Devyser enters agreement with Thermo Fisher Scientific for commercialization of Devyser's post-transplant NGS products

• ­­Collaboration and distribution agreement with Thermo Fisher Scientific.
• Thermo Fisher Scientific obtains exclusive rights to commercialize Devyser's post-transplant monitoring portfolio in North America and Europe.

STOCKHOLM, April 24, 2023 /PRNewswire/ -- Devyser Diagnostics AB (publ) today announced that the company has signed an exclusive collaboration and distribution agreement with Thermo Fisher Scientific. The agreement gives Thermo Fisher exclusive rights to commercialize, under combined brands, Devyser's post-transplant portfolio of NGS products in North America and Europe.

"Partnering with Thermo Fisher, the leading innovator in the HLA industry, is a great opportunity for Devyser and a significant milestone for our company. Through this strategic partnership, clinical labs, clinicians and patients in the US, Canada and Europe will have broad and fast access to Devyser ́s innovative NGS based products for post-transplant monitoring. The agreement is also a quality stamp of our company and our products," says Fredrik Alpsten, CEO of Devyser.

The collaboration and distribution agreement signed today gives Thermo Fisher exclusive rights to market and sell, under combined brands, Devyser's post-transplant portfolio in North America and Europe. Devyser retains the rights to commercialize its post-transplant products in US via its own service laboratory, as a service to US laboratories. Devyser will continue to manufacture all products under the agreement.

"We are excited to partner with Devyser. Their post-transplant NGS offerings are unique and highly complementary to our existing, One Lambda-branded products. I'm confident our partnership will support better patient outcomes," says Nicole Brockway, President, Transplant Diagnostics, Thermo Fisher Scientific.

"Thermo Fisher is very well-established and positioned in both the US and European market, and with their commercial infrastructure and resources, they can cover both US and Europe efficiently. Our sensitive assays and streamlined work process give labs the ability to provide fast and trusted results. Further, the Devyser post-transplant products are pending IVDR certification for the European market. Together, our brands provide a strong proposition to customers and laboratories across the transplantation field. Devyser will continue to grow and focus on product development in the transplant field", says Theis Kipling, CCO of Devyser.

Devyser ́s post-transplant portfolio

Devyser ́s current transplant portfolio includes Devyser Chimerism for screening and follow-up of post stem cell transplantation and Devyser Accept cfDNA, a novel test for detection of donor derived cell free DNA in blood samples from kidney-transplant patients. Additional products for post-transplant monitoring are currently under development at Devyser ́s R&D unit in Stockholm.

Growing transplantation needs - kidney most common

The transplantation market is growing rapidly due to a growing older population and higher incidence of welfare diseases. There is a shortage of organs globally and many patients are currently on waiting lists for new organs.

Kidney transplantation is the most common organ transplantation. End-stage renal disease (ESRD) affects 2 million people globally. The most common causes for kidney disease are diabetes type 1, high blood pressure and inflammation of the kidney. In 2021 approximately 92,000 kidney transplantations were performed globally. Compared to dialysis, kidney transplantation provides higher patient survival and superior quality of life. From health economic perspective it is also more favorable.

For more information, please contact:

Fredrik Alpsten, CEO
Mail: fredrik.alpsten@devyser.com
Phone: + 46 70 667 31 06

Theis Kipling, CCO
Mail: theis.kipling@devyser.com
Phone: +46 73 598 07 76

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