Fetal RHD screening NIPT | May 8, 2023
Devyser is today announcing that the company’s clinical testing laboratory in Roswell in Atlanta, Georgia, has received CLIA certification. This certification allows the Devyser US lab to begin testing on patient samples.
The Certificate of Registration has been issued to the Devyser laboratory by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA).
“The CLIA certification is very important for us, and we are proud that our new CLIA lab will give access to patients and their physicians to novel laboratory developed tests”, says Fredrik Alpsten, CEO at Devyser.
Certification of the Devyser lab under CLIA enables highly useful testing for hereditary diseases, oncology, and post-transplant follow-up. The Devyser lab will offer test services directly to US physicians. The physicians will send test samples to the lab that will run the tests and provide the physicians with test results that can be used to manage patients.
The information was submitted for publication, through the agency of the contact persons below, on May 8, 2023, at 07:00 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 73 598 07 76
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 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.
