Company Case Studies - Navigating Regulatory Hurdles

Regulatory hurdles for startups in home diagnostic technologies can make or break the company. Regulatory navigation is paramount for success.

Though the impact of at home diagnostics can be transformative and conveniently detect for cancer and chronic diseases. Development timelines must keep in mind EU, UK and US regulations and their robust clinical evidence requirements. Startups must navigate regulations like the EU In Vitro Diagnostic Regulation (IVDR) and Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.

To better understand what causes success and failure, I have delved into some UK and EU based companies (and one US example that attempted to enter the EU/UK market) all with the intended use of at home urine testing for cancer or chronic disease detection. Healthy.io, TestCard, The Blue Box, Testmate Health and an unsuccessful company Scanadu / Inui Health.

For conclusions please scroll past company overviews and timelines.

Healthy.io (Smartphone Urinalysis for Chronic Kidney Disease)

Healthy.io is a health care company offering remote clinical testing and services enabled by smartphone technology. Launched in 2013 by Yonatan Adiri, the company uses smartphones to enable at home diagnostics testing for the detection of signs of kidney disease, urinary tract infections and pregnancy complications.

Timeline

2013 – Company Founded2018 – Healthy.io’s kidney test becomes the first smartphone based system to receive U.S. FDA clearance (Class II) as a clinical diagnostic [1]. Clinical trials for FDA show its at home ACR testing was as accurate as lab testing. In Europe it obtained CE marking under the old IVDD enabling pilot deployments.2019 – UK pilots begin. A study showed mailing ACR kits to hypertensive patients dramatically increase screening uptake from 0% to 79% in one trial [2]. Healthy.io joins the NHS innovation Accelerator and Greater Manchester Digital Health Accelerator [3].2020 – Raised ~$95 M in funding and during the COVID-19 lockdown, its app was used in the UK for remote monitoring of patients. In June 2020 Healthy.io acquired Inui Health for $9 M to strengthen its IP and U.S. regulatory position [4].2021 – Wins a major UK government contract. Through the NHS AI in Health and Care Award, NHSX supports rolling out Healthy.io’s home ACR testing to 500,000 patients over 3 years [2].2022 – They are currently working on IVDR compliance and transitioning to the new EU regulation by 2026.

TestCard (Smartphone Urine Testing for UTIs and More)

TestCard is a digital platform technology that turns a camera-enabled smart device into a clinical-grade scanner, allowing accurate reading, recording, and reporting of test results. They offer an at-home urine test kit for UTIs as well as support clinical trials (partnership with Yorkshire Cancer Research) through their technology.

Timeline

2017 – Company founded by Dr. Andrew Botham and Luke Heron. Early prototypes of a foldable urine test card were developed.2018 – Company raise a seed round of £1.25 m and entered accelerators [5]

2019 – The company gained visibility by winning the NHS Pitchfest competition helping to attract investors. Closing a £4.5 m funding round to support expansion [6].

2021 – TestCard secured retail and pharmacy distribution deals for its UTI kit. Partnering with Superdrug Online Doctor, Lloyds Pharmacy, Boots, Amazon and NHS online services [7]. This allowed consumers to buy the kit directly or get it through online pharmacies, then use the app to get immediate results and prescription advice. TestCard also deployed its platform in clinical settings for COVID-19 testing. The app was adapted to scan rapid antigen tests (ClearScreen).

2022 – They raised an additional $10 M to fuel growth and developed a diabetes urine test, chronic kidney disease test and others. They also initiated U.S. FDA approval efforts for the UTI product aiming to launch there by 2023. TestCard’s UTI kit was also selected for an NHS funded bladder cancer screening trial – the YORKSURe Trial to allow older adults to self-test for haematuria (blood in urine) as an early bladder cancer indicator.

