Dive Brief:
- GE Healthcare received Food and Drug Administration approval for a new imaging agent with a longer half-life for use in positron emission tomography (PET) scans to detect coronary artery disease.
- The agent, called Flyrcado (flurpiridaz F 18), offers higher diagnostic efficacy than the current standard of care procedure in nuclear cardiology and could expand access to PET myocardial perfusion imaging (MPI) because it is more convenient to use, the company said Friday.
- “I am excited for this new radiotracer and its potential impact, as a game changer, for diagnosing the disease with the highest mortality rate in the world,” Jamshid Maddahi, professor at the University of California Los Angeles School of Medicine and principal investigator of the Flyrcado clinical trials, said in a statement.
Dive Insight:
PET MPI testing is used to determine how well blood is flowing through the heart. The scan uses a radioactive drug called a tracer to show areas that are not getting enough blood flow.
The procedure’s higher diagnostic efficacy, compared to the standard MPI method, could help improve accuracy for patients with a high body mass index and women who are more difficult to image.
However, MPI is currently used in a minority of PET scans in the U.S. because of limited access to available tracers.
Flyrcado’s half-life of 109 minutes is significantly longer than that of existing PET MPI tracers, GE Healthcare said, which means it can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose. This removes the need for on-site tracer production and generator maintenance, opening up distribution to a wide network of hospitals and imaging centers.
The longer half-life also allows clinicians to combine exercise stress testing with cardiac PET imaging for coronary artery disease or rescan a patient during the same imaging session if needed, the company said.
Stifel analyst Rick Wise predicted quick uptake of the new imaging agent among U.S. cardiac PET centers due to strong interest from doctors.
“Following our extensive physician due diligence over recent months, it seems clear that … [Flyrcado] offers meaningful clinical improvements compared to other MPI radiopharmaceuticals,” Wise wrote in a note to clients on Sunday.
GE Healthcare said it led funding and development of the product after acquiring exclusive global commercialization rights from Lantheus in 2017. The company added that Flyrcado will roll out in initial U.S. markets in early 2025.