Cancer and heart disease: Diagnostic tools get MHRA approval

Two fresh approvals from the Medicines and Healthcare products Regulatory Agency (MHRA) are expected to improve diagnostics for cancer and coronary heart disease (CHD).

The regulator has given the green light to the Rubidium Generator as a diagnostic tool to aid CHD diagnosis.

The Rubidium Generator uses a radiopharmaceutical substance that contains a small amount of radioactivity which can be seen with special cameras from outside the body, ultimately helping healthcare professionals gain insight into blood flow to the heart.

This, in turn, helps diagnose or assess suspected and known CHD cases. CHD is responsible for 68,000 deaths a year in the UK.

Commenting on both approvals, MHRA healthcare quality director, Julian Beach, said: “Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.

“We’re assured that the appropriate regulatory standards for the approval of this diagnostic have been met.”

A second approval comes in the form of piflufolastat as a diagnostic tool for prostate cancer.

The innovation works as a single injection into the patient’s arm, which is then followed up by a PET scan 90-120 minutes later.

Piflufolastat binds to a protein known as PSMA that is commonly found in prostate cancer cells – doctors then use the small amount of radioactivity produced by piflufolastat to identify where prostate cancer cells are located.

“As with all products, we will keep its safety under close review,” added Julian Beach.

Image credit: iStock

NHE March/April 2024

NHE March/April 2024

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