Interpace Diagnostics Announces Coverage of Its Thyroid Assays by Blue Shield of California

Major California-Based Health Plan Adds Coverage for Both ThyGenX® & ThyraMIR®

PARSIPPANY, N.J., April 02, 2018 (GLOBE NEWSWIRE) -- Interpace Diagnostics Group, Inc. (NASDAQ:IDXG) (“Interpace” or “the Company”), a fully integrated commercial and bioinformatics company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management, today announced that Blue Shield of California, a health plan provider founded in 1939 and based in San Francisco and serving over 4 million health plan members and 65,000 physicians across the state, has agreed to cover Interpace’s combination thyroid molecular-based tests, ThyGenX and ThyraMIR. 

Blue Shield of California, which has been recognized as one of the 2018 world’s most ethical companies by the Ethisphere® Institute, published positive medical policy coverage for Interpace’s ThyGenX and ThyraMIR assays for thyroid nodules deemed indeterminate by standard cytopathological analysis effective March 1, 2018. 

Blue Shield of California marks the eighth Blue Cross Blue Shield plan to grant positive coverage for ThyGenX and ThyraMIR since the start of 2018. Interpace has successfully achieved positive medical coverage for its services through Medicare as well as other leading National and Regional health plans. With the addition of the plans announced earlier in the first quarter, Blue Shield of CA brings the total number to 285 million covered lives for ThyGenX and ThyraMIR.

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.

According to Jack Stover, President & CEO of Interpace, “Blue Shield of California’s coverage of both ThyGenX and ThyraMIR continues the favorable trend among BCBS plans to extend coverage of our valuable thyroid products to their members.  In the past, most of our business with BCBS plans has resulted in “0 pays” for us, so it is nice to see this significant turnaround. Further, we are very pleased that approximately an additional 4 million patients and 65,000 physicians now have the opportunity to receive the demonstrated benefits of our molecular tests for indeterminate thyroid nodules.”

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.  Both ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers. 

About Interpace Diagnostics Group, Inc.

Interpace is a fully integrated commercial and bioinformatics 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 improved patient diagnosis and management. The Company currently has four commercialized molecular tests and one test in a clinical evaluation process (CEP); 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; ThyraMIR® for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay; and RespriDX™ that differentiates lung cancer of primary vs. metastatic origin. BarreGEN® for Barrett's Esophagus, is currently being “soft launched” with key opinion leaders as we continue to gather data on this assay that will assist us in seeking favorable reimbursement as well as important clinical information. [Barrett's Esophagus is a rapidly growing diagnosis that affects over three million people in the US and over time can progress to esophageal cancer.] The Company’s data base includes data from over 45,000 patients who have been tested using the Company’s current products, including over 15,000 molecular tests for thyroid nodules. Interpace has been designated as one of the top 20 companies for providing bioinformatics solutions. Interpace’s mission is to provide personalized medicine through molecular diagnostics, innovation and data to advance patient care based on rigorous science. For more information, please visit Interpace’s website at www.interpacediagnostics.com

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, 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 history of losses, the Company's ability to adequately finance the business, 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 SEC filings, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed on March 23, 2018, Quarterly Reports on Form 10-Q and other SEC filings. 

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
(412) 708-4590
paul@redchip.com

Released April 2, 2018