HTG will serve as an exclusive commercialization partner for the recently identified assays, which may be useful for diagnostic and prognostic applications along the melanoma continuum. HTG has developed research assays and analyzed more than 400 annotated cases of melanoma from benign nevus to metastatic disease, resulting in several promising signatures. HTG is planning to license the signatures to primary reference laboratories or submissions to the U.S. Food and Drug Administration (FDA) in order to receive appropriate product clearances or approvals.

 

"This partnership will be the embodiment of the clinical application of molecular gene expression to which HTG Molecular Diagnostics dedicates our resources in our mission to improve patient care and ultimately help save lives," says HTG CEO T.J. Johnson. Johnson explains that the collaboration between HTG and JWCI began in 2010.

 

"The focus has always been on the melanoma continuum, with the goal of identifying genomic signatures to assist in diagnosis, prognosis and therapy decisions," he says. "HTG's unique advantages in working with archival paraffin-embedded tissues enabled these novel discoveries and this agreement is an exciting and critical next step in the process of applying translational molecular oncology to the detection and treatment of melanoma," says Dave Hoon, JWCI's scientific intelligence chief.  

 

Hoon says HTG proved to be an attractive fit for this partnership because the company has vast experience developing non-PCR-based molecular assays. 

 

"The program can utilize archival paraffin embedded tissues over 18 years where mRNA fragmentation or limited levels can be detected using a quantitative assay," he says. "JWCI has an established history in treatment of melanoma and development of innovative treatment regimens and molecular-based assays."  

 

He adds that the prospects are very good for the HTG melanoma signature assays.

 

"The objective is to correctly diagnose melanoma at early stages for appropriate treatment, and identify potential to metastasis disease outcome," he says. "If successful, this diagnostic assay will reduce treatment cost through more effective diagnosis of melanoma."    

 

The most impactful approach to reducing melanoma-related deaths is early detection and treatment. In the United States, the overall rate of melanoma diagnosis is increasing faster than any other cancer, with recent estimates for the lifetime risk of developing invasive melanoma at 1 in 49. The American Cancer Society estimates that nearly 10,000 people in the United States will die from melanoma in 2012.  

 

Johnson notes that the discoveries of the Human Genome Project are beginning to transform much of cancer care, especially diagnostics testing.  

 

"Based on the expression of specific genes, we are now able to determine the source of a patient's cancer, define their prognosis or predict their response to a specific treatment: real personalized medicine in action. HTG Molecular Diagnostics' qNPA-based technologies can do this with the smallest amount of samples and minimally invasive tests," he says.  

 

Johnson adds that the partners also hope to license the signatures to primary reference laboratories or submit to the FDA for appropriate product clearances or approvals. Moreover, the partners are able to reap the benefits of the clinical applications of gene expression, which provides a more accurate analysis of the tissue biopsy.  

 

"This leads to better diagnosis and prognosis biomarkers of cancer and disease outcome," Hoon explains. "Current approaches are too subjective, leading to inconclusive or incorrect diagnosis."