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Evidence to Improve Care

Pigmented Lesion Assay for Suspected Melanoma Lesions

Final Recommendation

  • Ontario Health, based on guidance from the Ontario Health Technology Advisory Committee, recommends against publicly funding pigmented lesion assay for people with suspected melanoma lesions

Read the final recommendation report

Early diagnosis of melanoma (a type of skin cancer) is very important because it can improve a person’s chances of surviving. Currently, primary care providers inspect suspicious moles visually to determine if biopsy and lab testing are needed to confirm a diagnosis of melanoma. They may also refer people to a dermatologist, a person who treats skin diseases, to consider the need for a biopsy to confirm a diagnosis.

A pigmented lesion assay is a test that involves applying an adhesive patch to the suspicious mole. The patch is then sent to a laboratory to determine if either of two genes is detected in the mole. The manufacturer recommends that if neither gene is detected, then the person likely does not need to have a biopsy taken from that mole.

This health technology assessment looked at how accurate and effective pigmented lesion assay is for people with suspected melanoma lesions. It also looked at the budget impact of publicly funding pigmented lesion assay. And finally, it looked at the experiences, preferences, and values of people who have had skin biopsy for melanoma.

Read the full health technology assessment report for more information.

Pigmented Lesion Assay for Suspected Melanoma Lesions: A Health Technology Assessment (PDF)
June 2021

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The Ministry of Health has accepted this recommendation.

The Ministry of Health has provided the following response: The Ministry has a standardized process in place to review health technology assessments and funding recommendations. This takes into consideration Ministry priorities, implementation options, the need for consultation with impacted stakeholders, and funding considerations.



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