Sweden-based diagnostic solutions provider Devyser has opened its new clinical laboratory improvement amendments (CLIA)-certified laboratory in Atlanta, Georgia, US.
The laboratory is intended to provide clinical test services for oncology, post-transplant monitoring, and hereditary diseases.
It has processed its first commercial test already, which involved examining a patient sample for the presence of the foetal Rhesus D blood group.
According to Devyser, the Atlanta lab will initially focus on offering clinical testing services to patients and healthcare professionals in the US. It will be expanded in future as the demand increases.
The diagnostic solutions provider is now working on reimbursement for each test included in the CLIA-certified laboratory test offering.
The Centres for Medicare and Medicaid Services (CMS) granted CLIA certification to Devyser in May 2023, enabling the facility to carry out clinical laboratory testing on patient samples.
Devyser CEO Fredrik Alpsten said: “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.”
Founded in 2004, Devyser offers products to enable targeted cancer treatment, the diagnosis of genetic diseases, and transplant patient follow-up.
The firm has eight in-house sales offices in Europe and the US.
Last month, the diagnostic solution provider introduced Devyser LynchFAP and Devyser BRCA PALB2 test kits to offer targeted and confident analysis of genes associated with elevated cancer risk.
