Interpace Diagnostics® Announces Undefined Extension of Medicare Coverage for PancraGEN®, a Molecular Diagnostic Test That Assesses Cancer Risk of Pancreatic Cysts
Interpace Diagnostics, a subsidiary of Interpace Biosciences (OTCQX: IDXG), announced an undefined extension of Medicare coverage for PancraGEN, their molecular diagnostic test for pancreatic cyst cancer risk assessment. The Centers for Medicare & Medicaid Services (CMS) granted Novitas, their Medicare Administrative Contractor, an extension for the final decision on Local Coverage Determination (LCD) of Genetic Testing for Oncology (L39365), which includes PancraGEN.
PancraGEN has been used to risk-stratify pancreatic cysts for nearly 70,000 patients since 2013, helping to reduce unnecessary surgeries. The company emphasizes the test's importance in providing a complete picture of malignancy risk, as first-line diagnostic tests often fall short. Interpace plans to challenge the proposed LCD and request its retirement to ensure continued access to PancraGEN for physicians and patients.
Interpace Diagnostics, una filiale di Interpace Biosciences (OTCQX: IDXG), ha annunciato un'estensione indefinita della copertura Medicare per PancraGEN, il loro test diagnostico molecolare per la valutazione del rischio di cancro delle cisti pancreatiche. I Centers for Medicare & Medicaid Services (CMS) hanno concesso a Novitas, il loro appaltatore amministrativo Medicare, un'estensione per la decisione finale sulla Determinazione della Copertura Locale (LCD) dei Test Genetici per Oncologia (L39365), che include PancraGEN.
PancraGEN è stato utilizzato per stratificare il rischio delle cisti pancreatiche per quasi 70.000 pazienti dal 2013, contribuendo a ridurre interventi chirurgici non necessari. L'azienda sottolinea l'importanza del test nel fornire un quadro completo del rischio di malignità, poiché i test diagnostici di prima linea spesso non sono sufficienti. Interpace intende contestare la proposta di LCD e richiederne il ritiro per garantire un accesso continuo a PancraGEN per medici e pazienti.
Interpace Diagnostics, una filial de Interpace Biosciences (OTCQX: IDXG), anunció una extensión indefinida de la cobertura de Medicare para PancraGEN, su prueba de diagnóstico molecular para la evaluación del riesgo de cáncer de cist pancreaticas. Los Centros de Servicios de Medicare y Medicaid (CMS) otorgaron a Novitas, su Contratista Administrativo de Medicare, una extensión para la decisión final sobre la Determinación de Cobertura Local (LCD) de Pruebas Genéticas para Oncología (L39365), que incluye PancraGEN.
PancraGEN ha sido utilizado para estratificar el riesgo de cist pancreaticas para casi 70,000 pacientes desde 2013, ayudando a reducir cirugías innecesarias. La compañía destaca la importancia de la prueba para proporcionar una visión completa del riesgo de malignidad, ya que los exámenes diagnósticos de primera línea a menudo son insuficientes. Interpace planea impugnar la propuesta de LCD y solicitar su retiro para asegurar el acceso continuo a PancraGEN para médicos y pacientes.
Interpace Diagnostics는 Interpace Biosciences의 자회사로서 (OTCQX: IDXG), 그들의 췌장 낭종 암 위험 평가를 위한 분자 진단 검사인 PancraGEN의 Medicare 보장 무기한 연장을 발표했습니다. Medicare 행정 계약자인 Novitas는 췌장암 유전 검사에 대한 지역 보장 결정 (LCD) 최종 결정 연장을 승인했습니다 (L39365), 이에는 PancraGEN이 포함됩니다.
PancraGEN은 2013년부터 거의 7만 명의 환자의 췌장 낭종 위험을 분류하는 데 사용되어 불필요한 수술을 줄이는 데 기여했습니다. 이 회사는 일반적으로 1차 진단 검사로는 충분하지 않은 경우가 많기 때문에 악성 위험에 대한 종합적인 그림을 제공하는 테스트의 중요성을 강조합니다. Interpace는 제안된 LCD에 반대하고 PancraGEN에 대한 접근이 계속 보장될 수 있도록 철회를 요청할 계획입니다.
Interpace Diagnostics, une filiale d'Interpace Biosciences (OTCQX: IDXG), a annoncé une extension indéfinie de la couverture Medicare pour PancraGEN, son test de diagnostic moléculaire pour l'évaluation du risque de cancer des kystes pancréatiques. Les Centers for Medicare & Medicaid Services (CMS) ont accordé à Novitas, leur entrepreneur administratif Medicare, une extension pour la décision finale sur la Détermination de Couverture Locale (LCD) des Tests Génétiques pour l'Oncologie (L39365), qui inclut PancraGEN.
