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YellowCard
Making medicines and medical devices safer

Biobank

About Yellow Card biobank

Yellow Card biobank is a collaboration between the MHRA and Genomics England. Its goal is to improve understanding of how a patient’s genetic makeup may increase their risk of harm from side effects.

By collecting genetic samples from patients who have experienced suspected side effects, the Yellow Card biobank will create a repository of genetic information that can be used to help determine whether a suspected side effect was caused by a specific genetic trait.

It is hoped the research generated from this resource will enable development of interventions such as screening tests for patients that can be used by healthcare professionals to personalise medical treatment to individuals, according to their genetics. For example, more information about how people with a certain genetic make-up have responded to medicines in the past, will enable healthcare professionals to prescribe the most effective and lowest risk medication to patients with similar genetics, and will allow patients at a low risk of harm to maintain access to medicines they need.

The initial phase of the project will concentrate on a medicine called Allopurinol, used to treat gout, kidney stones and other types of kidney problems, and the related rare side effect of severe skin reactions, including Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). More topics for the pilot phase will be confirmed soon.

Genomics England will work alongside the MHRA to sequence and store genetic material using their established infrastructure. See our press release

biobank

How to participate

If you are a healthcare professional who has submitted a Yellow Card report on behalf of a patient and the report is relevant to one of the research topics in the pilot, we may ask for your assistance contacting the patient to see whether they would be interested in participating.

If you are a patient who has submitted a Yellow Card report that is relevant to one of the research topics in the pilot, we may follow up with you directly to determine your interest in volunteering to participate. Participating patients will receive a home visit from a nurse, who will then take a blood sample to be added to the biobank. Participants’ data will be de-identified and stored in the Genomic England secure research environment. Researchers accessing data will have no way of identifying individual participants.

If you would like more information about Yellow Card biobank recruitment then you can email us at: yellowcardbiobank@mhra.gov.uk