2023 - TestCard awaited FDA clearance (the process took longer than hoped, partly due to stringent accuracy requirements for home diagnostics). Meanwhile, it continued European sales under its existing CE mark. However, with IVDR now in effect, TestCard had to transition its technical files to meet the new regulation. The UTI test, previously CE-marked as a self-test, was likely considered a Class C device under IVDR (since UTIs are not life-threatening but do require intervention). The company worked with a notified body to certify under IVDR before its CE certificate expiration (legacy certificates for Class C self-tests can remain valid until May 2026 if proper steps are taken [8]. In the UK, TestCard planned to affix the UKCA mark by the extended 2025/2026 deadline for IVDs, leveraging the UK’s recognition of existing CE marks in the interim.

The Blue Box (Urine-Based Breast Cancer Screening)

The Blue Box is a Spanish startup developing a novel urine biomarker test for early breast cancer detection [9]. It aims to offer pain free, radiation free screening as an alternative to mammograms. The solution is a small blue box device in which the user inserts a urine sample into the device and uses an electrical nose to detect the signature of breast cancer metabolites and an AI algorithm to interpret the results via a smartphone app. The device costs ~$60 dollars and avoids the discomfort and accessibility issues of mammography.

Timeline

2017 – Judit Giró develops the first protype as a biomedical engineering thesis at University of Barcelona. She tested on ~90 urine samples with 75% sensitivity in distinguishing cancer vs. control.2019 – As a graduate student at the University of California Irvine, she collaborates with Billy Jurksaitis to build a second prototype with enhanced AI cloud analysis giving >95% classification accuracy in a small sample set.

2020 – The Blue Box wins the James Dyson Award for innovation which brings media attention and seed funding opportunities [10]. The team outlines the next steps: patenting the technology, expanding clinical trials to a few hundred patients, and obtaining regulatory approval.

2021 – Company formally established and move back to Barcelona. Initial Seed funding ~$2 m raised from Spanish and European grants and investors. They begin larger clinical studies in collaboration with hospitals in Spain – collecting urine from breast cancer patients and controls to refine their AI model and validate the sensor array’s accuracy. They reported an improved sensitivity of 88.4% for breast cancer detection which exceeds that of standard mammography (~75 – 85% for young women)

2022 – 2023 - Ongoing R&D and regulatory preparation. Due to the Blue Box’s technology which is a combination of a medical device and AI diagnostics, it potentially falls under Class C IVD in the EU. This means they need a Notified Body to certify it under IVDR, with the team working on generating the clinical performance data required.

2024 – 2025 – Currently the Blue Box is pursuing the necessary certification to allow limited market release. The plan is to have the test available through doctors, with full direct to consumer rollout if the initial deployment is effective. i.e. a woman provides a urine sample at her gynaecologist’s office or via a mailed kit, and the Blue Box device analyses it either in clinic or at home with medical oversight (video call). The company will also have to navigate the UK regulations, given the Windsor Framework in Northern Ireland they would accept the EU CE-IVDR mark but for the island of Great Britain a UKCA marking is required.

Testmate Health (At-home Urine Test for STIs)

Testmate Health is a Swiss startup tackling sexually transmitted infections (STIs). Founded in 2020 by Dr. Siew-Veena Sahi a sexual health diagnosis expert. Testmate is developing the first rapid at home urine test for multiple STIs aiming to make screening as simple and routing as a home pregnancy test focusing on Chlamydia and Gonorrhoeae as well as branching out in analysing Trichomoniasis and Mycoplasma genitalium [11]. It uses advanced DNA isothermal application and microfluidics to detect pathogen DNA in urine.

Timeline

2020 – Company is founded. Initial R&D begins driven by Dr. Sahi’s WHO research that highlighted the need for cheap, rapid STI tests [12]. The concept is a paper-strip DNA test in a handheld format.

2021 – Testmate wins the W.A. de Vigier Award a prestigious Swiss startup prize, validating its approach and providing a non-dilutive funding boost. The team continues to refine the design and by late 2021 they are able to demonstrate the ability to detect multiple STIs in parallel within 30 minutes. Also allowing them to begin user experience studies to ensure the kit is user friendly and results are readable.

