Effective May 2, 2025, Interpace Diagnostics® Will No Longer Accept Specimens for PancraGEN®, a Molecular Diagnostic Test That Assesses Pancreatic Cyst Cancer Risk
Interpace Diagnostics (OTCQX: IDXG) announced the discontinuation of their PancraGEN® molecular diagnostic test for pancreatic cyst cancer risk assessment, effective May 2, 2025. This decision follows the Medicare Administrative Contractor Novitas Solutions' Local Coverage Determination ending reimbursement for the test.
The company will stop accepting specimens for PancraGEN testing after May 2, 2025, though they will continue processing tests without reimbursement between April 24 and May 2, 2025, to manage the transition. Despite PancraGEN's decade-long use in aiding pancreatic cancer diagnosis and reducing unnecessary surgeries, the loss of Medicare reimbursement makes the service unsustainable.
Interpace expects to maintain profitability through its thyroid testing franchise, ThyGeNEXT® + ThyraMIR®v2, and will implement a restructuring plan to adapt to these changes.
Interpace Diagnostics (OTCQX: IDXG) ha annunciato la cessazione del test diagnostico molecolare PancraGEN® per la valutazione del rischio di cancro alle cisti pancreatiche, a partire dal 2 maggio 2025. Questa decisione segue la determinazione di copertura locale del Medicare Administrative Contractor Novitas Solutions, che ha interrotto il rimborso per questo test.
L'azienda smetterà di accettare campioni per il test PancraGEN dopo il 2 maggio 2025, anche se continuerà a processare i test senza rimborso tra il 24 aprile e il 2 maggio 2025 per gestire la transizione. Nonostante l'utilizzo decennale di PancraGEN nel supportare la diagnosi del cancro al pancreas e nel ridurre interventi chirurgici non necessari, la perdita del rimborso Medicare rende il servizio insostenibile.
Interpace prevede di mantenere la redditività tramite la sua linea di test per la tiroide, ThyGeNEXT® + ThyraMIR®v2, e attuerà un piano di ristrutturazione per adattarsi a questi cambiamenti.
Interpace Diagnostics (OTCQX: IDXG) anunció la discontinuación de su prueba diagnóstica molecular PancraGEN® para la evaluación del riesgo de cáncer en quistes pancreáticos, efectiva a partir del 2 de mayo de 2025. Esta decisión sigue a la determinación de cobertura local del Medicare Administrative Contractor Novitas Solutions, que finalizó el reembolso para esta prueba.
La compañía dejará de aceptar muestras para la prueba PancraGEN después del 2 de mayo de 2025, aunque continuará procesando pruebas sin reembolso entre el 24 de abril y el 2 de mayo de 2025 para facilitar la transición. A pesar del uso de PancraGEN durante una década para apoyar el diagnóstico del cáncer de páncreas y reducir cirugías innecesarias, la pérdida del reembolso de Medicare hace que el servicio no sea sostenible.
Interpace espera mantener la rentabilidad a través de su franquicia de pruebas tiroideas, ThyGeNEXT® + ThyraMIR®v2, y llevará a cabo un plan de reestructuración para adaptarse a estos cambios.
Interpace Diagnostics (OTCQX: IDXG)는 2025년 5월 2일부터 췌장 낭종 암 위험 평가를 위한 분자 진단 검사 PancraGEN®의 중단을 발표했습니다. 이 결정은 Medicare 행정 계약자 Novitas Solutions의 지역 보장 결정에 따라 해당 검사에 대한 보험 급여가 종료된 데 따른 것입니다.
회사는 2025년 5월 2일 이후 PancraGEN 검사 샘플 접수를 중단할 예정이나, 전환 관리를 위해 2025년 4월 24일부터 5월 2일까지는 보험 급여 없이 검사를 계속 처리할 계획입니다. PancraGEN은 췌장암 진단 지원과 불필요한 수술 감소에 10년간 활용되었으나, Medicare 보험 급여 중단으로 인해 서비스 지속이 어려워졌습니다.
Interpace는 갑상선 검사 제품군인 ThyGeNEXT® + ThyraMIR®v2를 통해 수익성을 유지할 것으로 기대하며, 이러한 변화에 대응하기 위한 구조조정 계획을 시행할 예정입니다.
Interpace Diagnostics (OTCQX : IDXG) a annoncé l'arrêt de son test diagnostique moléculaire PancraGEN® pour l’évaluation du risque de cancer des kystes pancréatiques, à compter du 2 mai 2025. Cette décision fait suite à la détermination de couverture locale du Medicare Administrative Contractor Novitas Solutions, qui a mis fin au remboursement de ce test.
L’entreprise cessera d’accepter les échantillons pour le test PancraGEN après le 2 mai 2025, mais continuera à traiter les tests sans remboursement entre le 24 avril et le 2 mai 2025 afin de faciliter la transition. Bien que PancraGEN ait été utilisé pendant une décennie pour aider au diagnostic du cancer du pancréas et réduire les interventions chirurgicales inutiles, la suppression du remboursement Medicare rend le service non viable.
Interpace prévoit de maintenir sa rentabilité grâce à sa gamme de tests thyroïdiens, ThyGeNEXT® + ThyraMIR®v2, et mettra en œuvre un plan de restructuration pour s’adapter à ces changements.
Interpace Diagnostics (OTCQX: IDXG) hat die Einstellung ihres molekularen Diagnosetests PancraGEN® zur Bewertung des Krebsrisikos bei Pankreaszysten zum 2. Mai 2025 angekündigt. Diese Entscheidung folgt der lokalen Kostenerstattungsentscheidung des Medicare Administrative Contractor Novitas Solutions, die die Erstattung für den Test beendet hat.
