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Diagnostics Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

The firm said that the test, a hematology-based cellular biomarker that identifies morphological changes within monocyte white blood cells, could speed diagnosis.

The test is based on RNA sequencing and is used to differentiate between idiopathic pulmonary fibrosis and other lung diseases in order to avoid surgery.

Industry executives said that clinical needs associated with antimicrobial resistance and sepsis are generating more interest in AST technologies.

The firm said that its new hematology-based cellular biomarker test has the potential to advance clinicians’ approach to sepsis triage and diagnosis.

The firm said that the new instrument, which prepares slides for cytology and aliquot samples for molecular testing, offers workflow benefits to clinical labs.