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Datum Källa Rubrik Typ Alternativ
2023-01-27 Devyser Diagnostics Devyser Diagnostics AB: Devyser makes provisions due to retroactive "payback" levy Pressreleaser Visa Stäng
2023-01-27 Devyser Diagnostics Devyser Diagnostics AB: Devyser gör reservering på grund av retroaktiv "payback"-avgift Pressreleaser Visa Stäng
2022-12-02 Penser Access Penser Access: Lockande läge inför 2023 - Devyser Analyser Visa Stäng
2022-11-15 Analysguiden Analysguiden: ANALYS Devyser: Stabilt kvartal och många pusselbitar faller på plats Analyser Ladda ner | Visa Stäng
2022-11-15 Penser Access Penser Access: Intervju med Devyser - Erik Penser Bank - 15 nov 2022 Analyser Visa Stäng
2022-11-11 Redeye Redeye: Devyser Q3 - Solid performance and strong gross margin Analyser Ladda ner | Visa Stäng
2022-11-10 Pinpoint Estimates Pinpoint Estimates: Devyser Diagnostics rapport i linje med Pinpointkonsensus Analyser Ladda ner | Visa Stäng
2022-11-10 Devyser Diagnostics Devyser Diagnostics AB publishes Interim Report for the period, January to September 2022 Rapporter Ladda ner | Visa Stäng
2022-11-10 Devyser Diagnostics Devyser Diagnostics AB publicerar delårsrapport för januari till september 2022 Rapporter Ladda ner | Visa Stäng
2022-11-09 Devyser Diagnostics Devyser Diagnostics AB: Devyser strengthens its presence on the US market - establishes proprietary CLIA lab Pressreleaser Visa Stäng
Pressreleaser | 9 Nov 2022 | Devyser

Devyser Diagnostics AB: Devyser strengthens its presence on the US market – establishes proprietary CLIA lab

”The establishment of an in-house CLIA lab is an important milestone in our ambition to strengthen Devyser’s presence in USA, the biggest IVD market in the world. Although USA accounts for a minor share of our total sales to date we are convinced that North America and the US will ultimately become our most important and profitable market,” says Fredrik Alpsten, CEO of Devyser.

In parallel to its present business model, the inhouse lab enables Devyser to offer test services directly to its US customers. The customers will send test samples to the lab, that will run the tests and provide the customers with the final test results. The lab will initially offer test services for Devyser’s top selling products. Devyser has signed a lease for the premises and started recruiting lab personnel. The initial workforce is expected to consist of five employees. The lab will also be used for training and education of customers.

”We see many advantages in operating a CLIA lab in the US. Direct contact with physicians and patients will be a critical success factor for our commercialization on the US market. Furthermore, it enables us to be in the driver’s seat of securing the quality and compliance that is necessary for reimbursement. We have seen several strong reference cases of successful launches of high-value diagnostics tests using this model,” says Theis Kipling, CCO of Devyser.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all US facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat diseases. Devyser has chosen Atlanta as the preferred location based on its standing as a center within the pharmaceutical and diagnostic industry, which will facilitate the recruitment of qualified lab personnel. The new premises are close to Atlanta airport, the biggest in the US, enabling fast shipments of blood samples. The location on the east side of the US will facilitate the collaboration with Devyser in Europe.

The information was submitted for publication by the contact persons below on November 9, 2022 at 11:00 CET.

For more information, please contact:

Fredrik Alpsten, CEO
Email: fredrik.alpsten@devyser.com

Telephone: +46706 673106

Sabina Berlin, CFO
Email: sabina.berlin@devyser.com
Telephone: +46 739 519502

About Devyser Diagnostics AB (publ)

Devyser develops, produces, and sells genetic testing kits to laboratories in more than 45 countries. The products are used for advanced DNA 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 monitoring. Devyser’s products simplify complex genetic testing processes, improve sample throughput, minimize hands-on time and deliver rapid results. The company was founded in 2004 and is based in Stockholm, Sweden.

Devyser’s shares are listed on the Nasdaq First North Growth Market Stockholm (ticker: DVYSR). The company’s Certified Adviser is Redeye AB. For more information, visit www.devyser.com.

