Israeli radiopharmaceutical firm Isotopia Molecular Imaging's Isoprotrace PSMA-11 kit has received marketing authorization in the Netherlands.
Isoprotrace is designed for prostate cancer patients and is indicated for PET imaging, for primary staging of those with high-risk prior to primary curative therapy, and for patients who have suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Isoprotrace is a single sterile vacuum-vial kit, intended for preparing multi-patient doses of gallium-68 (Ga-68) gozetotide (PSMA-11) within five minutes.
Isoprotrace is pending approval for similar authorization in Germany, the company said.
