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Spanning the
melanoma continuum
July 2012
EDIT CONNECT
SHARING OPTIONS:
TUCSON, Ariz.—HTG Molecular Diagnostics is collaborating
with the John
Wayne Cancer Institute (JWCI) to market its melanoma signature
assays.
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." Code: E071214 Back |
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