Interpace Diagnostics Announces Coverage of Thyroid Test by Oxford Health Plans

PARSIPPANY, N.J., Aug. 16, 2017 -- Interpace Diagnostics Group, Inc. (NASDAQ:IDXG) (“Interpace” or “the Company”), a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management, announced today that Oxford Health Plans will cover Interpace’s ThyraMIR® test for indeterminate thyroid nodules effective August 1, 2017.   Oxford Health Plans, a UnitedHealthcare company, offers health care benefits to employers and individuals primarily in New York, New Jersey, and Connecticut making it one of the largest health plans in the heavily populated tri-state Region.  Oxford's commercial insured products and services include traditional health maintenance organizations, preferred and exclusive provider organizations, point-of-service plans and consumer-driven health plans.  In addition, Oxford also offers Medicare plans and third-party administration of employer-funded benefits plans. 

With the addition of Oxford’s members, ThyraMIR is now covered for over 250 million lives nationwide, including through Medicare, National, and Regional health plans. This follows the Company’s recent announcement of its National contract with Aetna for its ThyGenX® and ThyraMIR products along with the approval by Cigna of ThyGenX.

 

The ThyGenX® - ThyraMIR® combination represents the only test in the market that includes the rule-in properties of next-generation sequencing of a patient’s DNA and RNA along with the rule-out capabilities of a micro-RNA classifier to provide physicians with clinically actionable test results. Based on current performance, approximately 90% of the Company’s ThyGenX cases are reflexed to ThyraMir for additional assessment.  The Company first launched ThyraMIR on April 15, 2015 making it available to Endocrinologists and Pathologists throughout the country.  Since then, the Company has conducted over 15,000 ThyraMIR tests for nearly 400 physicians and hospitals nationwide.

 

According to the American Cancer Society, thyroid cancer is the most rapidly increasing cancer in the U.S., tripling in the past three decades. Most physicians have traditionally recommended thyroid surgery where thyroid nodule biopsy results are indeterminate, not clearly benign or malignant, following traditional cytopathology review; however, 70%-80% of these surgical outcomes are ultimately benign.  Molecular testing using ThyGenX – ThyraMIR has been shown to reduce the rate of unnecessary surgeries in indeterminate cases.

 

Jack E. Stover, President and CEO of Interpace Diagnostics stated, “Oxford’s determination to cover ThyraMIR follows a steady stream of payers that have recognized the value that both of our Thyroid products play in identifying the appropriate patients for surgery.” “We are pleased that Oxford has joined the growing list of health plans that cover ThyraMIR and their  members in New York, New Jersey, and Connecticut will now have access to its benefits.”

 

About Thyroid Nodules, ThyGenX and ThyraMIR Testing

 

According to the American Thyroid Association, approximately 20% 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.  ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers. 

 

About Interpace Diagnostics Group, Inc.

 

Interpace Diagnostics is a fully integrated commercial 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 liabilities and other obligations, the market's acceptance of our molecular diagnostic tests; our ability to retain or secure reimbursement, 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 and our ability to maintain our NASDAQ listing. 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 31, 2017 and the amendment on Form 10-K/A filed on April 28, 2017, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 filed with the SEC on May 12, 2017, and the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 filed with the SEC on August 10, 2017. 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

Investor Relations:

Paul Kuntz – RedChip

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