Diagnostics are slowly but increasingly moving out of central labs, with new tests and systems finding their way into hospital wards, physicians’ offices and ambulances. But that’s not the end of this trend. Diagnostics are now moving into patients’ homes and expanding beyond established areas such as diabetes testing, pregnancy and Covid.
In the fullest sense, ‘home diagnostics’ refers to situations where a sample is taken, the test performed, and a result delivered all within the home. It can also encompass scenarios where the sample is taken in the home and then sent for testing at a central lab facility.
Different models for home testing
Many healthcare systems are actively moving testing and treatment away from central facilities such as large hospitals and moving it nearer the patient in their community or home.
For example, one of the three pillars of the UK’s NHS 10 Year Plan published in July 2025 envisages healthcare taking place as locally as possible up to and including in the patient’s home.
In addition to healthcare system mandated testing, there is an increasing appetite for consumer-led testing. For example, testing may enable considered choices in exercise, food or nutritional supplements. Home testing is also often sought out directly by consumers where traditional diagnostics or healthcare access routes are letting them down.
Gestational diabetes: reducing waiting times and testing burden
One of the many diagnostic tests pregnant women may need to take is for gestational diabetes – a rise in blood sugar that can occur in pregnancy, and which can cause a variety of complications.
Traditionally, at-risk women are asked to attend a healthcare facility for an oral glucose tolerance test (OGTT). This means fasting for 8–10 hours, having a blood test, ingesting a glucose solution, followed by another blood test 2 hours later. This is not only inconvenient, but if the clinic is some distance away, then it can become expensive too, putting off some pregnant women from taking the test at all.
UK-based Digostics has developed a home-based OGTT kit. The test essentially works as described above, with a fingerprick blood sample being taken, tested, and the user reporting the results of the test via smartphone or in the post.
A number of trials have been conducted in the UK, with positive feedback from patients and healthcare professionals alike, leading to introduction of the test in some regions of the UK. A further trial is underway in the US for type 1 diabetes evaluation in children, for whom hospital-based OGTT testing is often a significant burden.
Sexually transmitted infections: improving screening rates
The screening rates for sexually transmitted infections (STIs) are often frustratingly low, due to factors such as embarrassment and inconvenience of attending an in-person appointment, and the fact that some STIs present with minimal or no symptoms.
These barriers to testing are being addressed. In November 2023, the FDA granted marketing authorisation to the first diagnostic for chlamydia and gonorrhoea with at-home sample collection.
And an entirely at-home test for chlamydia, gonorrhoea and trichomoniasis in adult females was authorised in March 2025. This test kit and device, produced by Visby Medical, includes a vaginal self-sampling swab, a powered testing device, and an accompanying smartphone app. In individuals with and without symptoms, the test had specificity and sensitivity of >95% for the three conditions, a performance comparable with central lab testing.
More recently in late 2025, the FDA approved a one minute home test for HIV. The INSTI test developed by bioLytical Laboratories gained WHO prequalification in 2018 and was subsequently granted FDA Breakthrough Device status. It is hoped that this highly accessible and portable test will break down barriers to testing and further reduce HIV transmission.
Inflammatory bowel disease: simplifying monitoring during long-term treatment
Inflammatory bowel disease (IBD) is an autoimmune condition that can cause stomach upsets, extreme tiredness, weight loss and abdominal pain, as well as being associated with an increased risk of bowel cancer. Various treatments for IBD may be either taken long-term or only used during ‘flare-ups’ of the condition.
The responses of patients to these treatments are typically monitored by symptom questionnaires, endoscopy or central lab testing for biomarkers. However, having to attend healthcare facilities is inconvenient for patients, and can mean that they’re not monitored as often as they should be.
Various home testing devices for IBD are now available in the EU. Most consist of a stool sample collection device, a lateral flow assay, and a smartphone app that is used to read the test result. Studies show good agreement with central lab results, which is encouraging more patients to engage with this way of managing their condition.
Respiratory tract infections: taking testing from the pandemic into general usage
The Covid-19 pandemic showed that people are willing to engage with self-testing for infectious diseases and take actions to help themselves and protect others. In the US, those tests were approved by the FDA under the ‘emergency use’ pathway.
Since then, the first over-the-counter home diagnostic test for Covid-19 and influenza A & B, manufactured by Healgen Scientific, was approved in October 2024 via the premarket approval pathway, meaning that such tests can be bought without prescription and used at home.
In effect, the FDA has created a new regulatory classification meaning that similar devices targeting the same pathogens can now proceed along the less burdensome 510(k) pathway. Indeed, a number of similar devices have received FDA clearance more recently.
