Core Insights - Oncocyte Corp. has announced a positive update regarding the pricing of its next-generation lab-developed test (LDT), GraftAssureCore, which enhances its position in the transplant rejection testing market and indicates potential growth in its estimated $1 billion total addressable market [1][6] Pricing and Reimbursement - The Centers for Medicare & Medicaid Services (CMS) has increased the reimbursement rate for GraftAssureCore to $2,753 per result, up from $2,222 for first-time testing and $1,029 for subsequent tests [2] - This new pricing aligns with existing competitive technologies and expands market appeal for future FDA-cleared kitted products at transplant centers [6] Company Strategy and Future Prospects - Oncocyte has invested significantly in improving the scalability and manufacturability of its workflow, which supports its kitted test program [3] - The new reimbursement rate establishes a benchmark for future kitted tests, such as GraftAssureDx, which is expected to be submitted for FDA review by the end of the year [3] - The company anticipates that receiving FDA authorization will enable broader adoption of its technology, allowing transplant centers to access high-quality, FDA-cleared kits with established reimbursement [4] Clinical Trials and Market Engagement - Oncocyte has received approval from a Central Institutional Review Board for its clinical trial, with final preparations underway at participating transplant centers [4] - The company expects participation from three of the top 10 U.S. transplant centers, representing nearly 10% of annual U.S. transplant volume [4] Technology and Market Position - Oncocyte's technology quantifies donor-derived cell-free DNA (dd-cfDNA), which has been established as a trusted biomarker for transplant rejection [5] - The company is rebranding its test portfolio under the GraftAssure brand, with GraftAssureCore being the new name for its previously marketed VitaGraft assay [5]

Core Insights - Veracyte's shares have increased by 30.9% over the past year, outperforming the industry's decline of 13.1% and the S&P 500's gain of 12.1% [1] - The company holds a Zacks Rank 3 (Hold) and continues to benefit from the strong performance of its Afirma and Decipher tests, indicating promising future growth potential [1] Company Overview - Veracyte, based in San Francisco, CA, specializes in advanced genomic tests that enhance diagnostic, prognostic, and treatment decisions for cancer and other complex diseases, ultimately helping patients avoid unnecessary procedures [2] - The company provides tests through its central laboratories in the U.S. while expanding global access via partnerships with local labs [2] Growth Catalysts - The increase in share price is attributed to the strong performance of Afirma and Decipher Prostate tests, with Afirma test volumes growing by 10% in Q1 2025, totaling approximately 15,500 tests [3] - The growth was primarily driven by deeper penetration into existing accounts and the addition of significant new customers [3] - Decipher has experienced a remarkable adoption rate, with a record volume growth of 37% year over year, resulting in nearly 22,600 tests and a 33% revenue growth in Q1 2025 [4] - Veracyte is expanding its tests to cover the entire prostate cancer risk spectrum, with plans to launch into this expanded population in the first half of 2025 [5] Financial Estimates - The Zacks Consensus Estimate for Veracyte's 2025 earnings per share (EPS) has increased by 18.5% to $1.28, with projected revenues growing by 10.7% to $493.3 million in 2025 and reaching $542.8 million in 2026 [8]

Clinical Paper Published in BMC Veterinary Research HENDERSON, Nev., May 19, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces the publication of "Evaluation of plasma nucleosome concentrations and the effect of pre-analytical variables in healthy cats" in BMC Veterinary Research. This is the first study to report the detection of nucleosomes in cats: previously nucleosome levels have been shown to increase in dogs and humans in ...

Core Insights - Mainz Biomed N.V. plans to provide an interim readout of its eAArly DETECT 2 feasibility study by the end of summer 2025, with top-line results expected in Q4 2025 [1][2] - The study aims to validate a next-generation colorectal cancer screening test that combines proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test on approximately 2,000 average-risk patients [1][3] - The company is on track to initiate its U.S. pivotal trial, ReconAAsense, in 2026 based on the outcomes of the eAArly DETECT 2 study [2][3] Study Details - The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025, targeting the reporting of top-line results by Q4 2025 [2] - The study will evaluate the effectiveness of five novel mRNA biomarkers acquired from Sherbrooke University in 2022, which have shown the ability to identify advanced adenomas and early-stage colorectal cancer [3] Company Mission - The company aims to advance its mission of eliminating colorectal cancer and reducing global cancer mortality rates through precise detection of advanced precancerous lesions and early-stage colorectal cancer [3]

