Devyser has inaugurated its CLIA-certified laboratory and performed the first patient fetal RhD test
Devyser has inaugurated its CLIA-certified laboratory in Atlanta, Georgia. The laboratory will offer clinical test services for hereditary diseases, oncology, and post-transplant monitoring. The laboratory has already processed its first commercial test, examining a patient sample for fetal Rhesus D blood group status.
“The opening of our new CLIA-certified laboratory in Atlanta is a major milestone in increasing Devyser’s presence in the US, the biggest diagnostic market in the world. I am very proud of the Devyser team that has enabled us to have a fully operational and CLIA-certified laboratory within such a short time. We are excited to expand our clinical testing offering in the laboratory”, says Fredrik Alpsten, CEO at Devyser.
The laboratory will scale as demand grows and will initially focus on providing clinical testing services for healthcare providers and patients in the US. Devyser is currently working on reimbursement for each of the tests that will be part of the CLIA-certified laboratory test offering.
In May 2023, Devyser received CLIA certification from the Centers for Medicare and Medicaid Services (CMS), allowing the laboratory to run clinical laboratory tests on patient samples.
The information was submitted for publication, through the agency of the contact persons below, on June 30, 2023 at 08:00 CET.
For more information, please contact:
Fredrik Alpsten, CEO
Email: fredrik.alpsten@devyser.com
Telephone: +46 70 667 31 06
Sabina Berlin, CFO
Email: sabina.berlin@devyser.com
Telephone: +46 73 951 95 02
About Devyser
Devyser develops, manufactures and sells diagnostic solutions and analysis services to clinical laboratories in more than 50 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.
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 certified 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.
For more information, visit www.devyser.com
