The US Food and Drug Administration (FDA) has given approval toa radioactive diagnostic drugwhich helps detect heart disease more effectively.

GE HealthCare's Flyrcado(flurpiridaz F 18)PET radiotracer thus has become, the first- of- its kind noninvasive diagnostic test to receive approval from the FDA to diagnose coronary artery disease (CAD) in US.

Coronary artery disease (CAD), is caused by accumulation of plaque in the walls of coronary arteries or the main blood vessels that supply blood to heart. CAD killed nearly 695,000 people in US in 2021.

Interestingly, the injection can give higher diagnostic efficacy compared to the single-photon emission computed tomography (SPECT) MPI (myocardial perfusion imaging), the nuclear medicine procedure which is currently used to assess function of heart muscle.

Flyrcado, a positron emission tomography myocardial perfusion imaging (PET MPI) agent, can be produced in an offsite pharmacy and distributed as a ready- to- use unit dose,the company said, adding that the drug can help improve 'diagnostic accuracy' in patients in the 'difficult-to-image' category, mainly those with a high BMI.

The company assessed efficacy of Flyrcado in a phase 3 trial and compared it to the currently used methods- theinvasive coronary angiography and SPECT MPI.

About 74 to 89 percent of the scans were accurately classified withFlyrcado, Reuters reported.

 "As the first and only FDA-approved F 18 PET MPI radiotracer for CAD detection, Flyrcado can make a real difference to clinicians and their patients. This is another example of GE HealthCare's commitment to innovating and investing to shape the future of molecular imaging, increasing diagnostic confidence and addressing unmet patient needs,"Kevin O'Neill, CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare, said in a statement.

Like Flyrcado, the company has two other FDA-approved molecular imaging PET products for breast cancer and alzheimer's.

Flyrcado lasts longer than currently used PET MPI tracers and this feature makes it possible to join exercise stress testing with cardiac PET imaging for CAD, the company said.

It was in April 2017GE Healthcare signed a 'definitive license agreement'with Lantheusfor worldwide development and commercialization of Flurpiridaz F 18. Flyrcado is expected to hit US markets by early 2025.