Das Unternehmen wird nach dem 2. Mai 2025 keine Proben für den PancraGEN-Test mehr annehmen, wird jedoch zwischen dem 24. April und dem 2. Mai 2025 weiterhin Tests ohne Erstattung bearbeiten, um den Übergang zu erleichtern. Trotz der zehnjährigen Nutzung von PancraGEN zur Unterstützung der Diagnose von Bauchspeicheldrüsenkrebs und zur Verringerung unnötiger Operationen macht der Wegfall der Medicare-Erstattung den Service unrentabel.
Interpace rechnet damit, die Profitabilität durch sein Schilddrüsen-Testangebot ThyGeNEXT® + ThyraMIR®v2 aufrechtzuerhalten und wird einen Restrukturierungsplan umsetzen, um sich an diese Veränderungen anzupassen.
- Company expects to maintain profitability through thyroid testing business
- Structured transition period allows for orderly wind-down of PancraGEN service
- Loss of Medicare reimbursement for PancraGEN test
- Forced discontinuation of a decade-old diagnostic service
- Company restructuring required due to service termination
Interpace Expects to Remain Profitable as a Thyroid-focused Business
PARSIPPANY, NJ, April 24, 2025 (GLOBE NEWSWIRE) -- Interpace Diagnostics®, a subsidiary of Interpace Biosciences®, (“Interpace” or the “Company”) (OTCQX: IDXG) today announced that the Genetic Testing for Oncology (L39365) Local Coverage Determination (LCD) issued by the Medicare Administrative Contractor Novitas Solutions will go into effect, ending reimbursement for their PancraGEN® test. The Centers for Medicare & Medicaid Services (CMS) delayed implementation by 60 days earlier in the year and confirmed finalization of the LCD as of today, April 24, 2025.
PancraGEN is a DNA-based diagnostic molecular test. It uniquely assesses the risk of pancreatic cyst progression to cancer by integrating the results of first-line tests and procedures with molecular test results. Because PancraGEN is primarily ordered for Medicare patients, the decision to end reimbursement coverage means that Interpace will not be able to continue offering this test. Specimens for first-line fluid chemistry and PancraGEN testing will not be accepted by Interpace after May 2, 2025.
Rob Renjilian, Chief Commercial Officer for Interpace, stated, “PancraGEN has been offered for over a decade and is well-used by clinicians to aid their diagnosis of pancreatic cancer, helping to inform their optimal management of patients, including the reduction of unnecessary surgeries.” He continued, “We know that clinicians rely on our testing and understand the challenges this decision imposes on the physicians we serve—and on their patients. We will be working with them to help during this transition as best as possible.”
Tom Burnell, President and CEO of Interpace, stated, “It is extremely unfortunate that, despite compelling evidence of the utility of this test, this decision by CMS and Novitas ends reimbursement coverage for PancraGEN. This decision necessitates that we no longer accept pancreatic cyst fluid specimens for testing.” He went on to say, “We highly value the physicians we serve. However, as a publicly traded company, we are obligated to help ensure profitability for our shareholders. Without reimbursement, we cannot continue to offer the PancraGEN test indefinitely, though we will be running the test without reimbursement, for a limited period of time, between April 24, 2025 and May 2, 2025, to allow the Company time to communicate with our customers regarding this situation and to process specimens already in transit to Interpace.” Mr. Burnell then continued, “The loss of Medicare reimbursement also necessitates the restructuring of Interpace. Our plan is in place, and its implementation will continue forward. As stated previously, we believe the Company is sustainable without PancraGEN and we expect that our testing franchise for indeterminate thyroid nodules, ThyGeNEXT® + ThyraMIR®v2, will allow us to continue to remain profitable in 2025 and beyond.”
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, provide clinically useful molecular diagnostic tests and 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 three commercialized molecular tests and one test in a clinical evaluation program (CEP): ThyGeNEXT® for the diagnosis of thyroid cancer from thyroid nodules utilizing a next-generation sequencing assay; ThyraMIR®v2, used in combination with ThyGeNEXT®, for the diagnosis of thyroid cancer utilizing a proprietary microRNA pairwise expression profiler along with algorithmic classification; and RespriDX®, that differentiates lung cancer of primary versus metastatic origin. In addition, BarreGEN®, a molecular-based assay that helps resolve the risk of progression of Barrett’s Esophagus to esophageal cancer, is currently in a CEP, whereby we gather information from physicians using BarreGEN to assist us in gathering clinical evidence relative to the safety and performance of the test and also providing data that will potentially support payer reimbursement.
For more information, please visit Interpace Biosciences’ website at www.interpace.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. 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 statements, including, but not limited to, the possibility that the Company’s estimates of future revenue, cash flows and adjusted EBITDA may prove to be materially inaccurate, the Company’s prior history of operating losses, the Company’s ability to adequately finance its business and seek alternative sources of financing, the Company’s ability to repay borrowings from BroadOak, the Company’s dependence on sales and reimbursements from its clinical services, the Company’s ability to retain or secure reimbursement including its reliance on third parties to process and transmit claims to payers and the adverse impact of any delay, data loss, or other disruption in processing or transmitting such claims, the Company’s revenue recognition being based in part on estimates for future collections which estimates may prove to be incorrect, and the Company’s ability to restructure itself in light of the loss of reimbursement for its PancraGEN product.
Additionally, all forward-looking statements are subject to the “Risk Factors” detailed from time to time in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as amended, Current Reports on Form 8-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. 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:
Investor Relations
Interpace Biosciences, Inc.
(855)-776-6419
Info@Interpace.com
FAQ
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