Parsippany, NJ, April 5, 2021 (GLOBE NEWSWIRE) – Interpace Biosciences, Inc. (“Interpace” or the “Company”) (OTCQX: IDXG) today announced that Novitas, its Medicare administrative contractor, has approved the new Proprietary Laboratory Analysis (PLA) code that specifically identifies ThyGeNEXT as a separate test from any other test or service. PLA codes are in addition to current procedural terminology (CPT) code set approved by the American Medical Association CPT Editorial panel. PLA codes are alphanumeric CPT codes with an associated descriptor for laboratories looking to identify their test more specifically. The new PLA code for ThyGeNEXT is 0245U and the reimbursement for this code remains at $ 2,919, which represents a significant price increase from the previous reimbursement level of $ 560. In December 2020, Novitas issued a new local coverage provision (LCD) for ThyGeNEXT this reflects the enhanced mutation panel of the assay. In 2020, Interpace processed approximately 15,000 ThyGeNEXT tests for more than 700 doctors.
More information on the billing and coding article related to this change is available on the Centers for Medicare & Medicaid Services (CMS) website under Biomarkers for Oncology (A52986). The change to the code will be officially published online when Novitas updates their website on April 22nd, 2021.
According to Tom Burnell, President and CEO of Interpace, “This is an important milestone for our company; it not only shows the increased value that ThyGeNEXT provides physicians and their patients, but acknowledges the improvements that have been made to the test since it was first developed and launched. He continued, “This newly created code will also bring incremental financial value to the business as we roll out the new code and associated compensation.”
About ThyGeNEXT and ThyraMIR
ThyGeNEXT uses state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic changes associated with papillary and follicular thyroid carcinomas, the two most common types of thyroid cancer, and medullary thyroid carcinoma. ThyraMIR is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate the expression of genes involved in human cancers, including any thyroid cancer subtype. ThyraMIR measures the expression of 10 microRNAs. Both ThyGeNEXT and ThyraMIR are covered by Medicare and commercial insurers, with more than 280 million covered members.
According to the American Thyroid Association, approximately 20% of the 525,000 thyroid aspirations (FNAs) performed annually in the U.S. cannot be identified for malignancy based on a standard cytological evaluation, and are therefore candidates for ThyGeNEXT and ThyraMIR
ThyGeNEXT and ThyraMIR reflex assays provide a 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, providing specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.
Clinical services through Interpace Diagnostics provide clinically useful molecular diagnostic testing, bioinformatics and pathology services for cancer risk evaluation by leveraging the latest personalized medicine technology to better diagnose and treat patients. Interpace has five commercialized molecular tests and one test in a clinical evaluation process (CEP): PancraGEN for the diagnosis and prognosis of pancreatic cancer due to pancreatic cysts; PanDNA, a “molecular only” version of PancraGEN that gives doctors a snapshot of a limited number of factors; ThyGeNEXT for the diagnosis of thyroid cancer from thyroid nodules using a next generation sequencing assay; ThyraMIR for the diagnosis of thyroid cancer from thyroid nodules using a proprietary gene expression assay; and RespriDX that distinguishes between lung cancer of primary and metastatic origin. In addition, BarreGEN, a molecular test that helps solve the risk of progression from Barrett’s esophagus to esophageal cancer, is currently in a clinical evaluation program (CEP) where we collect information from physicians using BarreGEN to assist us in gathering clinical evidence regarding test safety and performance and to provide data that may support payer reimbursement.
Pharma services, through Interpace Pharma Solutions, provide pharmacogenomic testing, genotyping, biorepository and other tailor-made services to the pharmaceutical and biotech industry. Pharma Services also promotes personalized medicine by partnering with pharmaceutical, academic and technology leaders to effectively integrate pharmacogenomics into their drug development and clinical trial programs with the goal of bringing safer, more effective drugs to market faster while improving patient care.
For more information, visit the Interpace Biosciences website at www.interpace.com
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, regarding the Company’s future financial and operational performance. The company has attempted to identify forward-looking statements using terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “projects”, “plans”, “potential”, ” may “,” could “,” “could”, “will”, “would”, “about” or other words that convey uncertainty about future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties regarding 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 outside the company’s control. These statements also include known and unknown risks, uncertainties and other factors that could cause the company’s actual results to differ materially from those to be n expressed or implied by forward-looking statements, including, but not limited to, the negative impact of the COVID-19. pandemic on the Company’s business and income, the significant doubts about the Company’s ability to continue as a going concern, the possibility that the Company’s estimates of future income may prove materially inaccurate, the history of the Company’s operating losses Company, the Company’s ability to finance its operations, the Company’s ability to repay its $ 5 million secured bridging loan, the Company’s reliance on sales and reimbursements of its clinical services, the Company’s ability to maintain or secure refund, including its reliance on third parties to process and pass on claims to payers and the adverse consequences of any delay, loss of data or other disruption to processing or transmission g such claims, affecting the Company’s revenue recognition is partially based estimates for future collections where the estimates may prove inaccurate, and the Company’s ability to address material weaknesses in internal controls. In addition, all forward-looking statements are subject to the “Risk Factors” described from time to time in the company’s annual report on Form 10-K for the fiscal year ended December 31, 2020, filing with the Securities and Exchange Commission, Current Reports on Form 8-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 required by law, the company assumes no obligation to revise or publicly update forward-looking statements for any reason.
Joseph Green / Megan Paul
(646) 653-7030 / 7034
jgreen @ edisongroup.com / mpaul @ edisongroup.com