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Devyser launches updated Y-Chromosomal microdeletion test


News | June 14, 2024

Devyser is proud to announce that its Y-chromosomal microdeletion test, Devyser AZF Extension, has been updated in accordance with the latest 2023 guidelines set by the European Molecular Genetics Quality Network (EMQN). This update makes Devyser AZF Extension the first test of its kind on the market to align with the newest EMQN standards, reinforcing our commitment to providing the most reliable and up-to-date genetic testing solutions.

“This update shows our ability to quickly update our products to meet the latest guidelines and requirements from the market. I am proud of the team that has made this update in a record pace”, says the Devyser CSO Michael Uhlin.  
“Since the EMQN update in 2023, we have extensively collaborated with our customers to develop the new version and we are grateful to all that took part in the evaluation.”   
The new version of the test, Devyser AZF Extension v2, will be available in mid-June as a Research Use Only (RUO) product. 
About male infertility 
Infertility affects 8–12% of couples worldwide and a male factor contributes to nearly 50% of couples infertility1. Azoospermia factor (AZF) deletions of the Y chromosome are the second most recurrent genetic cause of male infertility2. Studies indicate an increased prevalence of male infertility due to a combination of older parents and pollution, with an increase in prevalence of male infertility of 76.9% between 1990 and 20193.

  1. Male infertility. Vij al. Lancet, 2021
  1. EAA/EMQN best practice guidelines for molecular diagnosis of Y-chromosomalmicrodeletions: State of the art 2023, Krausz et al, Andrology, 2023 
  1. Global, regional and national burden of male infertility in 204 countries and territories between 1990 and 2019: an analysis of global burden of disease study, Huang B. et al, BMC Public Health, 2023 

For more information, please contact:
Fredrik Alpsten, CEO 
Telephone: +46 70 667 31 06
Theis Kipling, CCO
Telephone: +46 73 598 07 76

About Devyser
Devyser develops, manufactures and sells diagnostic solutions and analysis services to clinical laboratories in more than 65 countries. Our products are used for advanced genetic testing in the hereditary disease, oncology and transplant fields, to enable targeted cancer treatment, the diagnosis of a large number of genetic diseases, and transplant patient follow-up. Devyser's products, and unique, patented solution requiring only one test tube, simplify genetic testing processes, improve sample throughput, minimize hands-on time and deliver rapid results. Our goal is for every patient to receive a correct diagnosis in the shortest possible time. Sustainability is a central part of our business and an important prerequisite for long term value creation.

Devyser was founded in 2004 and is based in Stockholm, Sweden with eight in-house sales offices in Europe and the US. The company also runs Devyser Genomic Laboratories, a CLIA certified laboratory in Atlanta, US. In 2022, Devyser's quality management system was certified according to the IVDR and a number of the company's products have since been certified according to the IVDR.

Devyser's shares are listed on the Nasdaq First North Premier Growth Market Stockholm (ticker: DVYSR). The company's Certified Adviser is Redeye AB. 


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