Interpace Diagnostics Announces New York State Approval of New Product
New York State Issues License for Marker of Aggressiveness in Thyroid Cancer
PARSIPPANY, N.J., Nov. 16, 2017 (GLOBE NEWSWIRE) -- Interpace Diagnostics Corp. (NASDAQ:IDXG), a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management, announced today that the New York State Department of Health has reviewed and approved for marketing the Company’s TERT service offering, which can be ordered in conjunction with the Company’s ThyGenX molecular panel or on a stand-alone basis. While the Company currently markets both ThyGenX and ThyraMIR® in New York State, until now the TERT offering has been awaiting New York State approval. The TERT marker is a strong molecular predictor of the aggressiveness of thyroid cancer and adds additional insights into a patient’s molecular profile.
Currently, the ThyGenX mutation panel includes the following markers that are predictive of thyroid cancer from cytologically indeterminate thyroid nodules, including BRAF, HRAS, KRAS, NRAS, RET/PTC, PAX8/PPARy, and PIK3CA. By adding TERT, the panel not only acts as a strong predictor of thyroid cancer, but also provides evidence that a positive result indicates the cancer is more likely to be more aggressive, enabling physicians to make the most informed surgical choice possible. The Company currently provides ThyGenX and ThyraMIR testing to over 250 hospitals and 500 physicians nationwide. The Company has performed over 15,000 ThyGenX/ThyraMIR tests and recently presented data at the American Thyroid Association’s Annual Meeting in Vancouver, British Columbia using data from this patient cohort demonstrating the performance of these assays in a real world clinical setting.
According to Jack Stover, President and CEO of Interpace Diagnostics, “The addition of TERT to our ThyGenX assay is a potential game changer given the fact that no other diagnostics company has been able to successfully incorporate the TERT biomarker into a combination testing algorithm product offering. Further, TERT is well recognized as one of the most aggressive biomarkers for thyroid cancer. The prompt recognition and approval by New York State is a strong indication of the importance of making this vital insight available to New York State’s residents, patients and physicians.”
Telomerase reverse transcriptase or TERT encodes the reverse transcriptase component of telomerase, which adds telomere repeats to chromosome ends, enabling cell replication. Published data suggests that TERT mutations can extend the life span of the tumor cell and allow time for other mutations to develop. Mutations in the TERT promoter region are found in thyroid cancers and seem to act synergistically when they occur with the BRAF V600 mutation. The coexistence of mutations in TERT and BRAF genes has been shown to dramatically increase the risk of thyroid cancer aggressiveness, tumor recurrence, and thyroid cancer-specific deaths.
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.
The Company first launched ThyGenX in October, 2014 and initially launched the TERT offering in all other markets in July, 2017. ThyraMir, the Company’s miRNA based classifier, was launched on April 15th, 2015 making it available to Endocrinologists and Pathologists throughout the U.S.
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 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.
Source: Interpace Diagnostics Group, Inc.
Released November 16, 2017