MelDTect™ Melanoma Detection Test

Our first product candidate called MelDTect™ is for the non-invasive and genetic-based detection of melanoma. The test does not require a biopsy, so it is painless and it is based on genetics, so it is highly accurate.

The MelDTect™ test is expected to aid the physician in determining whether or not to perform a surgical biopsy on a suspicious mole. Today dermatologists on average, produce negatives 24 out of 25 times. In other words, 25 biopsies are needed to identify one melanoma. There have been few new tools to offer significant help to the physician and those that have been introduced generally are based on magnification and enhancing visual acuity. And once a tissue sample has been examined by a pathologist, there remains the potential for incorrect or inconclusive results because pathology readings are objective and like the skin exam, rely on visual cues.

Today with the advances in genomics, there is an opportunity to introduce a next-generation test. With our test, patients wouldn’t need to undergo a biopsy unnecessarily and would be confident that results generated by the MelDTect™ approach were based on subjective, genomic information. An added benefit is that because the technique is non-invasive, it can be performed by anyone in the physician’s office.

How Does a Dermatologist Use the MelDTect™ Test to Identify a Melanoma?
Dermatologists and their patients have provided extremely positive feedback on the adhesive-based skin cell sample collection device shown below (based on discussions with physician participants in our international melanoma sample collection study). 

EGIR Sampler™ device

EGIR® tape rolls on skin, collects genetic material, device capped and sent to lab

The testing process is simple and straightforward. MelDTect™ is based on our patented Epidermal Genetic Information Retrieval (EGIR®) technology. The non-invasive test works by rolling a 6cm piece of adhesive on a suspicious looking mole to harvest genetic matter in the form of RNA from the surface layer of the skin. Using our patented melanoma biomarker, the RNA is then analyzed to identify potentially fatal skin cancer.  Results based on RNA collected easily from the skin, are sent back to the physician in the form of a report showing the probability that the lesion is a melanoma.

More than 25 sites in the US, Europe, and Australia are currently or have been participating in a multi-center discovery study to create a sample set of pigmented skin lesions, which can then be used to identify the correlation between gene expression data and histopathology. This information was used to create a candidate multi-gene biomarker for the detection of melanoma. A 17-gene marker has been discovered with high sensitivity and specificity in detecting melanoma in suspicious pigmented lesions.