Financial Performance - Revenues for Q1 2025 were $4.9 million, up 43% year over year, but down 9.5% from Q4 2024, reflecting seasonal pressures in the healthcare industry [5][6][30] - Adjusted EBITDA improved by 92%, with a loss of $108,000 compared to a loss of $1.4 million in Q1 of the previous year [5][6] - Cash used in operations improved by 93%, with a cash reduction of $44,000 in Q1 2025, down from $667,000 in Q1 2024 [6][30] - Net cash used for the quarter was $372,000, a 49% improvement year over year [6] Business Line Performance - The pathology services division saw test volume increase by 46% and revenue grow by 53% year over year, with 11 new physicians utilizing services [8][18] - Pathology gross margin increased from 24% to 42% year over year due to increased case volume and scale efficiencies [9][12] - The product division's gross margin improved from 37% to 51% year over year, driven by operational efficiencies [21][24] Market Data - The company expects to see a rebound in Q2 2025 and anticipates returning to positive cash flow in either Q2 or Q3 [6][30] - The recent overturning of the FDA ruling on laboratory developed tests has led to renewed interest from prospective customers, which is expected to drive growth in product revenues [19][21] Company Strategy and Industry Competition - The company is focused on operational efficiency, improved cost management, and strategic investments in equipment and talent to drive growth [12][15] - The pathology services division is critical for the development of the product division, enabling continuous testing and product development at low costs [18][24] Management Comments on Operating Environment and Future Outlook - Management noted that seasonal pressures are typical in the healthcare industry, particularly in diagnostics, and they expect a rebound in Q2 [6][30] - The company anticipates revenue growth to continue in Q2 and accelerate in the second half of the year, particularly on the product side [30] Other Important Information - The company received $1.1 million through Change Healthcare's temporary funding assistance program due to a cyber attack that affected billing processes [27][28] - The company also received over $400,000 in COVID relief funds from the treasury, contributing to nonrecurring income [29][30] Q&A Session Summary - No specific questions or answers were provided in the content regarding the Q&A session.

Financial Performance - Revenues for Q1 2025 were $4.9 million, up 43% year over year, but down 9.5% from Q4 2024, reflecting seasonal pressures typical in the healthcare industry [4][5] - Adjusted EBITDA improved by 92%, with a loss of $108,000 compared to a loss of $1.4 million in Q1 of the previous year [4] - Cash used in operations improved by 93%, with a cash reduction of $44,000 in Q1 2025, down from $667,000 in Q1 2024 [5] - Net cash used for the quarter was $372,000, a 49% improvement year over year [5] Business Line Performance - The pathology services division saw test volume increase by 46% and revenue grow by 53% year over year, with 11 new physicians utilizing services [7] - Pathology gross margin increased from 24% to 42% year over year due to increased case volume and scale efficiencies [9] - The product division's gross margin improved from 37% to 51% year over year, driven by operational efficiencies and cost management [22] Market Developments - The company received MoDx approval for next-generation sequencing (NGS) testing, which is expected to increase revenue by approximately $250,000 per quarter from existing case volumes [16][18] - The FDA ruling on laboratory developed tests (LDPs) was overturned in March 2025, alleviating uncertainty and allowing prospective customers to proceed with product adoption [21][22] Strategic Direction - The company aims to return to positive cash flow in Q2 or Q3 2025, driven by higher pathology volumes and increased product sales [32] - Continued investment in state-of-the-art equipment and staff training is expected to enhance operational efficiency and improve margins [13][14] Management Commentary - Management noted that seasonal pressures are typical in the healthcare industry, particularly in diagnostics, and expressed confidence in a rebound in Q2 [5][6] - The company anticipates revenue growth to continue in Q2 and accelerate in the second half of the year, particularly on the product side [32] Other Important Information - The company received approximately $1.1 million through Change Healthcare's temporary funding assistance program due to a cyber attack that affected billing processes [29][30] - The company also received over $400,000 in COVID relief funds from the treasury, contributing to nonrecurring income [31] Q&A Summary - No specific questions and answers were provided in the content, thus this section is not applicable.

