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Interpace Biosciences Inc (IDXG) delivers molecular diagnostic innovations that transform cancer risk assessment through advanced mutational analysis. This news hub provides investors and healthcare professionals with essential updates on the company’s scientifically validated testing solutions.
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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 Biosciences (IDXG) reported preliminary Q4 and full-year 2024 results, highlighting record-breaking performance across key metrics. The company achieved a 21% year-over-year increase in Q4 Molecular Volume and a 17% increase for the full year, leading to double-digit revenue growth in both periods.
The company reached all-time highs in test volume, revenue, income, and cash collections for both Q4 and FY2024. Their ThyGeNEXT® + ThyraMIR®v2 testing services for indeterminate thyroid nodules showed particularly strong physician demand, significantly contributing to profitability.
While maintaining a positive outlook for 2025, management acknowledged uncertainty regarding PancraGEN® Medicare reimbursement, but indicated preparedness for potential non-coverage determination, emphasizing the strength and profitability of their Endo business unit as a solid foundation.
Interpace Diagnostics (OTCQX: IDXG) announced that the Centers for Medicare & Medicaid Services (CMS) has delayed the implementation of the Genetic Testing for Oncology Local Coverage Determination (LCD) from February 23, 2025, to April 24, 2025. This delay affects PancraGEN®, a DNA-based molecular diagnostic test that assesses pancreatic cyst cancer risk.
The extension allows the incoming Trump administration to review the proposed policy changes and evaluate the clinical evidence for PancraGEN, which has been Medicare-covered for over 10 years and has helped more than 80,000 patients. The test helps physicians determine optimal treatment plans and reduce unnecessary surgeries.
While Interpace can sustain operations without PancraGEN through its thyroid nodule testing franchise (ThyGeNEXT® + ThyraMIR®v2), the delay allows the company to continue offering PancraGEN and related Point2® fluid chemistry tests while preserving jobs for employees involved in specimen processing.
Interpace Diagnostics (OTCQX: IDXG) announced it will discontinue its PancraGEN® molecular diagnostic test effective February 7, 2025, following a Centers for Medicare & Medicaid Services (CMS) decision to end coverage. The test, which has helped over 80,000 patients assess pancreatic cyst cancer risk since 2013, will no longer be viable as it primarily serves Medicare patients.
The decision comes through a final Local Coverage Determination (LCD) issued by CMS's Medicare Administrative Contractor, Novitas. According to CEO Tom Burnell, this decision may lead to unnecessary surgeries and increased healthcare costs. Despite this setback, Interpace expects to remain profitable through its thyroid nodule testing franchise, ThyGeNEXT® + ThyraMIR®v2.
Interpace Biosciences (IDXG) reported strong Q3 2024 financial results with record-breaking performance. Revenue reached $12.3 million, up 35% year-over-year, while test volume increased 26%. The company achieved $11.3 million in cash collections, a 15% increase from Q3 2023. Operating costs per test decreased by 11%, and gross profit margin improved to 61%. Income from continuing operations was $1.4 million, marking a $1.9M improvement from the previous year. The company's molecular diagnostics tests showed double-digit growth, marking the eighteenth consecutive quarter of year-over-year volume growth. Management indicated plans to seek additional capital and pursue Nasdaq listing.
Interpace Biosciences (OTCQX: IDXG) has announced a capital restructuring of its preferred stock as a first step towards seeking an uplisting of its common stock to Nasdaq. The company's Series B Preferred Stock investors, Ampersand Capital Partners and 1315 Capital, have exchanged their existing 47,000 shares for newly created Series C Preferred Stock.
The new Series C Preferred Stock has a conversion price of $2.02 into common stock and will automatically convert upon a Nasdaq uplisting. It eliminates certain rights associated with the Series B stock, including liquidation preference, director designation rights, and specific protective voting rights.
This restructuring is aimed at adjusting Interpace's capital structure to facilitate raising growth capital. The company believes a Nasdaq listing would help in raising additional capital, increasing investor interest, and pursuing acquisitions.
Interpace Biosciences (OTCQX: IDXG) reported record Q2 2024 financial results, with revenue reaching $12.0 million, a 9% increase year-over-year. Key highlights include:
- Test volume up 12% to record levels
- Cash collections increased 7% to $11.0 million
- Income from continuing operations improved to $2.1 million
- Operating expenses reduced by 14% compared to Q2 2023
The company's growth was driven by increased adoption of its proprietary molecular diagnostics tests. Adjusted EBITDA rose to $2.3 million, up from $1.3 million in the prior-year quarter. Despite a lower cash balance of $2.0 million due to $4.6 million in debt repayment, Interpace achieved its sixteenth consecutive quarter of year-over-year volume growth.
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 announced new data on advanced sequencing technologies for pancreatic cancer detection, published as an e-abstract at the 2024 ASCO Annual Meeting. The findings, detailed in Abstract e16359, emphasize the role of short tandem repeats (STRs) in cancer biology. The study compares traditional methods like capillary electrophoresis (CE) with newer technologies such as second-generation short-read sequencing (NGS) and third-generation long-read sequencing (TGS). While CE remains the gold standard for STR analysis, NGS faces challenges in accuracy. This research underscores the importance of sequencing platform selection and highlights its impact on understanding cancer mechanisms.
Interpace Biosciences, Inc. announced Q1 2024 financial results with a $10.3 million revenue, a 4% YoY increase, and a 10% test volume growth. Operating expenses decreased by 2%, with income from continuing operations at $0.6 million. The company experienced record test volume, cash collections, and profitability, fuelled by increased adoption of molecular diagnostics tests. Despite a slight decrease in gross profit percentage and adjusted EBITDA, the company maintained a strong financial position with $2.8 million cash balance.
