Sweden-based Devyser has opened its new Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory in Atlanta, Georgia, US.
The new facility provides clinical test services for post-transplant monitoring, oncology and hereditary diseases.
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It has already performed the first commercial test by evaluating a patient sample for fetal Rhesus D blood group status.
Initially, the laboratory will offer clinical testing services for patients and healthcare providers in the US and scale up the services as demand increases.
The company is presently working on reimbursement for each of the tests, which will be part of the laboratory test offering.
In May this year, the company secured the Centers for Medicare and Medicaid Services (CMS) CLIA certification to perform clinical tests at the laboratory using patient samples.
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By GlobalDataDevyser 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.”
The company has also introduced two new genetic testing solutions, Devyser LynchFAP and Devyser BRCA PALB2, for hereditary cancer syndromes.
Devyser LynchFAP is intended for analysing PMS2 and nine other genes associated with hereditary colorectal cancer syndromes.
Devyser BRCA PALB2 has been developed to sequence genetic variants in BRCA1, BRCA2 and PALB2 genes, which increase breast cancer risk.
Alpsten said: “These genetic testing solutions represent a significant advancement in our hereditary cancer offering.
“By understanding mutations associated with increased cancer risks, our ambition is to enable more personalised care and preventive measures, ultimately saving lives.”
