Devyser announces its decision to establish a CLIA lab in Atlanta, Georgia, USA.

By operating a CLIA lab, Devyser obtains complete control of the selling process, including reimbursement management, ensuring value-based pricing and improved margins. It also allows for closer interaction with physicians and patients. The company aims to have the lab CLIA certified and fully operational in the second quarter 2023, it states in a press release.

“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.

Test services directly to its US customers

In parallel to its present business model, the inhouse lab enables Devyser to offer test services directly to its US customers, states the company. The customers will send test samples to the lab, that will run the tests and provide the customers with the final test results. 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.

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