Marlborough, US – June 4, 2024 – In a GE HealthCare sponsored pharmaco-economic study published in peer-reviewed journal PLOS ONE, the incidence, prevalence, diagnostic pathways, and treatments of different patients with metastatic or recurrent breast cancer were analyzed using a combination of widely accepted statistical modelling methods to estimate the clinical and associated economic impact of adding a PET/CT scan with [18F]FES, a breast oncology PET tracer, to the current standard diagnostic process.

Breast cancer is the most diagnosed cancer worldwide, with approximately 2.3 million new cases appearing in 2020 alone.[3] Correct identification of the receptor status in breast cancer is crucial to optimize treatment; however, the diagnostic standard of care which involves biopsy/IHC and imaging, can yield inconclusive results. [18F]FES can be a powerful tool, providing high diagnostic accuracy in detection of estrogen receptor (ER)-positive lesions. The study demonstrated that adding a PET/CT scan with [18F]FES to biopsy/IHC may increase the diagnostic accuracy of the ER status in all appropriate patients with metastatic or recurrent breast cancer. The clinical and economic benefits were especially pronounced in those situations where a tumor sample cannot be obtained, or the risk of a biopsy-related complication is high.

Regina Young, Head of Global Market Access in the Pharmaceutical Diagnostics segment of GE HealthCare and lead author of the study said, “We found that if [18F]FES PET/CT was added to the standard diagnostic work up and in line with the Appropriate Use Criteria (AUC) for ER-targeted PET Imaging,[4] the increase in diagnostic accuracy could improve the clinical outcomes. Additionally, results suggested a positive correlation between increased diagnostic accuracy, especially when multiple lesions are present,” said Young. "The increase in true ER-positive and ER-negative results may have beneficial clinical and economic outcomes primarily driven by the avoidance of repeated biopsies and futile treatments.”

In 2023, FES PET imaging was added to the National Cancer Care Network (NCCN) Clinical Practice Guidelines in Oncology for ER-positive disease under certain circumstances during the systemic staging workup of patients with metastatic and recurrent breast cancer. This inclusion came after the Society of Nuclear Medicine and Molecular Imaging (SNMMI) published its AUC to guide referring and imaging physicians in appropriate use of ER-targeted PET imaging with 16α-18F-fluoro-17ß Fluoroestradiol. According to SNMMI, the inclusion of FES PET in its AUC is intended to help healthcare practitioners provide patients with the best care in a cost-effective manner. The AUC may also enable more efficient approval of FES use by payers.[5]

GE HealthCare’s Cerianna is the only FDA-approved FES PET imaging agent. Cerianna is indicated for use with PET imaging for the detection of ER-positive lesions as an adjunct to biopsy in patients with metastatic and recurrent breast cancer. Providing a whole-body view of ER-positive lesions, Cerianna may deliver a comprehensive assessment to assist in making an informed diagnosis and individualized treatment plan for the patient.

GE HealthCare’s Pharmaceutical Diagnostics segment is a global leader in imaging agents used to support around 119 million procedures per year globally, equivalent to four patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology, and oncology, with an innovative pipeline, all aimed at enabling better-informed diagnosis and monitoring for improved therapy decision-making and clinical outcomes.

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