MelaFind – Skin Cancer Detection Device (Recalled)

melafind skin cancer diagnosis melanoma
MelaFind – An innovation in skin cancer detection, or expensive gadget?

Skin cancer detection could get a lot easier with the recent FDA approval of MelaFind, a device by Mela Sciences that can help detect early signs of melanoma. This is the most serious of skin cancers, often fatal, and not always noticed in time for treatment to be effective.

Mela Sciences’ device had been waiting for approval by the FDA since June 2009 and the company recently filed a petition to contest the delay when approval came in September 2011.

MelaFind had already been approved in Europe and it is hoped that the company’s innovative product will help identify patients early and help lower the fatalities associated with melanoma.

UPDATE: MELA Sciences has voluntarily recalled 65 MelaFind recall units as of May 20th, 2015, due to a lack of approval for the device’s user interface.

MelaFind – Advances in Skin Cancer Detection

MelaFind is a handheld, non-invasive device designed to detect cutaneous malignant melanoma early so as to improve patients’ chances for successful treatment. The scanner is loaded with diagnostic-imaging algorithms that can predict the malignancy of a pigmented melanocytic lesion but critics are worried that the medical device will encourage doctors to rely on the scanner rather than their own best judgement. In the US only dermatologists with training in the use of MelaFind will be approved to employ the scanner.

MelaFind vs. Dermatologists

A multicenter study assessing the competency of MelaFind compared the device to experienced dermatologists when diagnosing patients’ pigmented skin lesions. Nearly 1400 patients with more than 1600 lesions between them were evaluated during the study and MelaFind identified all but two melanomas making it 98.4% sensitive. The dermatologists’ average biopsy sensitivity was 78%. The device also performed favourably against clinicians when evaluating pigmented lesions (9.9% vs 3.7% specificity).

Disadvantages of MelaFind

One drawback of MelaFind is the device’s high level of false positives when assessing malignant melanomas. One study found that lesions identified as malignant melanomas by MelaFind turned out not to be melanomas in up to 15% of cases. Another drawback is the cost of the device, at around $7500 which could mean that few patients have access to the device, at least initially.

However, there have been suggestions that MelaFind could be of assistance in areas where experienced dermatologists are unavailable, despite the device being currently approved only for use by a select few dermatologists.

The worry with MelaFind, and one of the reasons for the FDA approval being substantially delayed, is that the device may come to overrule clinical judgement and risk ignoring pertinent factors such as family medical history, patient history, and the presence of dysplastic nevi (abnormal moles).

Reducing Melanoma Deaths

The hope is that the approval of MelaFind could help in detecting malignant melanoma early in order to make the success of skin cancer treatment more likely. More than 70,000 people are estimated to be diagnosed with malignant melanoma in the US alone this year and it is likely that around 10,000 deaths will be attributed to this, most deadly form, of skin cancer.

Once several concerns have been addressed it may be that MelaFind becomes a routine part of skin caner detection but issues of economy, regulated use by experience practitioners, and the ability of the device to assess less common melanoma subtypes remain problematic.

Amelanotic malignant melanoma, acral lentiginous MM, nevoid or spitzoid MM, and melanoma in patients with darker skin remain potential problems with the device that have yet to be rigorously assessed. The hope is though that earlier detection of skin cancer will be possible with the recent FDA approval of MelaFind for melanoma screening.

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