a new way to biopsy and analyze skin conditions

The term “biopsy” often evokes discomfort, conjuring images of painful procedures that remove substantial skin or tissue to screen for cancer or other serious skin conditions. In contrast, “microbiopsy,” or “skin microsampling,” represents a transformative approach in clinical dermatology—offering a minimally invasive method that significantly reduce discomfort.

Microbiopsy involves extracting a tiny, micro-sized skin specimen, often eliminating the need for numbing agents or stitches. This technique leaves a mark no larger than a pin-dot, which typically fades quickly, unlike the more noticeable marks left by traditional methods.

In some cases, the microbiopsy technique may be used as an alternative for more invasive or complex skin biopsy techniques that may not be necessary.

what brought us here: negative factors and drawbacks of 3 common skin biopsy methods

Why a biopsy and when is it needed?

Often, a dermatologist or other healthcare provider can diagnose certain skin conditions simply by looking at them. Yet many skin conditions, infections or abnormalities require a biopsy for further confirmation of the diagnosis. A skin biopsy procedure is therefore undertaken to remove the suspicious area of skin or tissue from the unfortunate patient who has to endure the uncomfortable procedure.

Skin Biopsy Types

The three common types of skin or tissue biopsy currently used to collect skin specimens for laboratory testing are moderately invasive, and typically require complex procedures performed by a specialized dermatologist or surgeon:

1. Shave biopsy: This involves removing the top layers of skin using a razor blade or scalpel. It's often used for conditions like non-melanoma skin cancer and actinic keratosis.
2. Punch biopsy: This procedure removes a deeper sample of skin using a circular instrument. It's commonly used to diagnose various types of skin cancer.
3. Excisional biopsy: This involves removing the entire lesion, including surrounding healthy tissue. It's typically used to confirm a cancer diagnosis and remove the tumor at the same time.

Any of these biopsy types can be associated with negative factors and drawbacks for both the patient and healthcare professional.

• The patient must endure pain or discomfort during and after the procedure. The procedure usually leaves scarring on the body, with stitches used to close the wound, and several days of wound healing. The stress caused by these factors is compounded if the biopsy is taken from a cosmetic or sensitive area, such as the face, or if multiple biopsies must be collected.
• The healthcare provider must undertake a complex, time-consuming procedure involving the use of sterilizing and numbing agents and tools to extract the specimen. Such a procedure must be performed in a clinical setting to avoid any risk of infection, and is dependent on certified or specially trained staff, making it very costly. 
• The specimen is typically stored in formalin to avoid degradation, which impedes any further molecular analysis. Lastly, when the suspicious specimen has been removed from the patient, the dermatologist usually does not have the opportunity to collect additional specimens or to monitor the evolution of the condition over time to enable information-rich decision making.

The microbiopsy technique was therefore developed to provide healthcare providers and, ultimately, patients an alternative pathway to detect and monitor specific molecular markers of skin conditions without the negative factors associated with the existing types of biopsy procedures.

microbiopsy: an advancement in skin biopsy technique

Skin microbiopsy technology was initially developed for use in molecular research to detect and monitor targeted biomarkers of skin cancers (e.g., melanoma and basal cell carcinoma) within and outside lesions. It also was developed to detect biomarkers of infectious skin diseases, such as viral warts or those from parasites.

The minimally invasive microbiopsy approach has the potential to also help clinicians in determining a person’s risk factors for developing skin cancers or other skin conditions, such as psoriasis or rosacea. An early identification of risk can facilitate prevention and early intervention at lower cost and reduced burden on the patient. Lastly, the approach enables any healthcare provider to collect a skin microbiopsy specimen from a patient without specialized training or certification.

areas where microbiopsy may be applied:

Dermatology

Research of investigational drugs or devices for treatment of skin conditions (cutaneous T-cell lymphoma, atopic dermatitis, sarcoidosis, acne, hidradenitis, wound healing applications and monitoring of photodamage) 

There is increased demand in dermatology research to investigate personalized skin therapies and to develop tools that can facilitate topical skin monitoring of inflammatory diseases, infectious diseases, and others. In the dermatology research field there also is a shift away from histopathology assessment toward targeted molecular diagnosis.

This requires additional skin tissue specimens to be collected to enable information-rich decision making. The need for more research specimens creates a challenge – study volunteers (patients) are more likely to resist frequent sampling with invasive methods like shave or punch biopsy.

Microbiopsy can potentially provide a less invasive topical sampling method that enables the collection of additional specimens over time without the discomfort of more invasive methods.

Pharmaceutical Industry

Skin creams and other topical products from the pre-clinical to clinical phases, up to companion diagnostics. 