Cervical cancer: rolling out at-home sample collection
Vaccination and screening have greatly reduced cervical cancer incidence, but there remains a need to improve screening rates. The vast majority of cases are caused by the human papilloma virus (HPV), making it possible to screen for cervical cancer by testing for this pathogen, rather than by cumbersome cytological tests.
The WHO has recognised self-sampling for HPV as an effective strategy that has been rolled out in several countries, either as the primary screening tool or in conjunction with more centralised programmes.
In May 2025, the FDA approved a vaginal sample self-collection device from Teal Health, who are in the process of rolling out the device across the US.
More recently in April 2026, the second such device gained FDA approval: the Waters Corporation Self Collection Kit can be used in combination with BD’s Onclarity HPV assay.
Novel sample collection devices
As one might expect, the recent expansion of home testing has been primarily directed at samples that are easy to access and collect. These encompass swabs and readily accessed body fluids such as saliva or urine.
However, recent developments in sampling devices may enable the expansion of home testing into yet more areas of health.
Some home testing can be achieved with only the small amount of blood produced by a finger prick. For example, diabetics will be very familiar with this procedure. Other tests require larger volumes of blood than can be supplied by a finger prick sample. This barrier to home testing is now being surmounted by novel blood sample collection systems.
Devices such as the Tasso+, the RedDrop One and Drawbridge Health NanoDrop, all approved in the USA, can sample approximately half a millilitre of capillary blood from the upper arm using integrated lancets and deposit the sample in a tube that forms part of the apparatus. These devices also have features allowing safe disposal and avoidance of unintentional injury from the lancet.
The potential of devices such as these for home-based testing is clear, and we anticipate an expansion in coming years. They may be combined with a send-away central lab testing model: For example, in the UK, Randox Health, a leading provider of home testing products launched a collaboration in 2023. Alternatively, such devices may also be used as part of an entirely at-home test procedure.
Regulatory and funding challenges for home diagnostics
Many of the home diagnostics above are provided and used with the oversight of a health professional or formal screening programme. Others can be purchased directly by the consumer from pharmacies, supermarkets or online.
Direct-to-consumer tests can have great advantages such as facilitating access to healthcare, removing burdens to testing and allowing people to actively manage their own health. However, there can also be downsides. With no oversight by a healthcare professional, tests that are inappropriate to the person’s circumstances can be purchased and used leading to unhelpful results.
The regulatory environment surrounding home testing varies by country but ensuring patient safety while maximising the benefit of home testing is a challenge that must be met by all. Increasing use of home diagnostics by the medical profession is likely to stimulate further demand for other types of test and regulators need to be ahead of the challenges this will bring.
Other considerations for the increasing use of home diagnostics in healthcare are how they are funded and how they are integrated with more traditional models of healthcare. Whether in an insurance-based system or a more centralised state healthcare provider, old models of funding tests via central labs do not work for home testing. Additionally, for results to be acted upon they must be accessible to clinicians and therefore integrating test results into electronic health records will be key for increased use of home testing.
Despite these challenges, home testing can bring great health benefits on both a personal and a population level so insurance companies, reimbursement schemes and national bodies will need to adapt to keep pace.
Developing successful home diagnostics
The adoption of home diagnostics is gathering pace, with the main driver being convenience, leading to improved adherence, increased frequency of testing, without reliance on centralised healthcare resources. Nevertheless, the development of a successful home diagnostic means that manufacturers need to overcome a complex set of challenges.
Home tests must achieve near to central-lab quality without being unfeasibly expensive or complex for the individual to perform. Systems needed to process the sample must be suitable for the home environment; and results need to be interpretable by the patient and often shared with healthcare providers via smartphone. This brings many complex assay integration, design and engineering challenges.
Devices for self-sampling and sample collection not only need to be safe and effective but also need to be accepted by patients. If samples are to be sent away, they must remain stable without refrigeration and also be protected from damage during transport to the testing location. Finally, consumers are becoming more and more concerned about non-recyclable waste materials, which creates another set challenges for device design.
TTP offers a long track record in the end-to-end development of point-of-care diagnostic systems and medical devices for the home. You can read more about our risk-based process for overcoming these challenges in medical device development in our recent whitepaper, available here.
Working with the TTP Diagnostics Team
When developing next-generation in vitro diagnostic (IVD) systems, whether for point-of-care or distributed testing, success depends on delivering a product that works in practice, not just in concept.
We bring decades of experience in designing and delivering complex, regulated diagnostic systems. By integrating assay, hardware, software, and manufacturing from the outset, we take responsibility for the system working as a whole. This reduces risk, avoids rework, and accelerates the delivery of a deployable product.
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