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 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.

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 that registers 100% sensitivity and 88% specificity in detecting melanoma in suspicious pigmented lesions.

Development of a Multi-Gene Classifier Accurately Discriminates Melanoma from Atypical Nevi

Supervised analysis of GeneChip data
Training set: 37 melanomas and 37 atypical nevi

Testing set: 39 melanomas and 89 atypical nevi

Melanoma Detection Data

Heatmap
 Yellow   Melanoma sample (vertically)
 Blue   Non-melanoma sample (vertically)
 Red   Elevated gene expression
 Green   Unelevated gene expression lower than the mean



Based on data generated by a microarray, the diagram above (heatmap) offers a visual representation of how we are able to classify the melanomas versus the benign lesions.

On the Y-axis are the 19 genes in our melanoma biomarker panel. On the X-axis, are the 202 RNA samples taken from suspicious pigmented lesions on the skin. The sample group included: melanoma in situ, invasive melanoma, superficial spreading melanoma, lentigo maligna melanoma and atypical nevi.

The blue-labeled samples were deemed to be benign by two expert pathologists while the yellow-labeled samples were deemed to be melanoma. Even to the untrained eye, it is easy to see that the gene expression profile for melanoma is significantly different than for benign lesions. This discovery has laid the groundwork for the development of our detection test. In studies of dermatology patients, the technology has registered 100% sensitivity (never missing a melanoma) and 88% specificity (only 12% false positives vs. the doctor’s false positive rate of 95%) – results that are significantly better than any current detection technique or known product in development.

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 subjective 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.

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.

MelDTect™ Sample Report