Interpace Diagnostics Announces Increased Reimbursement for ThyGenX®

CMS Evaluation Results in 40% Increase in Medicare Reimbursement

PARSIPPANY, N.J., Oct. 11, 2017 (GLOBE NEWSWIRE) -- 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 reimbursement for its ThyGenX® molecular test for indeterminate thyroid nodules will increase by 40% starting January 1, 2018. 

Medicare has covered ThyGenX since 2015, and in January 2016, Medicare initiated coverage of ThyraMIR®, the Company’s miRNA-based product.  Overall, Medicare represents approximately 40% of the Company’s volume for the ThyGenX test; given the Company’s recent announcements of coverage for ThyGenX among numerous commercial health plans, the overall payer mix for the remainder of the volume has improved significantly since 2016. These commercial plans include Cigna, Aetna, United Healthcare, and Oxford.  Including Medicare, the total number of covered lives for Interpace’s ThyGenX molecular test for indeterminate thyroid nodules is now approximately 275 million patients nationwide.

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. 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, over 70% of these surgical outcomes are ultimately benign.  Molecular testing using ThyGenX has been shown to reduce the rate of unnecessary surgeries in indeterminate cases.

Jack E. Stover, President and CEO of Interpace Diagnostics stated, “We are pleased that Medicare has recognized the value ThyGenX provides to both physicians and their patients as we continue to make strides in improving reimbursement.”

About Thyroid Nodules and ThyGenX 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.

ThyGenX yields high predictive value in determining the presence of cancer in thyroid nodules.  The test can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer. ThyGenX is covered by both Medicare and many 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 four commercialized molecular tests; PancraGen® for the diagnosis and prognosis of pancreatic cancer; ThyGenX, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay and ThyraMIR®, for the diagnosis of thyroid cancer utilizing a proprietary gene expression assay and MVPdX™, a test that differentiates local recurrence of cancer versus new primary cancer formation. 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 the Company's 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, the Company's ability to adequately finance the business, its ability to restructure its liabilities and other obligations, the market's acceptance of its molecular diagnostic tests, its ability to retain or secure reimbursement, its ability to secure additional business and generate higher profit margins through sales of its molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments and its ability to maintain its NASDAQ listing.. Additionally, all forward-looking statements are subject to the “Risk Factors” detailed from time to time in the Company's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

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
paul@redchip.com

Released October 11, 2017