GE HealthCare (Nasdaq: GEHC) has received U.S. Food and Drug Administration (FDA) approval for Flyrcado™ (flurpiridaz F 18) injection, marking a significant advancement in positron emission tomography (PET) myocardial perfusion imaging (MPI) for detecting coronary artery disease (CAD). Designed for patients with known or suspected CAD, Flyrcado offers superior diagnostic accuracy compared to the commonly used single-photon emission computed tomography (SPECT) MPI, enhancing both clinician and patient access to PET MPI, especially for those who are difficult to image, such as individuals with a high body mass index (BMI) and women.
With a half-life of 109 minutes—much longer than current PET MPI tracers—Flyrcado eliminates the need for on-site production and generator upkeep, facilitating broader distribution to hospitals and imaging centers. This extended half-life enables the innovative combination of exercise stress testing with cardiac PET imaging for CAD, allowing for a more comprehensive assessment of ischemia in patients. Additionally, clinicians can rescan patients during the same session if technical issues arise, minimizing the need for rescheduled appointments.
Dr. Jamshid Maddahi, MD, FACC, MASNC, the principal investigator of the Flyrcado clinical trials and a clinical professor at UCLA School of Medicine, remarked, “Flyrcado represents a groundbreaking development in nuclear cardiology. While PET MPI is known for its high diagnostic accuracy compared to SPECT MPI, the limited availability of existing PET tracers has restricted its use. Flyrcado has the potential to change that, significantly impacting the diagnosis of CAD, the leading cause of mortality worldwide.”
CAD is the most prevalent heart disease in the U.S., responsible for approximately 695,000 deaths in 2021 alone. The AURORA Phase III trial assessed flurpiridaz F 18 against invasive coronary angiography and SPECT MPI to establish its diagnostic effectiveness for CAD. Each year, around six million MPI procedures are performed in the U.S. to evaluate blood flow through the heart and assess myocardial ischemia or infarction.
Dr. Mouaz Al-Mallah, MD, MSc, MASNC, former President of the American Society of Nuclear Cardiology (ASNC) and Director of Cardiac PET at Houston Methodist Hospital, expressed optimism about Flyrcado’s properties, stating, “Flurpiridaz F 18 offers excellent myocardial uptake and imaging characteristics, making it a promising choice for imaging institutions and patients alike. Its unit dose format and ability to facilitate exercise stress testing could open new avenues for cardiac PET, enhancing patient access to these vital imaging services.”
Kevin O’Neill, CEO of GE HealthCare’s Pharmaceutical Diagnostics (PDx) segment, highlighted Flyrcado’s significance, stating, “As the first and only FDA-approved F 18 PET MPI radiotracer for CAD detection, Flyrcado represents our commitment to innovation in molecular imaging, enhancing diagnostic confidence and addressing critical patient needs.”
Flyrcado is part of GE HealthCare’s expanding portfolio of FDA-approved molecular imaging PET products, joining Cerianna™ (fluoroestradiol F 18) for detecting estrogen receptor-positive lesions in breast cancer and Vizamyl™ (flutemetamol F 18) for estimating beta-amyloid plaque density in Alzheimer’s patients.
In 2017, GE HealthCare acquired exclusive global commercialization rights for flurpiridaz F 18 from Lantheus, overseeing its funding and development until approval. Lantheus will continue to collaborate on commercialization efforts.
Flyrcado is expected to be available in initial U.S. markets in early 2025, with plans for wider distribution thereafter.
As a leader in medical technology and pharmaceutical diagnostics, GE HealthCare is dedicated to advancing molecular imaging equipment and proprietary radiopharmaceuticals across cardiology, neurology, and oncology, supporting over 120 million patient procedures globally each year.
