and I hope to stay connected to the community in the future, whatever the next opportunity may bring,” says Mikkel Noerholm, Ph.D.

“IZB is proud to have supported Exosome Diagnostics on the successful path that ultimately led to the deal with Bio-Techne. We sincerely thank Mikkel Noerholm, Ph.D., who has been instrumental in shaping Exosome Diagnostics over the past years, and we are very reluctant to lose him. However, it has often been the case that our entrepreneurs return to the site with a new project,” said Dr. Peter Hanns Zobel, Managing Director IZB.