2022 – As the startup is aiming for over the counter status, the bar is high and they have to navigate the regulatory pathway. Under the EU IVDR (In vitro Diagnostic Medical Device under Regulation) the test for sexually transmitted agents are usually Class C or Class D for HIV. This means that significant clinical evidence is required.

2024 – The company secures $6 M in seed funding to accelerate final development and regulatory submission [13]. The funding is earmarked for scaling up manufacturing of the disposable kits, obtaining the CE marking for Europe and conduct market validation studies.

2025 – Testmate is also pursuing UKCA marking to enter the UK market. Post launch the strategy will involve retail distribution and partnering with sexual health clinics and public health programs.

Scanadu / Inui Health (A cautionary Tale from the U.S.)

Not all attempts at home urine diagnostics have succeeded and it’s important to study how and why that happens. Inui Health formerly known as Scanadu is a Silicon Valley startup whose ambitions collided with regulatory reality. Founded in 2011 they set out to build a medical tricorder (tricorder is a fictional, handheld sensor and computing device from the Star Trek Universe, used for environmental scans, data recording and analysis). The company looked at 3 devices Scanadu Scout is a lightweight device that is touched to a patient’s temple and is touted as being able to return key vital sign results in less that 10 seconds. ScanFlo is a urinalysis test for conditions like diabetes, kidney failure, urinary tract infections and more. ScanaFlu was intended to be used when a patient exhibits flu like symptoms and the saliva test checks for Strep A, Influenza A and B, adenovirus and RSV [14].

Timeline

2011- Scanadu raises $2M from a network of global angel investors with the idea to check your body as often as your email [15].

2013 – Scanadu raises a further $1.6 m from 8,800 backers in a crowdfunding campaign, selling beta devices directly to consumers worldwide without regulatory approval. This approach was essentially a direct to consumer clinical trial, backers for the device on the condition they share data for FDA approval efforts. Scanadu generated massive hype and was often cited as a top health tech startup.

2016 – By late 2016 the FDA made it clear that the investigational device cannot be kept in use indefinitely without approval. Scanadu had missed timelines to submit its device for clearance. Facing regulatory pressure in December 2016 they shut down support for its devices to comply with regulations, rendering the Scanadu Scout effectively non-functional for users.

2017 – In an attempt to pivot Scanadu pivoted and rebranded as Inui Health and focused solely on the urine test platform.

2018 – Inui Health achieved an FDA 510(k) clearance for its smartphone based urine dipstick. However, by the time of clearance, Inui was low on funds and momentum. 2020 – In June 2020 it was acquired by Healthy.io for $9 m allowing Healthy.io to enter the U.S. markets on the back of Inui’s FDA clearance and IP.

Conclusions

Develop → Test → Approval → Sell.

There’s a lot to learn from the timelines of these companies. Some followed this traditional pathway carefully, while others rushed straight to market, often to their detriment. Even those who took the appropriate route, like Healthy.io and TestCard, faced financial strain due to the unpredictable waiting periods associated with regulatory approval. Multiple funding rounds are essential to survive these gaps and to finance ongoing validation, quality management, and regulatory submissions.

Achieving FDA clearance or CE/UKCA certification can be a major hurdle. New regulations such as the IVDR have raised the bar on evidence and quality systems, often requiring additional performance studies, updated technical documentation, and significant investment. The result is more robust devices, but also longer and costlier development cycles.

For companies like TestCard and Healthy.io, aligning early with UK healthcare needs was crucial. Close collaboration with the NHS not only built trust but also created opportunities for reimbursement and large scale pilots. Successful NHS partnerships often feed into programs like NHS England’s MedTech Funding Mandate or the Accelerated Access Collaborative (AAC), which provide validation and open doors to inclusion in national screening pathways. Early engagement with these frameworks can turn regulatory compliance into commercial advantage.

