GE HealthCare has delivered the initial subject doses of a positron emission tomography (PET) myocardial perfusion imaging (MPI) agent, Flyrcado (flurpiridaz F 18) injection, to detect coronary artery disease (CAD).
The dosing procedures were conducted at early adopter imaging centres across the US.
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Houston Methodist Hospital was the first to administer the doses in a phased rollout at the centres, including UW Health University Hospital in Wisconsin.
GE HealthCare pharmaceutical diagnostics segment CEO Kevin O’Neill said: “These imaging centres are leading the way in cardiac imaging, and we are pleased they have recognised the impact this diagnostic—which has been called a game-changer—can make both for their clinicians and their patients.”
The development follows Flyrcado’s approval by the US Food and Drug Administration (FDA) for known or suspected CAD detection, in September 2024.
Flyrcado claims to offer a “higher” diagnostic efficacy than the current single-photon emission computed tomography (SPECT) MPI. Its full commercialisation is expected in the second quarter of this year.
With a 109-minute half-life, the agent allows for a broader distribution eliminating the generator maintenance and on-site tracer production requirement.
The company plans to use contract manufacturing organisations’ (CMOs) support to ensure widespread US access to Flyrcado, aiming to reach almost the entire current user base of cardiac PET by the year-end.
GE HealthCare noted that it anticipates receiving pass-through status from the US Centers for Medicare and Medicaid Services (CMS), which will allow for Flyrcado’s separate reimbursement in hospital outpatient settings.
The company is also working with commercial payers to recognise Flyrcado’s value and its potential to enhance patient outcomes.
It was evaluated during the multicentre AURORA Phase III trial, where it was compared against invasive coronary angiography and SPECT MPI.
The agent introduces the first practical option for combining exercise stress testing with cardiac PET imaging for CAD diagnosis.
Earlier this month, GE HealthCare announced a $138m expansion of its contrast media manufacturing site in Carrigtohill, Cork, Ireland.
