Spanning the melanoma continuum

TUCSON, Ariz.—HTG Molecular Diagnostics is collaboratingwith the John Wayne Cancer Institute (JWCI) to market its melanoma signatureassays.

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

"This partnership will be the embodiment of the clinicalapplication of molecular gene expression to which HTG Molecular Diagnosticsdedicates our resources in our mission to improve patient care and ultimatelyhelp save lives," says HTG CEO T.J. Johnson.

Johnson explains that the collaboration between HTG and JWCIbegan in 2010.

"The focus has always been on the melanoma continuum, withthe goal of identifying genomic signatures to assist in diagnosis, prognosisand therapy decisions," he says.

"HTG's unique advantages in working with archivalparaffin-embedded tissues enabled these novel discoveries and this agreement isan exciting and critical next step in the process of applying translationalmolecular 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 thispartnership because the company has vast experience developing non-PCR-basedmolecular assays.

"The program can utilize archival paraffin embedded tissuesover 18 years where mRNA fragmentation or limited levels can be detected usinga quantitative assay," he says. "JWCI has an established history in treatmentof melanoma and development of innovative treatment regimens and molecular-basedassays."

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

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

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

Johnson notes that the discoveries of the Human GenomeProject are beginning to transform much of cancer care, especially diagnosticstesting.

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

Johnson adds that the partners also hope to license thesignatures to primary reference laboratories or submit to the FDA forappropriate product clearances or approvals. Moreover, the partners are able toreap the benefits of the clinical applications of gene expression, whichprovides a more accurate analysis of the tissue biopsy.

"This leads to better diagnosis and prognosis biomarkers ofcancer and disease outcome," Hoon explains. "Current approaches are toosubjective, leading to inconclusive or incorrect diagnosis."