Core Insights - VolitionRx Limited is focusing on commercializing its Nu.Q® platform in the human diagnostics market, with ongoing discussions with over ten companies, whose combined market value exceeds $600 billion [2] - The company aims to secure multiple licensing agreements in the human diagnostics space this year, similar to its strategy in the veterinary market [3] - Volition recorded its first revenue from sales of its CE-marked Nu.Q® NETs automated product in Europe in Q1 2025, marking a significant commercial milestone [4] Financial Highlights - Volition reported approximately $0.25 million in revenue for Q1 2025, a 44% increase compared to the same quarter in the previous year [8] - The net cash used in operating activities averaged $1.4 million per month, nearly 50% lower than in Q1 2024 [8] - The company received $4.3 million in funding during Q1 2025, with about $1.8 million from non-dilutive funding [8] - As of March 31, 2025, cash and cash equivalents totaled approximately $2.6 million, down from $3.3 million as of December 31, 2024 [8] - A convertible loan note was finalized post-quarter end, providing $6.25 million in gross proceeds, repayable over 24 months [8] - The goal for 2025 is to achieve cash neutrality, where income matches expenditure on a cash basis [8]

DUBLIN, May 15, 2025 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB) a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors, today announced results for the quarter ended December 31, 2024 and the fiscal year then ended. Key Highlights and Developments Management continues to make significant progress on the execution of the profitability focused initiatives announced in 2024 as part of its Comprehensive Transformation Pl ...

Company Overview - QuidelOrtho Corporation, based in San Diego, CA, specializes in in-vitro diagnostics technologies for point-of-care settings, clinical labs, and transfusion medicine, selling products directly to end users and distributors [11] Investment Ratings - QuidelOrtho is currently rated 3 (Hold) on the Zacks Rank, with a VGM Score of A, indicating a solid position in the market [12] - The company has a Growth Style Score of A, forecasting a year-over-year earnings growth of 27% for the current fiscal year [12] Earnings Estimates - Two analysts have revised their earnings estimates upwards in the last 60 days for fiscal 2025, with the Zacks Consensus Estimate increasing by $0.01 to $2.35 per share [12] - QuidelOrtho boasts an average earnings surprise of 70.8%, suggesting strong performance relative to expectations [12] Investment Potential - With a solid Zacks Rank and top-tier Growth and VGM Style Scores, QuidelOrtho is recommended for investors looking for growth opportunities [13]

Financial Data and Key Metrics Changes - The company reported a revenue of $800,000 for the last quarter, with a test volume of 3,034, which is at the upper end of the target range of 2,500 to 3,000 tests per quarter [9] - A significant balance sheet improvement was noted with a public offering netting $16,100,000, resulting in a pro forma cash position of $40,000,000 at the end of Q1, extending the runway well into 2026 [10] - The company achieved a large GAAP net income of $18,600,000 before non-controlling interest and preferred dividends, resulting in a positive primary EPS of $1.28 and a positive diluted EPS of $0.34 [22][23] Business Line Data and Key Metrics Changes - Lucid, the diagnostic subsidiary, is positioned to capitalize on a large clinical and market opportunity, with ongoing efforts to secure Medicare coverage [6][11] - Verus has restarted the development of a key implantable physiologic monitor, with favorable engagement from the FDA and a targeted filing for the first half of 2026 [12] - The incubator PMX is focusing on the PortIO implantable intraosseous device, with discussions ongoing with potential strategic partners [13] Market Data and Key Metrics Changes - The company is seeing momentum in new sales channels, particularly in concierge medicine and employer market contracts, which are expected to impact revenue in the second half of the year [10][11] - The company has a significant equity method investment balance of almost $47,000,000 reflecting a gain of $21,000,000 since year-end, representing an 82% increase in Lucid's stock price [18][19] Company Strategy and Development Direction - The company aims to diversify into the biopharma space, leveraging its infrastructure and management services model to pursue attractive biopharma assets [8][36] - The strategic vision includes expanding partnerships and exploring new opportunities while maintaining focus on existing subsidiaries like Lucid and Verus [53][54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning and ability to execute on strategic initiatives, highlighting the strong relationships with key cancer centers and the positive feedback from pilot programs [30][31] - The management team believes that the current market conditions will not hinder their ability to raise capital, citing successful recent financings [46][48] Other Important Information - The company has deconsolidated Lucid from its financial statements, which has impacted the historical understanding of its financials [16][21] - The company continues to explore additional assets and opportunities to diversify its portfolio, with a focus on maintaining operational independence among its subsidiaries [8][40] Q&A Session Summary Question: Feedback from the pilot program - Management received excellent feedback from the pilot program, meeting all pre-specified performance metrics and demonstrating clinical success [29][30] Question: Exclusive rights to the platform - There are no exclusive rights limiting broader commercialization; the agreement allows for a registry and initial implantable procedures at the cancer center [32][33] Question: Strategic rationale for biopharma expansion - The company is leveraging its infrastructure and management services to pursue biopharma opportunities, which align with its history of adapting to market needs [36][39] Question: Impact of market volatility on capital raising - Management indicated that market volatility has not affected their ability to raise capital, with successful recent financings demonstrating investor confidence [46][48]