For more novel ventures such as The Blue Box, the challenges are deeper. With no established biomarker panel for breast cancer in urine and an AI based detection method, regulators will scrutinize both false negatives (missed cancers) and false positives (unnecessary anxiety). The company must run robust multi-centre clinical performance studies comparing results to mammograms or other gold-standard diagnostics. Beyond biological validation, The Blue Box must also prove the repeatability, reliability, and transparency of its AI algorithm ensuring ongoing monitoring and bias control. With only about $1.9 million in funding, regulatory clearance will likely require additional partnerships or investment. A smart strategy is to first position the product as a point-of-care clinical tool (potentially Class B) before moving toward unsupervised home use, reducing regulatory risk while gathering data.

Lastly, the success of companies like Healthy.io also demonstrates that strategic acquisitions can fast-track regulatory progress. Buying firms that already hold FDA or CE approvals as Healthy.io did with Inui Health can provide immediate access to validated IP, regulatory frameworks, and market entry pathways.

Overall, the common thread is clear. Success in this field demands a patient, evidence-driven approach. Regulatory readiness, clinical credibility, and strategic alignment with healthcare systems matter just as much as innovation. Those who integrate these elements from day one are the ones most likely to reach patients and stay there.

References

IDVR - https://euivdr.com/

MHRA - https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

[1] https://www.technologyreview.com/2019/04/24/135980/a-medical-app-uses-your-smartphones-camera-to-carry-out-lab-tests-at-home/

[2] https://www.gov.uk/government/news/smartphone-technology-in-bid-to-revolutionise-early-detection-of-kidney-disease#:~:text=In%20a%20project%20at%20Sussex,abnormal%20or%20highly%20abnormal%20results

[3] https://www.nice.org.uk/advice/mib221/chapter/The-technology#:~:text=hypertension,30

[4] https://www.jpost.com/jpost-tech/israeli-company-healthyio-buys-largest-american-competitor-inui-health-632999

[5] https://www.prnewswire.com/news-releases/urine-test-medtech-startup-closes-1-7m-funding-300717735.html#:~:text=Urine,financing%20led%20by%20Neo%20Ventures

[6] https://www.digitalhealth.net/2020/11/former-pitchfest-winner-testcard-secures-4-5m-funding-for-expansion/#:~:text=TestCard%2C%20which%20won%20Pitchfest%20in,into%20a%20clinical%20grade%20scanner

[7] finsmes.com/2022/04/testcard-raises-usd10m-in-funding.html#:~:text=In%202021%2C%20TestCard%20secured%20extensive,Rowlands%20and%20Lloyds%20Online%20Doctor

[8] thema-med.comblog.johner-institute.com).

[9] https://www.brokenhousecompany.it/blog/ilsanitario/2024/09/23/10-european-startups-that-turn-urine-into-opportunity/#google_vignette

[10] https://www.jamesdysonaward.org/en-US/2020/project/the-blue-box-1#:~:text=A%20household%20owning%20The%20Blue,a%20change%20in%20the%20way

[11] https://www.testmatehealth.com/

[12] https://ggba.swiss/en/testmate-health-raises-usd-6-million-to-combat-stis-with-innovative-home-testing-kits/#:~:text=The%20World%20Health%20Organization%20reports,term%20complications

[13] https://clpmag.com/disease-states/infectious-diseases/std/testmate-health-raises-6m-for-at-home-sti-test/#:~:text=Summary%3A%20Testmate%20Health%20secured%20%246,initially%20targeting%20chlamydia%20and%20gonorrhea

[14]https://en.wikipedia.org/wiki/Scanadu#:~:text=Scout%20is%20a%20lightweight%20device,13

[15] https://techcrunch.com/2011/11/08/scanadu-raises-2m-check-your-body-as-often-as-your-email/