In September, the US Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion to a pathology laboratory concerning a proposed services ...
LDTs are diagnostic services developed, validated, and performed by professionals within a single clinical laboratory, often in response to individual physician orders. These services, which range ...
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...
ROCKVILLE, Md.--(BUSINESS WIRE)--LabGenomics USA, a subsidiary of LabGenomics Co., Ltd., announced its acquisition of QDx Pathology, a leader in molecular and diagnostic pathology. The acquisition is ...
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