The U.S. FDA has approved a new positron emission tomography imaging agent for prostate cancer, Blue Earth Diagnostics announced on Tuesday.

Brand-named Posluma is indicated for PET scans of prostate-specific membrane antigen (PSMA)-positive lesions in men with the disease. The imaging agent is targeted toward individuals with metastasized prostate cancer who are either candidates for therapy or have a suspected recurrence based on elevated PSA levels.

Blue Earth Diagnostics, which is part of the larger Bracco, said this is the first and only FDA-approved, PSMA-targeted imaging agent developed with its proprietary radiohybrid technology.

“This event marks a major milestone in the expansion of Blue Earth Diagnostics’ robust prostate cancer portfolio,” CEO David E. Gauden said in a statement issued May 30. “Posluma was developed to assist physicians in the detection and localization of prostate cancer. It represents a new class of purposely engineered, high-affinity, PSMA-targeted radiopharmaceuticals based on novel radiohybrid technology, which may offer diagnostic imaging and therapeutic potential.”

Oxford, England-based Blue Earth Diagnostics will offer the new agent for commercial sale through pharmacies connected with manufacturer and distributor PETNet Solutions, a Siemens Healthineers company. It expects availability to increase in the coming months.

The FDA’s approval follows two phase 3 clinical trials supported by Blue Earth Diagnostics. Results of the experiments demonstrated high specificity for the detection of pelvic lymph nodes compared to the standard histopathologic approach. Researchers also recorded high detection rates (percentage of positive PET scans), even at low PSA levels. Adverse reactions—such as diarrhea, blood pressure increase or injection site pain—were reported in less than 0.4% of cases across 747 patients with initial or recurrent prostate cancer.

In the Blue Earth Diagnostics announcement, radiologist and nuclear medicine specialist David M. Schuster, MD, noted the unpredictable, “highly variable” nature of prostate cancer. Up to 40% of patients who undergo a radical prostatectomy and 50% of those who receive radiation therapy develop recurrences within 10 years, he estimated.

“The ability to determine the extent and location of recurrent disease is necessary to inform physicians and their patients for appropriate clinical management,” Schuster, an Emory University School of Medicine professor and investigator in the phase 3 trials, said in the announcement. Posluma can serve as a “potential decision-making aid in assessing suspected biochemical recurrence of the disease,” he added, noting it notched an overall detection rate of 83%.

The announcement comes as radiology providers have witnessed surging demand for PET after the FDA approved the first commercially available PSMA PET agent two years ago. Experts marked the decision as a significant milestone in medicine, with the Cleveland Clinic labeling PSMA PET as one of the top 10 medical innovations to watch in 2022. A report from IMV released in March also charted 46% year-over-year growth in PET prostate scan volumes, climbing 3 percentage points to account for 9% of the overall procedure mix by study type.