Designated ‘Breakthrough Therapies’ draw support from Calyx The company’s medical imaging technology and other eClinical solutions reportedly played a part in half of the treatments to receive the FDA designation. eClinical and regulatory services specialist Calyx reports that its medical imaging services and other eClinical solutions were used in approximately half of the oncology treatments approved by the US Food and Drug Administration (FDA) as Breakthrough Therapies over the past two years. This designation enables the agency to grant priority review to drug candidates if preliminary clinical trials indicate the therapy has potential to offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.