Post-Approval Study of MelaFind

The primary objective of this study to test the hypothesis that, among eligible and
evaluable lesions with central histological reference standard status melanoma or high-grade
lesion, the relative sensitivity ρ comparing enrolling dermatologists after MelaFind use
with enrolling dermatologists if MelaFind were not available is greater than 110%. This
represents a clinically meaningful increase in sensitivity.

The secondary objectives of this study are to evaluate real-world use and safety and
effectiveness of MelaFind in a clinical setting.

Inclusion Criteria:

- The lesion is pigmented (i.e., melanin, keratin, blood)

- Clinical management of the lesion by the examining dermatologist is either biopsy of
the lesion in toto, or 3-month follow-up of the lesion

- The diameter of the pigmented area is between 2 and 22 millimeters

- The lesion is accessible to the MelaFind hand-held imaging device

- The patient, or a legally authorized representative, has consented to participate in
the study and has signed the Informed Consent Form

Exclusion Criteria:

- The patient has a known allergy to isopropyl alcohol

- The lesion has been previously biopsied, excised, or traumatized

- The skin is not intact (e.g., open sores, ulcers, bleeding)

- The lesion is within 1 cm of the eye

- The lesion is on mucosal surfaces (e.g., lips, genitals)

- The lesion is on palmar hands

- The lesion is on plantar feet

- The lesion is on or under nails

- The lesion is located on or in an area of visible scarring

- The lesion contains foreign matter (e.g., tattoo, splinter, marker)