GE HealthCare receives FDA approval for Flyrcado PET radiotracer, set to transform coronary artery disease diagnosis

GE HealthCare has received the US Food and Drug Administration (FDA) approval for Flyrcado (flurpiridaz F-18), a breakthrough PET radiotracer poised to transform the diagnosis of coronary artery disease (CAD). This novel radiopharmaceutical offers higher diagnostic efficacy compared to the current standard, single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI). CAD remains the leading cause of death in the United States, making improved diagnostic tools like Flyrcado crucial for early detection and treatment.

Flyrcado stands out due to its longer half-life of 109 minutes, significantly longer than existing PET tracers. This extended half-life allows for broader distribution across imaging centers, which could increase access to PET MPI for many patients, particularly those in underserved areas. The drug’s ability to be manufactured offsite and delivered as a ready-to-use dose eliminates the need for costly on-site production, a major barrier to wider adoption of PET imaging technology.

Clinical trials have demonstrated that Flyrcado outperforms SPECT in detecting CAD, particularly in patients with higher body mass index (BMI) and women, populations often challenging to image effectively with traditional methods. Flyrcado also facilitates exercise stress testing during PET imaging, providing a more comprehensive diagnostic protocol for evaluating ischemia. Furthermore, the reduced radiation exposure associated with Flyrcado PET—up to half that of some SPECT tracers—adds another layer of benefit for patients undergoing repeated scans.

Experts in nuclear cardiology have hailed Flyrcado as one of the most significant advances in the field over the past few decades. Dr. Jamshid Maddahi, principal investigator of the clinical trials, emphasized its potential to address current limitations in PET MPI access and accuracy, predicting a shift toward wider adoption of PET imaging in nuclear cardiology. He noted that the precision and diagnostic clarity Flyrcado offers could change the course of patient care, especially for those whose SPECT scans had previously shown inconclusive results.

In addition to expanding access to PET imaging, Flyrcado also paves the way for economic efficiency. The ability to order unit doses as needed—rather than maintaining expensive rubidium-82 generators—could encourage more imaging centers to invest in PET technology, ultimately benefiting both clinicians and patients.

Flyrcado’s approval adds to GE HealthCare’s portfolio of PET imaging agents and reinforces the company’s position as a leader in medical diagnostics. The drug is expected to be available in U.S. markets by early 2025, with wider distribution to follow as more centers adopt this groundbreaking technology.