The guidance therefore recommends further research studies undertaken in NHS settings to determine their clinical and cost effectiveness for deciding whether to biopsy and remove skin lesions in people with suspected melanomaⁱ, basal cell carcinomaⁱⁱ, or lentigo malignaⁱⁱⁱ, and for defining margins of skin lesions in people with lentigo maligna and basal cell carcinoma.

The guidance also does not recommend the use of the VivaScope imaging systems for helping to decide whether to biopsy and remove suspected invasive squamous cell carcinomas^iv, or for defining margins of skin lesions in people with melanoma or invasive squamous cell carcinomas.

The VivaScope 1500 and 3000 imaging systems are non-invasive, high resolution, reflectance laser confocal microscope systems that are designed to help assess potentially malignant skin lesions. They aim to provide a highly magnified image of skin cells that is reportedly comparable to microscopic examination of a skin specimen. The VivaScope imaging systems are designed to be used with dermoscopy to help diagnose potentially malignant skin lesions, to define tumour margins for excision or to monitor healing after treatment.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “The incidence of skin cancer, particularly malignant melanoma, has increased dramatically since the 1970s, as has the number of biopsies carried out to diagnose these cancers. The Committee heard from a patient expert that people can experience substantial anxiety about scarring as a result of skin biopsies, particularly on the face and neck. Non-invasive tests to help decide whether to biopsy could potentially lead to fewer biopsies being needed, as well as reducing the burden on pathology laboratories.

“Based on the available evidence the Committee concluded that the VivaScope imaging systems show promise. However, they felt there was too much uncertainty in the evidence for it to be confident that using the systems represents a cost-effective use of NHS resources. The guidance therefore recommends that further evidence is generated in NHS settings to demonstrate the impact of using the VivaScope 1500 and 3000 imaging systems in the clinical workflow of melanoma and basal cell carcinoma assessment in secondary care in England.”

ENDS

For more information call the NICE press office on 0300 323 0142/ pressoffice@nice.org.uk or out of hours on 07775 583 813.

Notes to Editors

References and explanation of terms

1. Melanomas develop from cells (melanocytes) lying in the deeper layers of the epidermis. Melanomas may be classified into a number of broad types (superficial spreading melanomas, nodular melanomas, lentigo maligna melanomas, acral lentiginous melanomas) depending on their growth characteristics, appearance and location on the body.
2. The most common type of skin cancer, basal cell carcinomas are one of a group of non-melanoma skin cancers. Basal cell carcinomas develop in keratinocytes deep in the epidermis. Although rarely fatal, if basal cell carcinoma is not diagnosed early enough, or is not properly treated, it can result in tumours that destroy important anatomical structures, such as the nose, eye, ear and lips. As such, it can be more challenging to treat and can result in the tumour becoming inoperable.
3. One of the four clinical types of malignant melanoma and the slowest growing type. Lentigo maligna melanoma typically begins as a patch of mottled pigmentation that is dark brown, tan, or black on sun-exposed skin, such as on the face.
4. Squamous cell carcinoma is one of the two most common types of non-melanoma skin cancer (the other being basal cell carcinoma) and of the two is the more serious. It is the second most common skin cancer with 26,000 cases in the UK in 2011 and its incidence is increasing. While basal cell carcinoma develops in keratinocytes deep in the epidermis, squamous cell carcinoma develops from keratinocytes elsewhere in the skin.

About the diagnostics guidance on VivaScope 1500 and 3000 imaging systems

1. The NICE diagnostics guidance on the VivaScope 1500 and 3000 imaging systems for detecting skin cancer lesions is available on the NICE website at http://www.nice.org.uk/guidance/dg19

 About skin cancer

1. Skin cancer is commonly classified into two main types; melanoma skin cancer (MSC) and non-melanoma skin cancer (NMSC). Melanoma skin cancers develop from melanocytes, skin cells that produce the skin-darkening pigment, melanin, while non-melanoma skin cancers develop from the proliferation of the cells that produce the skin structural protein, keratin (keratinocytes). These two categories of cancer include more than 95% of all reported skin cancers.

Melanoma skin cancers

1. Though uncommon, melanoma incidence rates increased 7 fold between 1976 and 2009. In the UK, it is most common in people aged 50 years and over although a fifth of cases occur in young adults. The increase in incidence of melanoma may be caused by increased surveillance but it is estimated that over 80% of cases are linked to UV exposure related to recreational behavioural change involving sun exposure and the use of sunbeds (Cancer Research UK, 2014). The incidence of melanoma is lower in lower socio-economic groups.
2. Malignant melanoma can invade nearby tissue and potentially spread to other parts of the body. It is responsible for the majority of skin cancer deaths and in the UK in 2012 there were approximately 2,000 deaths from malignant melanoma. Survival has improved substantially in recent decades and the survival rate is among the highest of any cancer, largely as a result of increased awareness, earlier diagnosis and better treatments (Cancer Research UK, 2014).
3. Treatment is more likely to be successful when melanoma is detected in its early stages. In the UK, the majority of malignant melanomas are diagnosed at an early stage; 82% in men and 87% in women presented at stages 1 or 2 in 2010. In men, most melanomas present on the trunk (41%), head and neck (22%) or arms (19%). In women the most common sites for presentation are legs (39%), arms (24%) and trunk (20%).
4. Melanomas may be classified into a number of broad types (superficial spreading melanomas, nodular melanomas, lentigo maligna melanomas, acral lentiginous melanomas) depending on their growth characteristics, appearance and location on the body.

Non-melanoma Skin Cancer (NMSC)

1. Non-melanoma skin cancers are a group of very common cancers, estimated to account for around a third of all cancers detected in the UK. 102,628 cases of non-melanoma skin cancer were recorded in the UK in 2011. However, the true number of cases is thought to be higher because not all cancers are recorded by the cancer registries.
2. Non-melanoma skin cancers most commonly develop from epidermal cell, keratinocytes, which produce the skin strengthening protein keratin. The two most common types of non-melanoma skin cancer are Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC). Basal cell carcinoma develops in keratinocytes deep in the epidermis, while squamous cell carcinoma develops from keratinocytes elsewhere in the skin.
3. Of the two types of non-melanoma skin cancer, squamous cell carcinoma is the more serious. It is the second most common skin cancer with 26,000 cases in the UK in 2011 and its incidence is increasing.
4. Basal cell carcinoma is the most common type of skin cancer. About 75 out of every 100 cases of non-melanoma skin cancers diagnosed are this type – approximately 76,000 cases in 2011.
5. Basal cell carcinoma is rarely fatal. However, if basal cell carcinoma is not diagnosed early enough, or is not properly treated, it can result in tumours that destroy important anatomical structures, such as the nose, eye, ear and lips. As such, it can be more challenging to treat and can result in the tumour becoming inoperable.

 About the NICE Diagnostics Assessment Programme 

1. For further information about the NICE diagnostics assessment programme see Developing NICE diagnostic technologies guidance  
2. Topics to be considered by the Programme are routed through the related Medical Technologies Evaluation Programme. Further information about this can be found at Developing NICE medical technologies guidance