Following the BBC's report on PSA home testing kits on 5th March 2025, we too acknowledge the need for robust standards within the UK self-testing market. We affirm that SELFCHECK PSA tests are scientifically validated, independently certified by a Notified Body, and fully compliant with UK medical device regulations. Our products are registered with the MHRA specifically for public self-testing.
We are particularly concerned by the sale of hospital-only PSA tests directly to the public, companies involved in this practice are circumventing the stringent UK regulations designed for self-testing. This practice is unacceptable. Such actions undermine the rigorous standards we uphold and potentially endanger public safety.
SELFCHECK, a UK-based company, has invested significantly in:
- Premium medical components manufactured for us by our UK and European partners
- Implementing a gold-standard, independently audited quality assurance system for medical device design and manufacture
- Providing expert, professional customer support
- Ensuring clear, accessible instructions, despite regulatory pressures for technical jargon
We prioritise transparent communication regarding the limitations of PSA testing, reflected in our packaging and website information. We advocate for informed consumer choice, providing clear, factual information rather than underestimating public understanding.
We contest the assertion that self-test blood tests are inherently difficult to use. Regulatory approval mandates rigorous user trials with laypersons. We provide a dedicated helpline to address user queries and ensure correct test administration.
All medical tests, including clinical, laboratory, and self-tests, carry inherent limitations. False positive or negative results can occur, often due to biomarker relevance rather than device design. We emphasise that elevated PSA levels can stem from conditions other than prostate cancer, and this information is clearly presented.
Self-test kit evaluations require extensive performance studies, often involving thousands of tests, before regulatory submission and certification. An analysis of just one device lacks scientific validity.
Self-testing kits that need blood are designed to use finger-prick whole blood samples. As the blood is applied immediately to the test device, no anticoagulant is needed. Unless stated otherwise, utilising anticoagulated laboratory blood is scientifically unsound and outside the intended use. Clinicians and laboratory professionals are well aware of the critical blood collection requirements for different analytes and devices.
Our concerns for the future
As experts in medical diagnostics, and in response to requests from the NHS, we are developing next-generation PSA tests in our North Wales laboratories. This research is funded by ourselves.
We are deeply concerned that unregulated sales and a lack of understanding of medical device regulations among some journalists, scientists, and clinicians, will hinder innovation and undermine public confidence in future health testing advancements in the UK.
We must ensure that innovation is not stifled by misinformation and that the public can benefit from the next generation of PSA testing.
Further information on SELFCHECK can be found here