The firm looks to position its Halo lung assay for detecting cancers not found by LDCT and in average-risk populations for which LDCT screening is not currently recommended.

The approval allows the company to offer its PD-L1 IHC 22C3 pharmDx Code SK006 CDx for ovarian and other cancers.

The lab firm said it now expects full-year net revenue in the range of $11.95 billion to $12.05 billion, up from its previous guidance of $11.78 billion to $11.90 billion.

The IVDR encompasses the firm's ER, PR, and Ki67 testing and completes certification of its overall digital pathology breast suite.

Precision Diabetes said on Thursday that it has acquired the exclusive US commercial rights to Nagase Diagnostics' Lucica Glycated Albumin-L assay for diabetes management. Financial and other terms of ...