PARSIPPANY, N.J., July 6,
2015 /PRNewswire/ -- PDI, Inc. (NASDAQ: PDII)
subsidiary Interpace Diagnostics announced today that effective
June 2015, ThyGenX™,i the
company's genetic mutation panel, has been approved by Aetna for
assessing fine needle aspiration (FNA) samples from indeterminate
thyroid nodules. Aetna's coverage decision now means that ThyGenX
is considered medically necessary. Aetna covers 46 million
lives and its positive coverage decision brings the total number of
lives covered for ThyGenX to more than 100 million.
Approximately 15-30% of the 525,000 thyroid FNA's performed on
an annual basis are indeterminate based on standard cytological
evaluation, and thus are candidates for ThyGenX. ThyGenX has
been validated in a prospective, clinical study involving over 600
patients and has a specificity rate of 89%.ii
Guidelines from the National Comprehensive Cancer Network (NCCN)
indicate that molecular diagnostic approaches may be useful in the
evaluation of thyroid FNA samples that are indeterminate to assist
in patient management, including identifying patients who are
appropriate candidates for surgery and those for whom surveillance
is appropriate.
According to Nancy Lurker, PDI's CEO, "Aetna's decision results
in the first major commercial coverage for ThyGenX and it continues
to affirm the value that ThyGenX offers to patients with
indeterminate cytology for thyroid FNAs. We are pleased that
Aetna's members now have access to ThyGenX, a test already
validated through peer-reviewed publications and that can help
reduce unnecessary thyroid surgeries."
About PDI, Inc.
PDI is a leading healthcare commercialization company providing
go-to-market strategy and execution to established and emerging
pharmaceutical, biotechnology, diagnostics and healthcare companies
in the United States through its Commercial Services
business, and developing and commercializing molecular diagnostic
tests through its Interpace Diagnostics business. PDI's Commercial
Services is focused on providing outsourced pharmaceutical,
biotechnology, medical device and diagnostic sales teams to its
corporate customers. PDI's Interpace Diagnostics is focused on
developing and commercializing molecular diagnostic tests,
leveraging the latest technology and personalized medicine for
better patient diagnosis and management. For more information about
us, please visit www.pdi-inc.com.
About ThyGenX™
Interpace Diagnostics' ThyGenX™ Thyroid Oncogene Panel molecular
diagnostic test is used to improve surgical decision-making for
patients with thyroid nodules when standard cytopathology does not
provide a clear diagnosis of thyroid cancer. ThyGenX assists
physicians in distinguishing between benign and malignant
indeterminate thyroid nodules by utilizing state-of-the-art
next-generation sequencing (NGS) to identify more than 100 genetic
alterations associated with papillary and follicular thyroid
carcinomas, the two most common forms of thyroid malignancies. The
ThyGenX panel design is based on the miRInform®
test, whose high predictive value has been validated in a recent
prospective clinical study involving over 600 patients. Interpace
Diagnostics acquired the miRInform test from Asuragen in
2014, and has now enhanced it by upgrading to a NGS platform which
provides greater genomic insights and increased panel
content.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, Section
21E of the Securities Exchange Act of 1934 and the Private
Securities Litigation Reform Act of 1995, relating to our future
financial and operating performance. PDI has attempted to identify
forward looking statements by terminology including "believes,"
"estimates," "anticipates," "expects," "plans," "projects,"
"intends," "potential," "may," "could," "might," "will," "should,"
"approximately" or other words that convey uncertainty of future
events or outcomes to identify these forward-looking statements.
These statements are based on current expectations,
assumptions and uncertainties involving judgments about, among
other things, future economic, competitive and market conditions
and future business decisions, all of which are difficult or
impossible to predict accurately and many of which are beyond PDI's
control. These statements also involve known and unknown risks,
uncertainties and other factors that may cause PDI's actual results
to be materially different from those expressed or implied by any
forward-looking statement. Known and unknown risks, uncertainties
and other factors include, but are not limited to, the market's
acceptance of our molecular diagnostic tests; projections of future
revenues, growth, gross profit and anticipated internal rate of
return on investments; the loss, early termination or significant
reduction of any of our existing service contracts; the failure to
meet performance goals in PDI's incentive-based arrangements with
customers; the inability to secure additional business; or our
inability to develop more predictable, higher margin business
through sales of our molecular diagnostic tests, in-licensing or
other means. Additionally, all forward-looking statements are
subject to the risk factors detailed from time to time in PDI's
periodic filings with the Securities and Exchange
Commission (SEC), including without limitation, the Annual
Report on Form 10-K filed with the SEC on March 5,
2015 and in PDI's Form 10-Q filed with
the SEC on May 12, 2015. Because of these and other
risks, uncertainties and assumptions, undue reliance should not be
placed on these forward-looking statements. In addition, these
statements speak only as of the date of this press release and,
except as may be required by law, PDI undertakes no obligation to
revise or update publicly any forward-looking statements for any
reason.
Corporate Media:
Corinne de Palma
CD Public Relations
(212) 399-0887
Corinne@CDPublicrelations.net
Trade Media:
Caren Begun
Green Room Communications
(856) 424-2023
caren@greenroompr.com
Investor Relations:
Chris Dailey/Michael Polyviou
EVC Group, Inc.
(646) 445-4800
cdailey@evcgroup.com
i ThyGenX is adapted and rebranded from
Asuragen's miRInform®
ii Labourier, Emmanuel et al. The Journal
of Clinical Endocrinology & Metabolism (2015):
jc-2015.http://press.endocrine.org/doi/abs/10.1210/jc.2015-1158.
Accessed July 1, 2015.
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SOURCE PDI, Inc.