Interpace Announces Acceptance of Seminal Clinical Validation Study for Thyroid Assays
Podium Presentation Accepted for the American Society of Cytopathology (ASC) Annual Meeting
PARSIPPANY, NJ, July 21, 2020 (GLOBE NEWSWIRE) -- Interpace Biosciences, Inc. (NASDAQ: IDXG) announced today that a peer-reviewed manuscript describing results from a seminal clinical validation study of the combination of ThyGeNEXT® and ThyraMIR® has been accepted for publication in the highly respected journal, Diagnostic Cytopathology. The study, led by Dr. Mark Lupo from the Thyroid and Endocrine Center of Florida, reported on the ability of the combination of ThyGeNEXT®/ThyraMIR® tests to successfully stratify nearly 200 indeterminate thyroid nodules for risk of malignancy. Sites participating in this multicentered study included Cedars-Sinai Medical Center, Jackson Thyroid & Endocrine Clinic, University of Michigan, Massachusetts General Hospital/Harvard Medical School, and the University of Arkansas for Medical Sciences.
According to Jack Stover, President and CEO of Interpace, “We’re excited that this important study will soon be published in such a prominent peer reviewed journal and will be further highlighted at the ASC Annual Meeting in November.” He continued “We look forward to sharing these results with the physician and payer communities shortly.”
About ThyGeNEXT® and ThyraMIR®
ThyGeNEXT® is Interpace’s most recent next generation sequencing test that was expanded from its original version (ThyGenX®) to include markers that have targeted therapies and those that can identify aggressive forms of thyroid cancer.
ThyGeNEXT® 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, as well as Medullary Thyroid Carcinoma. 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 ThyGeNEXT® and ThyraMIR® are covered by Medicare and Commercial insurers, with more than 280 million members covered.
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 ThyGeNEXT® and ThyraMIR®.
ThyGeNEXT® 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.
About Interpace Biosciences
Interpace Biosciences is an emerging leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.
Clinical services, through Interpace Diagnostics, provides clinically useful molecular diagnostic tests, bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Interpace 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; ThyGeNEXT® 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. In addition, BarreGEN® for Barrett’s Esophagus, is currently in a clinical evaluation program whereby we gather information from physicians using BarreGEN® to assist us in positioning the product for full launch, partnering and potentially supporting reimbursement with payers.
Pharma services, through Interpace Pharma Solutions, provides pharmacogenomics testing, genotyping, biorepository and other customized services to the pharmaceutical and biotech industries. Pharma services also advance personalized medicine by partnering with pharmaceutical, academic, and technology leaders to effectively integrate pharmacogenomics into their drug development and clinical trial programs with the goals of delivering safer, more effective drugs to market more quickly, and improving patient care.
For more information, please visit Interpace Biosciences’ website at www.interpace.com.
The American Society of Cytopathology (ASC), founded in 1951, is a 3,000 member distinguished national professional society of physicians, cytotechnologists and scientist who are dedicated to the cytologic method of diagnostic pathology. The ASC’s diverse membership includes representatives from other countries who share a vision of education, research and continuous improvement in the standards and quality of patient care. The ASC is a unique society that provides a forum where physicians and cytotechnologists can interact and network with each other on both a personal and professional level.
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Released July 21, 2020