Feb. 25, 2025— GE HealthCare has delivered the first patient doses of Flyrcado (flurpiridaz F 18) injection, a unit dose positron emission tomography myocardial perfusion imaging (PET MPI) agent for detecting coronary artery disease (CAD), at early adopter imaging centers in the US. This follows the recent FDA approval of Flyrcado, which is indicated for patients with known or suspected CAD, and delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI..
Dr. Mouaz Al-Mallah, MD, MSc, MASNC, Director of Cardiac PET at Houston Methodist Hospital, said, “Flyrcado opens new frontiers for cardiac PET with a significantly longer half-life than existing PET MPI tracers, and we are proud to be one of the first to use it in our cardiac PET lab. The longer half-life eliminates the need for onsite tracer manufacturing so it can be ordered as a ready-to-use unit dose. Additionally, it offers clinicians the flexibility to perform exercise stress testing—something not feasible with any previously available cardiac PET tracer. We anticipate Flyrcado will make PET MPI more accessible to clinicians and patients and allow more centers to provide this important imaging modality to appropriate patients.”
In February, Houston Methodist Hospital delivered the first doses in a phased rollout of the cardiac PET agent at early adopter imaging centers nationwide, which includes UW Health University Hospital in Wisconsin. Full commercialization of the radiotracer is anticipated in the second quarter of 2025. With a half-life of 109 minutes, — Flyrcado removes the need for on-site tracer production and generator maintenance and enables distribution to a wide network of hospitals and imaging centers. GE HealthCare will be supported by contract manufacturing organizations (CMOs) to expand coverage across the US to enable regional access to Flyrcado and expects to be able to reach nearly all of the existing cardiac PET user base by the end of 2025.
“The first patient doses of Flyrcado mark a significant milestone in the journey of this product which has been more than a decade in the making,” said Kevin O’Neill, CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare. “These imaging centers are leading the way in cardiac imaging, and we are pleased they have recognized the impact this diagnostic—which has been called a game-changer—can make both for their clinicians and their patients. We are committed to growing the manufacturing footprint for Flyrcado to drive access for cardiac PET-enabled imaging centers throughout the US.”
CAD is the most common form of heart disease and remains the leading cause of death for men and women in the US, with 371,506 deaths reported in 2022[1]. During the multicenter international AURORA Phase III trial, flurpiridaz F 18 was compared with both invasive coronary angiography as a standard of truth to determine diagnostic efficacy in detecting CAD, as well as with SPECT MPI. Around six million MPI procedures are undertaken each year in the US[2] to show blood flow through the heart muscle and evaluate the presence, extent and degree of myocardial ischemia or infarction. Flyrcado brings the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD, enabling the most robust protocol for evaluating ischemia in patients.
GE HealthCare will mark the commercial launch of Flyrcado at the annual American College of Cardiology congress in Chicago from March 29-31, 2025, and expects to receive pass-through status from the US Centers for Medicaid and Medicare (CMS) shortly thereafter, enabling separate reimbursement for Flyrcado in the hospital outpatient setting.
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National Center for Health Statistics. Multiple Cause of Death 2018–2022 on CDC WONDER Database. Accessed May 3, 2024. https://wonder.cdc.gov/mcd.html
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Miller, R. J. H., Bednarski, B. P., Pieszko, K., Kwiecinski, J., Williams, M. C., Shanbhag, A., Liang, J. X., Huang, C., Sharir, T., Hauser, M. T., Dorbala, S., Di Carli, M. F., Fish, M. B., Ruddy, T. D., Bateman, T. M., Einstein, A. J., Kaufmann, P. A., Miller, E. J., Sinusas, A. J., Acampa, W., Han, D., Dey, D., Berman, D. S., & Slomka, P. J. (2024). Clinical phenotypes among patients with normal cardiac perfusion using unsupervised learning: A retrospective observational study. EBioMedicine, 99, 104930. https://doi.org/10.1016/j.ebiom.2023.104930
November 07, 2024 
