PDI, Inc. Subsidiary Interpace Diagnostics Enters Molecular Diagnostics Market
with Thyroid and Pancreatic Cancer Test Portfolio Acquisition
Transaction Marks First Step Toward Creation of a Molecular Diagnostics
Subsidiary to Aid in Patient Diagnosis and Management
PARSIPPANY, N.J., Aug. 13, 2014
PARSIPPANY, N.J., Aug. 13, 2014 /PRNewswire/ --PDI, Inc. (Nasdaq: PDII), a
leading healthcare commercialization company, today announced that its
Interpace Diagnostics subsidiary has entered the expanding cancer molecular
diagnostics market with the acquisition of the miRInform^® Thyroid and
Pancreas cancer test assets from privately held Asuragen, Inc. This
acquisition marks the execution of PDI's strategy to create a commercially
driven molecular diagnostics business and a commitment to developing new
solutions for the thyroid and pancreatic cancer testing markets.
PDI, INC. subsidiary, Interpace Diagnostics, has entered the molecular
diagnostics market with a Thyroid and Pancreatic Cancer Test Portfolio
MiRInform Thyroid is a diagnostic assay comprised of 17 markers recommended by
the American Thyroid Association to detect genetic alterations that are
associated with thyroid cancer. MiRInform Thyroid is a clinically useful
prognosticator of thyroid cancer, which has demonstrated that the presence of
these oncogenic mutations is highly correlated with malignancy with a
post-test probability of thyroid cancer of 86 percent.^^[i] MiRInform Thyroid
is currently on the market and had approximately $2 million of revenue over
the past 12 months.
MiRInform Pancreas is a market-ready microRNA test expected to launch in the
first half of 2015. This product has demonstrated significant clinical utility
in detecting cancer in solid pancreatic tumors in a prospective clinical
This transaction includes the miRInform Thyroid and Pancreas tests,
intellectual property related to these and other tests in development for
thyroid cancer, and an extensive 5,000 plus tissue sample biobank to support
life cycle management efforts. Terms of the transaction include $8 million in
upfront cash, future commercial milestone-based payments and royalties.
"Today's portfolio acquisition is a pivotal step in PDI's strategy to leverage
our extensive healthcare go-to-market experience and infrastructure in the
higher margin, high-growth market of molecular diagnostics," said Nancy
Lurker, CEO, PDI, Inc. "It also complements our ongoing efforts in thyroid
cancer, where a prospective clinical validation study is underway on a
previously disclosed test that PDI has rights to in-license. Combined with the
acquisition of a much needed, innovative diagnostic in pancreatic cancer – a
devastating disease with limited molecular testing options – these tests set
Interpace Diagnostics on a path toward establishing a commercial presence in
Twenty to thirty percent of thyroid biopsy samples obtained through fine
needle aspiration (FNA) are considered indeterminate following cytological
analysis.^^[ii] MiRInform Thyroid is used by pathologists and endocrinologists
to improve preoperative diagnostic accuracy and aid in the characterization of
malignancy for malignant and indeterminate biopsied samples through the
analysis of 17 validated genetic alterations.
MiRInform Pancreas is expected to aid physicians in differentiating between
the benign condition of chronic pancreatitis and pancreatic cancer in solid
masses. Pancreatic cancer determination is often difficult with a significant
number of indeterminate diagnoses and up to a 30 percent false negative rate
for FNA biopsies.
About miRInform Thyroid
oMore than 525,000 FNAs are performed annually in the U.S. for suspected
thyroid cancer^^[iii], one of the fastest-growing cancers in the U.S.
oThe markers included in the miRInform Thyroid assay are in the American
Thyroid Association guidelines with a 'C' recommendation, meaning that it
is based on expert opinion.
oMiRInform Thyroid's high positive predictive value for diagnosing cancer
is clinically meaningful; as the presence of any oncogenic mutation in
patient samples was strongly associated with malignancy and the post-test
probability of thyroid cancer was 86 percent.
About miRInform Pancreas
oMore than 49,000 expected new pancreatic cancer diagnoses are expected in
2014 in the U.S.^^[iv]
oMiRInform Pancreas is expected to aid in the preoperative diagnosis of
pancreatic ductal adenocarcinoma by measuring expression levels of five
micro-RNAs in pancreatic masses.
oThe results of a prospective clinical validation study for this product
have been submitted for publication in a peer-reviewed journal and will be
available in 2H 2014.
"To better focus on our rapidly growing molecular diagnostic products and
translational diagnostic services businesses, Asuragen decided to divest the
miRInform assets," said Matt McManus, President and CEO of Asuragen. "PDI will
provide commercial leverage for capturing the value of our miRNA technology as
it applies to thyroid and pancreatic cancer. We look forward to working with
them through this transition as they seek to meet the important diagnostic
needs in these disease areas."
About PDI, Inc.
PDI is a leading healthcare commercialization company providing superior
go-to-market strategy and execution to established and emerging healthcare
companies through its three core business units. PDI's Interpace Diagnostics
subsidiary is working to develop and commercialize molecular diagnostic tests
leveraging the latest technology and personalized medicine for better patient
diagnosis and management. The company's Contract Sales business unit (CSO) is
a leading provider of outsourced pharmaceutical, medical device and
diagnostics sales teams. Its Group DCA division is a pioneer in insight-driven
digital communication services and integrated multichannel message delivery.
For more information about PDI, Inc. or Interpace Diagnostics, please visit
http://www.pdi-inc.com and www.interpacediagnostics.com.
This press release contains forward-looking statements regarding future events
and financial performance. These statements are based on current expectations
and assumptions 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. For example, with respect to statements regarding projections of
future revenues, growth and profitability, estimated gross profit and
anticipated internal rate of return on investments actual results may differ
materially from those set forth in this release based on 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 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, including without limitation, PDI's
previously filed Annual Report on Form 10-K for the year ended December 31,
2013 and current reports on Forms 10-Q and Forms 8-K. 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.
^^[i] Beaudenon-Huibregtse S, et al. Thyroid. [published online ahead of
print June 19, 2014]
^^[ii] Cooper, D. et al, Thyroid, Volume 16, Number 2, 2006: 109-141
^^[iii] Sosa JA, Hanna J, Lanman RB, Robinson KA, Ladenson PW. Increases in
thyroid nodule fine needle aspirations, surgeries and diagnoses of thyroid
cancer in the United States. American Association of Endocrine Surgeons 34th
Annual Meeting, Apr 14-16, 2013. Chicago, Ill. (oral abstract)
PDI is a leading health care commercialization company providing superior
insight-driven, integrated multi-channel message delivery to established and
emerging health care companies. The company is dedicated to enhancing
engagement with health care practitioners and optimizing commercial
investments for its clients by providing strategic flexibility, full product
commercialization services, innovative multi-channel promotional solutions,
and sales and marketing expertise.
Photo - http://photos.prnewswire.com/prnh/20140813/135989
Logo - http://photos.prnewswire.com/prnh/20140114/NY45872LOGO
SOURCE PDI, Inc.
Contact: Media: Caren Begun, Green Room Communications, (856) 424-2023,
Caren@GreenRoomPR.com; Investors: Asher S. Dewhurst, Westwicke Partners, LLC,
(443) 213-0503, Asher.Dewhurst@westwicke.com
Press spacebar to pause and continue. Press esc to stop.