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MHRA launches Yellow Card ‘biobank’ to learn how genes affect medicines safety

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MHRA launches Yellow Card ‘biobank’ to learn how genes affect medicines safety

The MHRA has teamed up with Genomics England to launch a pilot ‘biobank’ scheme using genetic data and patient samples to understand how a person’s genes affect the safety of their medicines.

The Yellow Card biobank, which will initially focus on rare skin reactions to allopurinol before incorporating other topics, will run alongside the MHRA’s reporting site of the same name, used for adverse incidents and suspected side effects, and is part of a “long-term vision for more personalised medicines approaches,” said the medicines watchdog.

Participating patients will have their blood taken by a nurse in their homes, with the samples sent to the testing facility to be sequenced. All genetic materials will be “de-identified”.

The MHRA said: “Scientists will use the repository of genetic information in the biobank to determine whether a side effect from a medicine was caused by a specific genetic trait.

“This will in turn enable doctors to target prescriptions using rapid screening tests, so patients across the UK will receive the safest medication for them, based on their genetic makeup.”

Knowing more about what causes adverse reactions will also help develop pharmacogenetic testing strategies, it added, providing the “opportunity to prevent rather than react to adverse drug reactions”.

Individuals will be recruited to the pilot from September 1, with genetic sequencing to begin in spring next year and initial findings published in 2025. Genomics England will offer the use of its infrastructure for sequencing and storing genetic material.

MHRA chief executive Dr June Raine said: “Almost a third of adverse reactions to medicines could be prevented with the introduction of genetic testing.

“The biobank will help us move towards our goal of personalised medicine - which, when achieved, means patients across the UK will receive the safest medicine for them, based on their genetic makeup.

“This has the potential to transform our safety monitoring activities – enabling us to meet a real need by using high-quality patient data to reduce side effects of medicines.”

Professor Matt Brown, chief scientific officer with Genomics England, commented: “We are thrilled to embark on this transformative partnership with the MHRA, as we delve into the genomics of severe adverse drug reactions.

“Many of these reactions are influenced by underlying genetic risk factors, substantially heightening an individual’s vulnerability.

“By joining forces with the MHRA, we are poised to gain greater understanding of these genetic influences – discoveries that will be vital if we are to move to harness the power of genomics to proactively protect patients from these harms.”

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