The pioneering Yellow Card Biobank, a pilot launched by the Medicines and Healthcare products Regulatory Agency (MHRA) and Genomics England, will today start investigating a new group of medicines used to prevent strokes known as Direct Oral Anticoagulants.
The Yellow Card Biobank aims to help understand how a patient’s genetic makeup can impact the safety of their medicines and forms part of a long-term vision for more personalised medicine approaches. Approved scientists will use the genetic information in the Biobank to investigate whether a side effect from a medicine was caused by a specific genetic trait. This would in turn enable healthcare professionals to personalise prescriptions using rapid screening tests, so patients across the UK will receive the safest medication for them, based on their genetic makeup.
Adverse Drug Reactions (ADRs), or side effects, continue to be a significant burden on the NHS and account for one in 16 hospital admissions. These screening tests would therefore provide the opportunity to prevent these adverse drug reactions from happening.
The MHRA is asking anyone who has experienced excessive bleeding following the use of Direct Oral Anticoagulants to report it to the Yellow Card scheme. Patients who submit Yellow Cards (or have submitted one previously) may be contacted to ask if they would consent to providing further information and submitting a small blood sample. This information will then be used to explore whether some people are at a higher risk of excessive bleeding due to their genetic makeup, with the overall aim of reducing the occurrence of serious side effects.
Dr June Raine, the MHRA Chief Executive, said:
We are excited to launch the second phase of the Yellow Card Biobank, which demonstrates that we are at the absolute forefront of innovation in the field of drug safety monitoring.
Almost a third of adverse reactions to medicines could be prevented with the introduction of genetic testing. The Yellow Card Biobank will help us move towards our goal of personalised medicine.
Getting involved with this important initiative means you will help more people use medicines safely.
Professor Matt Brown, Chief Scientific Officer at Genomics England, said:
We are delighted to be taking this next step in our partnership with the MHRA towards harnessing the power of genomics to break new ground in medicine safety.
Many adverse drug reactions are influenced by underlying genetic risk factors. We hope that through the Yellow Card Biobank pilot we will gain a deeper understanding of these genetic influences that in turn could help patients to receive the best and safest treatment possible.
The Yellow Card Biobank launched in June 2023. The initial phase of the pilot started with a medicine called Allopurinol and related rare severe skin reactions, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Participant recruitment for both topics is now underway.
The sequencing of the participants’ genetic material will begin in Spring 2024, with initial research findings from the pilot expected in 2025. Genomics England is collaborating with the MHRA providing the sequencing and storage of genetic material through use of their well-established and secure infrastructure.
Patients who get involved will be visited at home or at another location convenient for them by a nurse, who will then take a small blood sample to be added to the Biobank and sequenced. Participants’ data will be de-identified and added to the National Genomic Research library, a platform that allows approved researchers to access genomic and other associated health data via a secure research environment.
Those that would be interested in getting involved should visit the Yellow Card Biobank page for future updates between now and the end of the pilot phase in late March 2025.
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Yellow Card Biobank page
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Notes to editors
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- Genomics England is a company established and wholly owned by the Department for Health and Social Care.
- This project forms part of the Government’s Life Sciences Vision.
- For media enquiries, please contact the [email protected].