US FDA approves GE HealthCare’s heart disease diagnostic drug by Reuters

(Reuters) – The U.S. Food and Drug Administration has approved GE HealthCare’s (NASDAQ: ) diagnostic drug for use in detecting coronary artery disease, the company said on Friday.

Flyrcado, which is a radioactive diagnostic medicine for positron emission tomography (PET) myocardial perfusion imaging (MPI), will be available in some US markets in early 2025 before being expanded.

PET-MPI is a noninvasive imaging test that uses a type of nuclear medicine called radioactive tracers to assess how well blood is flowing to the heart muscle. 3D images of the tracer distribution can then be produced.

The company said Flyrcado, which can be manufactured in an off-site pharmacy and delivered as a ready-to-use unit dose, has the potential to expand access to PET-MPI, including improving diagnostic accuracy in hard-to-view patients such as those with a high body mass index and women.

Physicians highlighted the distinct clinical benefits of Flyrcado, such as higher quality images, higher defect resolution and improved workflow, brokerage Stifel said in a note ahead of the approval.

Using Flyrcado helped accurately classify 74% to 89% of participant scans in one study.

GE HealthCare said Flyrcado offers greater diagnostic efficacy in patients with known or suspected CAD compared with SPECT MPI, which is the predominant procedure used today.

CAD is the narrowing or blockage of the coronary arteries, which supply oxygen-rich blood to the heart. It affects more than 18 million adults in the US and is the leading cause of death in the country, according to the FDA.

Flyrcado breaks down ten times slower than currently approved cardiac PET radiotracers, GE HealthCare said, which may help combine exercise stress testing with imaging.

The company also has similar products for detecting breast cancer and Alzheimer’s disease.

Stifel analysts estimate the approval of Flyrcado could add about 0.3% to 0.6% to the company’s sales growth over the medium to long term.