The development of medicinal creams for skin conditions requires the pharmaceutical industry to conduct clinical trials to bring a safe and effective product to the market. The challenge is to make truly adaptive clinical trials by acquiring high-quality datasets swiftly and economically. Principal investigators need to be able to intervene in instances of non-compliance while enabling the collection of more and alternate data points. This is currently not possible with traditional skin sampling.

A skin microbiopsy workflow could help simplify the volunteer recruitment process for clinical trials by eliminating the clinical and ethical concerns related to traditional biopsy. Additionally, skin microbiopsy could improve the patient experience, thereby improving compliance and retention in the clinical study. Microbiopsy could also improve the acquisition of additional samples and topical data points, thus reducing overall costs and shortening the trial and time to market.

Cosmetology & Wellness

For personalizing skin treatments or monitoring aging skin, as well as testing new ingredients for developing skin creams

There are many skin concerns beyond skin cancers or diseases that need to be assessed, including skin type, spots, dark circles, redness, etc. These skin concerns usually involve cosmetically sensitive areas of the body (i.e., face, neck, hands), which obliges clinicians to use non-invasive and subjective methods for assessment. Yet, providing precise assessment of skin conditions without using invasive methods is a challenge.

A skin microsample allows professionals in cosmetology and wellness settings to offer more personalized and in-depth skin consultations, without the need for large, expensive equipment or specialized training. A skin consultant can potentially use the microbiopsy tool to collect a quick skin microsample and perform a skin analysis to guide individualized skincare and product recommendations. Personalized skincare regimens are easy to build once the skin tissue has been analyzed to generate high-quality data.

Public Health and Surveillance Institutions

For understanding the surveillance and control of diseases for many vector-born or tropical skin diseases, as well as forensic applications

Skin disease control and surveillance are the mission of epidemiology organizations and other governmental public health institutes. Such groups usually conduct their research in remote settings – in low- and middle-income countries where such diseases may be more prevalent.

For example, Cutaneous Leishmaniasis (CL) is one such skin disease that is prevalent in Central and South America, the Mediterranean Basin, the Middle East, and Central Asia, with approximately 1 million new cases per year. CL is caused by parasites which are transmitted by the bite of infected sandflies. It is challenging for health institutes to screen for CL to improve disease control and surveillance using standard skin sampling methodologies.

A skin microsampling method could improve the standard of care for CL in such countries by providing a means for early diagnosis, parasite species identification and, ultimately, to provide adequate treatment prior to scar formation and further stigmatization of individuals.

Veterinary and Animal Testing

For animal testing of inflammatory and infectious diseases, as well as skin cancer in pets or livestock.

As with practitioners in the dermatology sector, veterinarians seek minimally invasive methods for diagnosing, monitoring and treating animal skin diseases. Also, in the context of the ethical use of animals for product testing and epidemiological studies, it is challenging for research scientists to rely on invasive skin sampling methods that may inflict pain or harm to study animals.

A skin microbiopsy would provide veterinarians and research scientists a more ethical way to frequently monitor the health of animals with advanced analytical techniques from a microbiopsy specimen. Microbiopsy could also enable repeated specimen collection for more efficient animal modelling.

microbiopsy: an alternative to punch and scalpel skin biopsy 

The innovation of a microsampling tool like Harpera™ can support a variety of research fields by providing a punch biopsy tool that offers a less invasive but accurate, skin sampling technique. This technology may enhance the patient and practitioner experience and potentially broaden the scope of  research applications by reducing the invasiveness of traditional skin biopsies.
 
Harpera™ offers a modern and comfortable sampling option for healthcare providers, cosmetologists, and professionals in clinical or non-traditional environments. The Harpera microbiopsy collection approach is designed to work with existing methodologies and is perfectly suited to modern molecular diagnosis.

Related Reading:

Jain, M.,et al. (2022). "Minimally invasive microbiopsy for genetic profiling of melanocyticlesions: A case series." J Am Acad Dermatol 87(4): 903-904.

Preis, S., et al. (2022). "Munich atopy prediction study (MAPS): protocol for a prospective birth cohort addressing clinical and molecular risk factors for a topic dermatitis in early childhood." BMJ Open12 (9):e059256.

Liverpool School of Tropical Medicine (April 2023). “Using BCG Vaccine to Understand Tuberculosis Infection”, NCT05820594 (ClinicalTrials.gov)

Van Henten, S., et al. (2024)."Evaluation of Less Invasive Sampling Tools for the Diagnosis of Cutaneous Leishmaniasis." Open Forum Infect Dis 11(4): ofae113.

Image Credits: Trajan, Neoteryx