FDA Grants Humanitarian Use Device Designation To Circadian Technologies Ltd's VEGF-D Kit

Circadian Technologies Ltd announced that the US FDA has designated its VEGF-D assay kit as a humanitarian use device (HUD), for 'the detection of circulating VEGF-D intended to monitor patients who have been diagnosed with lymphangioleiomyomatosis (LAM) for disease progression and response to therapeutic intervention[. LAM is a debilitating lung disease which affects young women world-wide, with estimates at between 1,000-3,000 women in the United States and 100-300 in Australia. VEGF-D circulating in the blood has been shown to be a unique biomarker of this disease. Similar in concept to the FDA’s designation of orphan drug status to therapeutic drugs, an HUD is defined by the FDA as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. HUD designation enables formal approval of a HUD using a regulatory approval process known as a Humanitarian Device Exemption (HDE).