Mitra Bio secures EU grant to expand non-invasive skin cancer testing

Mitra Bio has received €2.5 million (US$2.88 million) in funding from the European Innovation Council (EIC) to support clinical trials of its epigenetics-based skin test for early melanoma detection.

The London-based biotechnology company will conduct a multi-site trial at four hospitals in the UK and the EU to validate its non-invasive tape-strip DNA methylation assay.

Mitra Bio’s proprietary epigenetics platform was originally used by skin care and medical device partners to assess markers such as inflammation, biological skin age, and cellular regulation. The technology is expanding to ease pressure on dermatology services by providing faster, objective results that could reduce the need for biopsies.

According to the company, over 700,000 annual skin cancer referrals in the UK alone are ultimately diagnosed as benign. Mitra Bio hopes its test can streamline triage, cut hospital costs, and improve patient experience.

Personal Care Insights speaks with Mitra Bio’s co-founder and CEO, Dr. Shakiba Kaveh, and the company’s co-founder and CSO, Dr. Cristiana Banila, about how the grant will support large-scale validation of their biomarkers.

“As few as 6% of suspected melanoma biopsies actually turn out to be cancerous, so in a clinical trial, you end up with much more non-cancerous samples than cancerous ones,” Banila says.

Kaveh explains that the vision is for patients to one day access melanoma screenings through pharmacies with results delivered in days rather than weeks, helping relieve bottlenecks in current specialist referral pathways.

The grant was awarded through the EIC Accelerator, touted as one of Europe’s most selective funding mechanisms. Mitra Bio was among 40 start-ups selected from nearly 950 applicants across the biotechnology, AI, and space sectors.

Non-invasive skin cancer detection

The grant-funded trial responds to a need in European health care systems, where a surge in skin cancer referrals is straining dermatology services, according to the company.

Mitro Bio says, in the UK, 60% of over one million annual dermatology referrals are flagged as suspected skin cancer, yet nearly all are benign. This diagnostic overload results in long wait times, unnecessary procedures, and elevated health care costs.

Mitra Bio’s assay uses a skin-tape strip to collect epigenetic material, avoiding the need for surgical biopsy.

The €2.5 million EIC grant will support Mitra Bio’s clinical trials across UK and EU hospitals.“Traditionally, tape stripping yields tiny amounts of DNA, as little as a few nanograms. At Mitra Bio, we’ve developed a proprietary workflow that allows the extraction of epigenetic biomarkers, specifically DNA methylation, from very low DNA input,” Banila explains.

“Epigenetic changes on the DNA structure can turn genes on and off. With cancer development, certain beneficial genes, such as tumor suppression genes, may be turned off. In contrast, other detrimental elements, such as those behind uncontrolled cell growth and division, may be activated.”

She says these patterns are captured in the cells’ epigenetic profiles, allowing them to determine whether a sample is likely to be cancerous or not, delivering test results in a matter of days.

The tool could enable more efficient use of clinical resources by distinguishing between benign and malignant lesions early in the process.

Kaveh emphasizes the importance of patient-centered innovation. “Referral to a specialist can take weeks, followed by a biopsy that takes another few weeks to be processed and reported.” 

“We hope to reduce both the strain on our health care systems and the stress for patients.”

Building on early evidence

The upcoming trial builds on a 2023 pilot study with Guy’s and St Thomas’ National Health Service Foundation Trust. That study demonstrated the assay’s ability to identify unique DNA methylation markers associated with cancerous lesions in 217 participants with lesions suspected to be melanoma.

The results supported the platform’s potential to complement or even reduce the need for histopathology (the study of tissue changes caused by disease).

Banila explains the company has made technical advancements in DNA methylation analysis since the pilot study.

Over 60% of annual dermatology referrals in the UK are flagged as potential skin cancer, yet most prove to be benign.“Melanoma lesions and moles are often hyperkeratotic; they are thicker, drier, and contain more keratin — the protein that makes up our hair, nail, and outer skin. Historically, it has been difficult to sample and perform DNA methylation profiling on these lesions, because tape stripping can yield even less DNA material than usual.”

“Following our 2023 pilot study, we’ve been hard at work improving our lab protocol to be able to extract more DNA from this type of skin, to improve our accuracy and reduce the likelihood of an inconclusive result,” Banila says.

Looking back to go forward

As Mitra Bio extends into oncology applications, the move represents a shift from cosmetic and wellness applications to more high-stakes clinical diagnostics.

“Skin health and longevity are deeply interconnected,” Kaveh says. “At Mitra Bio, we have observed UV damage as the leading driver of skin aging — and the same culprit behind skin cancer. Aging and cancer are two sides of the same coin.”

She explains that, by studying the biology of skin aging, Mitro Bio has uncovered key factors that contribute to disease development and identified opportunities for earlier intervention, which helped nudge the tool into the medical sector.

Kaveh notes that “there will be many challenges ahead” in introducing this assay into routine clinical or pharmacy-based melanoma screening.

“But, it’s essential we address each one carefully to ensure that the benefits of Mitra Bio’s tests truly reach patients.”

She says navigating logistical challenges is key to optimizing the time to result. Furthermore, the company expects to face regulatory challenges to get the tests approved as medical devices in the UK and EU.

Finally, she foresees adoption challenges “to shift the thinking of dermatologists, general practitioners, and entire health care systems to go from treatment to prevention.”