NEW YORK – Devyser said Monday that it has received a CLIA license from the Centers for Medicare & Medicaid Services for its clinical laboratory in Atlanta.
The Stockholm-based molecular diagnostics firm said it will use the lab to perform testing for hereditary diseases, oncology, and post-transplant follow-up testing as well as direct-to-physician tests to manage patient care.
"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," Devyser CEO Fredrik Alpsten said in a statement.
Devyser also announced last month that it had signed an agreement giving Thermo Fisher Scientific exclusive rights to commercialize and distribute Devyser's post-transplant, next-generation sequencing tests in North America and Europe. In March, Devyser inked another agreement that lets the firm distribute Paragon Genomics' target enrichment technology and products in Italy.