SciBase Holding AB ("SciBase") (STO: SCIB), a leading developer of AI-based diagnostic solutions for skin disorders, announced that it has received approval by FDA for its supplement to extend the labelling to include other healthcare professionals and not only dermatologists to perform the Nevisense procedure.

Previously, the labelling only specified dermatologists as users but now it also includes healthcare professionals such as physician assistants and medical assistants working at dermatology clinics. A dermatologist still needs to initiate the test, but the actual measurement can now be performed by other healthcare professionals. This means that Nevisense now much easier can be integrated into a clinic's workflow thus potentially expanding SciBase customer utilization and easier access for patients. 

"This is an important extension of our labelling as it makes it easier to integrate EIS and Nevisense into a clinic's workflow and becoming a part of the melanoma decision pathway. It also means that labs that perform tests now can include Nevisense in their offering. The expanded labelling and the recently published NCCN guidelines together with our ongoing reimbursement work gives me confidence regarding our US potential and growth," said Pia Renaudin CEO of SciBase.