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Regulatory press release

Diagonal Bio AB: Diagonal Bio announces successful external validation of LAMPlify® for respiratory viruses in horses

Diagonal Bio
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Diagonal Bio AB (publ) ("Diagonal Bio" and "the Company") announces that its diagnostic tool, LAMPlify® has undergone a successful external validation in accordance with ISO 17025 standards. It is confirming that LAMPlify® is as reliable as established real-time PCR (qPCR) methods for the detection of respiratory viruses in horses, including equine herpesvirus 1 (EHV-1) and equine herpesvirus 4 (EHV-4).

The recent validation study focused on evaluating the performance of LAMPlify® to detect EHV-1 and EHV-4 in horses. The study was conducted by the Department of Veterinary and Animal Sciences, at University of Copenhagen, and compared the performance of the LAMPlify® test with established real-time PCR (qPCR) assays, which serve as the gold standard in this field.

The samples used to assess the test's performance were carefully selected by the University of Copenhagen. The panel included virus isolates that had been cultured in cells, as well as nasal swab samples collected in Denmark during outbreaks of either EHV-1 or EHV-4. In total, seven verified positive samples for EHV-1 and eight verified positive samples for EHV-4 were included in the test panel.

The study's results demonstrated that all LAMPlify® tests, specific for either EHV-1 or EHV-4, showed 100% correlation with the respective qPCR tests. This indicates that LAMPlify® identified the same samples as positive or negative as the qPCR method. The study is confirming the reliability and accuracy of LAMPlify®.

The report from the University of Copenhagen also emphasised the user-friendliness and simplicity of the test procedure - "Our overall impression of the EHV-1 and EHV-4 LAMPlify®️ tests is that it is an easy test to perform, and the setup is easy to understand." This outcome underscores Diagonal Bio's commitment to offering innovative diagnostic solutions that combine high accuracy with ease-of-use.

"This external validation confirms the high quality and precision that LAMPlify® offers. These results are not surprising to us and are in line with our expectations and earlier external validations. We have always had full confidence in the performance of our LAMPlify® platform," - Karin Wehlin, CEO Diagonal Bio AB (publ)

This press release contains inside information that Diagonal Bio AB (publ) is required to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication on September 6, 2024, at 11:30 CET.

For additional information about Diagonal Bio AB

Please contact: Karin Wehlin, CEO

Phone: +46 703 052488

E-mail: kw@diagonalbio.com
Certified Adviser

Svensk Kapitalmarknadsgranskning AB

E-mail: ca@skmg.se
About Diagonal Bio

Diagonal Bio AB was founded in 2020 and is a Swedish biotechnology company with headquarters and offices in Lund. The Company develops the PANVIRAL® platform to detect and diagnose small sections of pathogen genomes, for example viruses, bacteria and fungi. The Company was founded with the goal of reducing human suffering by revolutionizing global diagnostics of pathogen-borne diseases with proprietary technology. Diagonal Bio's patented technology can also be used for the less regulated market segments via LAMPlify®.

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