Interpace Diagnostics Announces Agreement with Blue Cross Blue Shield (BCBS) "Center for Clinical Effectiveness" to Support Enhanced Coverage

PARSIPPANY, N.J., Jan. 3, 2017 -- Interpace Diagnostics Corp. (NASDAQ: IDXG), a company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risks of cancer, announced today that the Company has entered in to an Agreement with the Blue Cross Blue Shield (BCBS) Association's Center for Clinical Effectiveness "Evidence Street", a program that, while not making coverage decisions, provides the Company with the opportunity to provide available evidence for its molecular Thyroid and Pancreas tests, to support further coverage determinations among Blue Cross Blue Shield and other health plans. Blue Cross Blue Shield's 36 independent plans and Companies account for approximately 106 million covered lives in the U.S. 

 

As part of the Agreement, Interpace will work with Evidence Street to develop the optimal ways for the Company to secure and preserve ongoing coverage for not only its currently marketed products but also for those tests in the pipeline being launched in the near future. All of Interpace's currently marketed products are covered regionally by Medicare and numerous commercial plans, including certain BCBS plans. 

While the BCBS plans apply numerous criteria in their evaluation of technologies, the two criteria most heavily weighted are clinical utility and patient outcomes.  The Company has conducted numerous studies for their products in both its Endocrine (Endo) franchise, i.e. ThyGenX® and ThyraMir®, and Gastrointestinal (GI) franchise including PancraGen® and BarreGen® for pancreatic and esophageal cancer respectively.  The data from these studies have been published in multiple peer-reviewed publications such as Journal of Clinical Endocrinology and Metabolism, American Journal of Gastroenterology, and Endoscopy.   These publications provide favorable conclusions regarding the clinical utility of the Company's molecular tests.  The ECRI Institute, another independent review organization, published a review of PancraGen in April 2016, in which it concluded "PancraGen is more predictive of real life patient management than current guidelines."

 

Jack E. Stover, President and CEO of Interpace Diagnostics stated, "We are excited about our evolving relationship with Blue Cross and Blue Shield's Evidence Street which, we believe, will help ensure that we continue to develop and provide the information and data necessary to support and secure broader based insurance coverage and reimbursement for all of our products.  This relationship is another important milestone in our reimbursement strategy and, when added to our recent AETNA insurance approval for ThyraMIR  and New York State approval to market ThyGenX, bodes well for our commercial prospects in 2017 and beyond."

 

About Thyroid Nodules, ThyGenX and ThyraMIR testing

 

According to the American Thyroid Association, approximately 15% to 30% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR.

 

ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules.  The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.

 

ThyGenX utilizes 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 cancer. ThyraMIR is the first microRNA gene expression classifier.  MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs.  Both ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers. 

 

About Pancreatic Cysts and PancraGEN

 

PancraGEN is a pancreatic cyst molecular test that, by using a small sample of pancreatic cyst fluid, can aid in pancreatic cancer risk assessment. PancraGEN is 90% accurate, according to clinical studies, enabling effective risk stratification of patients.  Pancreatic cancer is often difficult to diagnose in early stages and typically spreads rapidly with signs and symptoms appearing when the cancer is significantly advanced. Because of this, and that complete surgical removal of the pancreas is not possible, pancreatic cancer is considered a leading cause of cancer deaths.

 

About Interpace Diagnostics Group, Inc.

 

Interpace Diagnostics is a company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for better patient diagnosis and management. The Company currently has three commercialized molecular tests; PancraGen for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay and ThyraMIR, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay. Interpace Diagnostics' mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science.

 

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. The Company 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 the Company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company'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, our ability to adequately finance the business, our ability to restructure our debt and other obligations, our ability to meet our obligations as they become due,, the market's acceptance of our molecular diagnostic tests; our ability to secure additional business and generate higher profit margins through sales of our molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the Company'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 30, 2016 as amended on April 29, 2016 and June 14, 2016, and the Quarterly Report on Form 10-Q filed with the SEC on November 17, 2016. 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, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

 

CONTACTS:

Interpace Diagnostics Group, Inc.

Investor Relations:

Paul Kuntz – Redchip

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