By now we’ve all probably heard of LDTs (laboratory developed tests) and the FDA’s decision to begin exercising regulatory authority over them in the near future.  Unless you work in a large reference lab, a molecular lab, or in an esoteric subsection of the lab you probably thought this had nothin...(Read More)

Perhaps it has come to this. On June 1, 2011 a new guidance document draft was released for comment by the US Department of Health and Human Services, the FDA, the Center for Devices and Radiological Health, the Office of In Vitro Diagnostic Device Evaluation and Safety and the Center for Biologica...(Read More)

Type 1 diabetes mellitus (T1DM) is an autoimmune disease that results from the cell-mediated destruction of islet beta cells. Approximately 12,000 to 15,000 children and adults annually develop T1DM. Over a period of 50 years, this amounts to 600,000 to 750,000 affected individuals. As well, these ...(Read More)

A 58-year-old man underwent MRI total body imaging. Later that day, a chemistry profile was ordered. The total calcium was measured at 4 mg/dL (reference interval: 8.5-10.5 mg/dL) and the albumin was 4 g/dL (reference interval: 3.5-5.0 g/dL). The patient was examined and lacked any clinical evidenc...(Read More)