PDI, Inc. PDII
subsidiary, Interpace Diagnostics, announced today new data supporting the use
of combination platform testing with ThyraMIR™, the first and only microRNA
expression classifier, and ThyGenX™ Thyroid Oncogene Panel, a DNA and RNA
mutational analysis, to improve thyroid cancer diagnosis. The study, presented
at ENDO 2015: The 97^th Annual Meeting & Expo of the Endocrine Society held
March 5-8, 2015 in San Diego, CA, showed that benign or malignant nodules can
be identified with high sensitivity and specificity resulting in clinically
actionable negative predictive value (NPV) at 94% and positive predictive
value (PPV) at 74%. The effect of combining nucleic acid sequencing with a
gene classifier significantly improved the tests' ability to correctly
identify both benign and malignant nodules, potentially resulting in fewer
unnecessary surgeries.
In this histologically blinded, multicenter, cross-sectional cohort study,
data was summarized from 109 nodules with indeterminate cytology and surgical
outcomes of primary benign or malignant thyroid lesions established by local
pathology expertise from 12 representative endocrinology centers across the
United States. Following fine needle aspiration, combined use of mutation
testing and ThyraMIR had an overall sensitivity of 89% and specificity of 85%.
Importantly, researchers noted the improvements relative to current molecular
classification methods are applicable regardless of the local prevalence of
thyroid cancer.
"These promising results support the addition of microRNA testing to oncogene
mutational analysis. This combined gene expression and genotyping approach is
designed to more accurately diagnose and characterize thyroid nodules," said
Thomas J. Giordano, M.D., Ph.D., Department of Pathology, University of
Michigan, and a study author. "This can help clinicians to make the most
appropriate management recommendations for their patients and hopefully avoid
unnecessary surgeries on benign nodules."
Approximately 525,000 thyroid nodule fine needle aspiration (FNA) procedures
are performed each year in the United States. Prevalence of thyroid cancer in
the clinical setting is often not known and varies between institutions.
Indeterminate cytology diagnoses are common and represent approximately 15% to
30% of cases. National Comprehensive Cancer Network (NCCN) and American
Thyroid Association (ATA) guidelines currently recommend consideration of
molecular testing on these indeterminate cases to help inform treatment
decisions and to help avoid unnecessary surgery on benign nodules, which may
occur in 70% to 80% of the cases.
"We are excited about these compelling data and that the use of this first and
only microRNA gene expression classifier, combined with our thyroid oncogene
mutational panel, can potentially further advance the diagnosis and treatment
of thyroid lesions beyond currently available tests," said Nancy Lurker, CEO
of PDI, Inc.
While studies support the value of mutational analysis, evidence continues to
accumulate clearly showing that detection of ever-increasing numbers of
uncommon mutations does not by itself provide diagnostic clarity, but in fact
contributes to diminishing specificity for cancer detection.
Added Sydney Finkelstein, M.D., Chief Scientific Officer of Interpace
Diagnostics: "A combined approach, fundamental to our testing, offers the most
effective means to guide individual patient management and optimize healthcare
resources."
A link to the abstract can be found at:
https://endo.confex.com/endo/2015endo/webprogram/Paper18782.html.
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