“The first quarter of the year saw continued strong growth, record gross margin and the launching of our first IVDR-approved product. After the end of the quarter, we were also able to announce an exclusive collaboration and distribution agreement with US-based Thermo Fisher Scientific. The agreement gives patients quick access to our transplant products and strengthens our global presence.”
Fredrik Alpsten, CEO, Devyser
The quarter from January to March 2023
Important events during the quarter
Devyser launches first IVDR-certified product
In March, Devyser launched Compact, the company’s first IVDR-certified product. This is a rapid genetic test for the diagnosis of fetal chromosomal abnormalities, and is the first in its field to be approved in accordance with the IVDR, the new, more comprehensive, European regulatory framework that came into force in May 2022. The product was launched back in 2006 and is now the leading standard for prenatal diagnosis in several European countries.
Important events after the end of the quarter
Devyser signs an agreement with Thermo Fisher Scientific
Devyser signed an exclusive collaboration and distribution agreement with Thermo Fisher Scientific in April. The agreement gives Thermo Fisher exclusive rights to market Devyser’s NGS products for post-transplant follow-up in North America and Europe.
Devyser wins the Swecare Export Award 2023
Devyser received the Swecare Export Award 2023 in April. This prize is awarded to companies that “with creativity, commitment and scope put Swedish innovation in health and healthcare on the world map”. The award was presented by Minister for Social Affairs Jacob Forssmed.
Devyser's clinical laboratory CLIA certified
Devyser's clinical laboratory in Atlanta received in May CLIA certification. The certification allows Devyser to begin testing on patient samples.
Presentation
This report and previous financial reports are available on the company’s webpage https://investors.devyser.com/en/reports-presentations.
This information is information that Devyser Diagnostics AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation 596/2014. The information was submitted for publication, through the agency of the contact persons below, on May 9, 2023, at 07:30 CET.
For more information, please contact:
Fredrik Alpsten, CEO
E-mail: fredrik.alpsten@devyser.com
Tel: +46 706 673 106
Sabina Berlin, CFO
E-mail: sabina.berlin@devyser.com
Tel: +46 739 519 502
About Devyser Diagnostics AB (publ)
Devyser develops, manufactures and sells diagnostic solutions and analysis services to clinical laboratories in more than 50 countries. Our products are used for complex 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.
Devyser was founded in 2004 and is based in Stockholm, Sweden. The company has eight in-house sales offices in Europe and the US, and a CLIA laboratory in Atlanta, Georgia. In August 2022, Devyser's quality management system and Devyser Compact were 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.