2022-11-09 Devyser Diagnostics Devyser Diagnostics AB: Devyser stärker sin närvaro i USA - öppnar eget CLIA-laboratorium Pressreleaser Visa Stäng
2022-11-08 Penser Access Penser Access: Tillväxt i sitt DNA - Devyser Analyser Visa Stäng
2022-11-02 Devyser Diagnostics Devyser Diagnostics AB: Inbjudan till audiocast för Devysers Q3-rapport 2022 Pressreleaser Visa Stäng
2022-11-02 Devyser Diagnostics Devyser Diagnostics AB: Invitation to audiocast for Devyser's Q3 Report 2022 Pressreleaser Visa Stäng
2022-11-01 Devyser Diagnostics Devyser Diagnostics AB: Devyser appoints John Murad as General Manager in the US Pressreleaser Visa Stäng
2022-11-01 Devyser Diagnostics Devyser Diagnostics AB: Devyser utser John Murad till General Manager i USA Pressreleaser Visa Stäng
2022-10-31 Devyser Diagnostics Devyser Diagnostics AB: Devyser appoints Carnegie Investment Bank AB as liquidity provider Pressreleaser Visa Stäng
2022-10-31 Devyser Diagnostics Devyser Diagnostics AB: Devyser utser Carnegie Investment Bank till likviditetsgarant Pressreleaser Visa Stäng
2022-08-29 Devyser Diagnostics Devyser Diagnostics AB: Devysers kvalitetsledningssystem och produkt för fosterdiagnostik godkända enligt nya europeiska IVDR-regelverket Pressreleaser Ladda ner | Visa Stäng
2022-08-29 Devyser Diagnostics Devyser Diagnostics AB: Devyser's quality management system and fetal diagnostics product approved under the new European IVD Regulation Pressreleaser Ladda ner | Visa Stäng
2022-08-29 Redeye Redeye: Devyser Q2 - Delivering well on its financial targets Analyser Ladda ner | Visa Stäng
2022-08-26 Analysguiden Analysguiden: ANALYS Devyser Diagnostics: Stark tillväxt och vinner viktig mark i Kanada Analyser Ladda ner | Visa Stäng
2022-08-24 Pinpoint Estimates Pinpoint Estimates: Devyser Diagnostics nettoomsättning strax under Pinpointkonsensus Analyser Ladda ner | Visa Stäng
2022-08-24 Devyser Diagnostics Devyser Diagnostics AB publicerar delårsrapport för januari till juni 2022 Rapporter Ladda ner | Visa Stäng
2022-08-24 Devyser Diagnostics Devyser Diagnostics AB publishes Interim Report for the period, January to June 2022 Rapporter Ladda ner | Visa Stäng
2022-08-18 Devyser Diagnostics Devyser Diagnostics AB: Devyser appoints Camilla Wiberg as Chief HR Officer Pressreleaser Visa Stäng
2022-08-18 Devyser Diagnostics Devyser Diagnostics AB: Devyser utser Camilla Wiberg till Chief HR Officer Pressreleaser Visa Stäng
2022-08-17 Pinpoint Estimates Pinpoint Estimates: Devyser Diagnostics inleder samarbete med estimattjänsten Pinpoint Estimates Analyser Ladda ner | Visa Stäng
2022-08-17 Devyser Diagnostics Devyser Diagnostics AB: Inbjudan till audiocast för Devysers Q2-rapport 2022 Pressreleaser Visa Stäng
2022-08-17 Devyser Diagnostics Devyser Diagnostics AB: Invitation to audiocast for Devyser's Q2 Report 2022 Pressreleaser Visa Stäng
2022-06-22 Devyser Diagnostics Devyser Diagnostics AB: Devyser wins breakthrough contract in Canada for non-invasive fetal RHD testing Pressreleaser Ladda ner | Visa Stäng
2022-06-22 Devyser Diagnostics Devyser Diagnostics AB: Devyser vinner genombrottskontrakt i Kanada för icke-invasiv RHD-testning av foster Pressreleaser Ladda ner | Visa Stäng
2022-06-07 Analysguiden Analysguiden: INITIERINGSANALYS DEVYSER DIAGNOSTICS: Snabbväxare inom gentest med skyhöga marginaler Analyser Ladda ner | Visa Stäng
2022-05-12 Redeye Redeye: Devyser - A Strong Start to 2022 Analyser Ladda ner | Visa Stäng
2022-05-11 Devyser Diagnostics Kommuniké från årsstämma i Devyser Diagnostics AB (publ) den 11 maj 2022 Pressreleaser Ladda ner | Visa Stäng
2022-05-11 Devyser Diagnostics Bulletin from the Annual General Meeting of Devyser Diagnostics AB (publ) held on 11 May 2022 Pressreleaser Ladda ner | Visa Stäng
2022-05-11 Devyser Diagnostics Devyser Diagnostics AB: Record sales and increased gross margin for Devyser Rapporter Ladda ner | Visa Stäng
2022-05-11 Devyser Diagnostics Devyser Diagnostics AB: Rekordförsäljning och ökad bruttomarginal för Devyser Rapporter Ladda ner | Visa Stäng
2022-05-10 Devyser Diagnostics Devyser Diagnostics AB: Devyser presenterar på Aktiedagen Göteborg den 16 maj Pressreleaser Visa Stäng
2022-05-02 Devyser Diagnostics Devyser Diagnostics AB: Inbjudan till audiocast för Devysers Q1-rapport 2022 Pressreleaser Visa Stäng
2022-05-02 Devyser Diagnostics Devyser Diagnostics AB: Invitation to audiocast for Devyser's Q1 Report 2022 Pressreleaser Visa Stäng
2022-04-13 Devyser Diagnostics Kallelse till årsstämma 2022 i Devyser Diagnostics AB Pressreleaser Ladda ner | Visa Stäng
2022-04-12 Devyser Diagnostics Devyser Diagnostics AB: Devyser ökar kommersiellt fokus genom nyrekrytering till ledningsgruppen Pressreleaser Ladda ner | Visa Stäng
2022-04-12 Devyser Diagnostics Devyser Diagnostics AB: New appointment to Devyser's management team enhances commercial focus Pressreleaser Ladda ner | Visa Stäng
2022-04-06 Devyser Diagnostics Devyser Diagnostics AB: Devyser publishes annual report for 2021 Rapporter Ladda ner | Visa Stäng
2022-04-06 Devyser Diagnostics Devyser Diagnostics AB: Devyser publicerar årsredovisning för 2021 Rapporter Ladda ner | Visa Stäng
2022-04-06 Redeye Redeye: Redeye Initiates Coverage of Devyser Analyser Ladda ner | Visa Stäng

Kommande händelser

21 Feb 2023 | Bokslutskommuniké 2022
9 May 2023 | Kvartalsrapport 2023-Q1
10 May 2023 | Årsstämma 2022
23 Aug 2023 | Kvartalsrapport 2023-Q2
9 Nov 2023 | Kvartalsrapport 2023-Q3