Interpace Biosciences Inc. (IDXG)

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Interpace Diagnostics Announces Coverage of Thyroid Test By Premera Blue Cross


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, today announced that Premera Blue Cross, the largest Regional health plan based in Mountlake Terrace, Washington, has agreed to cover Interpace’s ThyraMIR® test for all of its more than 2 million members located primarily in Washington, Oregon, and Alaska. Premera Blue Cross has a network of more than 38,000 physicians, hospitals, laboratories, and other healthcare providers across the Northwest. Interpace’s ThyraMIR assay is now covered for thyroid nodules deemed indeterminate by standard cytopathological analysis. With the addition of Premera’s members, ThyraMIR is now covered for over 250 million patients nationwide, including through Medicare, National, and Regional health plans. The Company also recently announced coverage of ThyraMIR by United Healthcare and Aetna.
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, “The agreement by Premera Blue Cross to cover ThyraMIR is further evidence of the clinical utility as well as clinical validity of our thyroid assays. We are pleased that Premera has joined the growing list of health plans that cover ThyraMIR and that their 2 million members 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. Both 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 innov