00:49:06 Europe / Stockholm

Kurs & Likviditet

Kursutveckling och likviditet under dagen för detta pressmeddelande

Prenumeration

Kalender

2025-02-13 Bokslutskommuniké 2024
2024-10-30 Kvartalsrapport 2024-Q3
2024-07-23 Kvartalsrapport 2024-Q2
2024-05-15 X-dag ordinarie utdelning DVYSR 0.00 SEK
2024-05-14 Årsstämma 2024
2024-05-08 Kvartalsrapport 2024-Q1
2024-02-20 Bokslutskommuniké 2023
2023-11-09 Kvartalsrapport 2023-Q3
2023-08-23 Kvartalsrapport 2023-Q2
2023-05-11 X-dag ordinarie utdelning DVYSR 0.00 SEK
2023-05-10 Årsstämma 2023
2023-05-09 Kvartalsrapport 2023-Q1
2023-02-21 Bokslutskommuniké 2022
2022-11-10 Kvartalsrapport 2022-Q3
2022-08-24 Kvartalsrapport 2022-Q2
2022-05-12 X-dag ordinarie utdelning DVYSR 0.00 SEK
2022-05-11 Årsstämma 2022
2022-05-11 Kvartalsrapport 2022-Q1
2022-02-24 Bokslutskommuniké 2021

Beskrivning

LandSverige
ListaFirst North Stockholm
SektorHälsovård
IndustriMedicinteknik
Devyser Diagnostics utvecklar, tillverkar och säljer genetiska tester till laboratorier globalt. Produkterna används för DNA-tester inom onkologi, transplantation och ärftliga sjukdomar för att möjliggöra skräddarsydd cancerbehandling, diagnostik av ett stort antal genetiska sjukdomar och uppföljning av transplanterade patienter. Bolaget har sitt huvudkontor i Hägersten.
2024-04-25 11:30:00

Devyser has received IVDR approval for Advyser Solid organs, its software for the post-transplant product One Lambda Devyser Accept cfDNA. This is Devyser’s first European approval for post-transplant monitoring software under the new, more comprehensive IVD regulation that came into force in May 2022, and it confirms Devyser software meets the established safety, efficacy, and quality requirements.

"Achieving IVDR-certification for our software demonstrates Devyser’s commitment to pioneering genetic testing. This approval is another confirmation of our strong regulatory expertise and testament to the high quality, safety, and compliance of Devyser products," says CEO Fredrik Alpsten. "We are confident this approval will further enhance the growth potential of our transplantation products." 
 
Advyser Solid organs is an IVD software for monitoring donor-derived cell-free DNA (dd-cfDNA) in patients following kidney transplantation. The software is intended for use with One Lambda Devyser Accept cfDNA, a novel NGS test for detecting dd-cfDNA in blood samples from kidney transplant patients. The assay received IVDR approval in 2023. 

The product mentioned is CE-IVD marketed but not FDA-cleared. Availability in each country depends on local regulatory marketing authorization status. Please consult your local sales representative for details.