PancraGEN a été utilisé pour stratifier le risque de kystes pancréatiques pour près de 70 000 patients depuis 2013, aidant à réduire les chirurgies inutiles. La société souligne l'importance du test pour fournir une image complète du risque de malignité, car les tests diagnostiques de première ligne sont souvent insuffisants. Interpace prévoit de contester la LCD proposée et de demander son retrait afin d'assurer un accès continu à PancraGEN pour les médecins et les patients.
Interpace Diagnostics, eine Tochtergesellschaft von Interpace Biosciences (OTCQX: IDXG), hat eine unbestimmte Verlängerung der Medicare-Abdeckung für PancraGEN angekündigt, ihren molekulardiagnostischen Test zur Risikobewertung von Bauchspeicheldrüsenzysten. Die Centers for Medicare & Medicaid Services (CMS) haben Novitas, ihren Medicare-Verwaltungsauftragnehmer, eine Verlängerung für die endgültige Entscheidung über die örtliche Deckungsbestimmung (LCD) von genetischen Tests für Onkologie (L39365) gewährt, die PancraGEN umfasst.
PancraGEN wurde seit 2013 verwendet, um das Risiko von Bauchspeicheldrüsenzysten für fast 70.000 Patienten zu stratifizieren und damit unnötige Operationen zu vermeiden. Das Unternehmen betont die Bedeutung des Tests, ein vollständiges Bild des Malignitätsrisikos zu liefern, da Erstdiagnosetests häufig nicht ausreichen. Interpace plant, die vorgeschlagene LCD anzufechten und deren Rücknahme zu beantragen, um den fortdauernden Zugang zu PancraGEN für Ärzte und Patienten zu gewährleisten.
- Undefined extension of Medicare coverage for PancraGEN test
- PancraGEN has been used for risk-stratification in nearly 70,000 patients since 2013
- Increasing utilization of PancraGEN testing services
- Uncertainty regarding final decision on Local Coverage Determination (LCD) for PancraGEN
- Potential non-coverage decision could result in unnecessary surgeries and increased healthcare costs
- Company needs to challenge proposed LCD to maintain coverage
PARSIPPANY, NJ, July 29, 2024 (GLOBE NEWSWIRE) -- Interpace Diagnostics®, a subsidiary of Interpace Biosciences®, (“Interpace” or the “Company”) (OTCQX: IDXG) today responded to the undefined extension granted by Centers for Medicare & Medicaid Services (CMS) to Novitas, its Medicare Administrative Contractor (MAC).
Novitas announced late last week that CMS granted an extension to the final decision for Local Coverage Determination (LCD) of Genetic Testing for Oncology (L39365) in order for all comments received in response to the proposed changes to be thoroughly considered.
LCD (L39365) includes PancraGEN®, 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.
Dr. Nicole Massoll, Chief Medical Officer for Interpace Diagnostics, stated, “We are extremely pleased that this extension allows us to provide PancraGEN to physicians and their patients for the foreseeable future, helping to ensure fully informed and optimized treatment decisions for a very serious and difficult to diagnose condition.”
Because of the high mortality rate of pancreatic cancer, surgery is often performed as a cautious approach to treat suspicious pancreatic cysts. Yet studies have shown that
Dr. Massoll continued, “Offered since 2013, PancraGEN has provided risk-stratification of pancreatic cysts for almost 70,000 patients and has helped to inform optimal patient management, including the reduction of unnecessary surgeries for suspicious cysts.”
According to Tom Burnell, President and CEO of Interpace, “Our unique approach to integrating molecular and first-line test results to risk-stratify pancreatic cysts is highly valued by clinicians, as demonstrated by a marked increase in utilization of our testing services.” Mr. Burnell continued, “This ever-increasing utilization is driven by the medical and scientific communities’ growing understanding of molecular genetics, which is changing the standards of patient care. Because a non-coverage decision will result in unnecessary surgeries and added healthcare costs, it is imperative that PancraGEN is able to be continually offered without interruption. As such, we will continue to vigorously challenge the proposed LCD (L39365) and request that it be immediately retired.”
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 five commercialized molecular tests and one test in a clinical evaluation program (CEP): PancraGEN® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; PanDNA®, a “molecular only” version of PancraGEN that provides physicians a snapshot of a limited number of factors; 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 reimbursement of the Company’s tests being subject to review by CMS, the possibility that the Company’s estimates of future revenue, cash flows and adjusted EBITDA may prove to be materially inaccurate, the Company’s 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 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 possible removal of the Company’s common stock from trading on the OTCQX®.
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, 2023, 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
What is the current Medicare coverage status for Interpace Diagnostics' PancraGEN test?
How many patients has PancraGEN been used for since its introduction in 2013?
What is Interpace Diagnostics' plan regarding the proposed LCD for PancraGEN?
What is the potential impact of a non-coverage decision for PancraGEN?
