Core Viewpoint - Oncocyte Corp. has published new data on its blood-based transplant rejection assay, indicating significant advancements in understanding organ rejection and potential market expansion opportunities for monitoring high-risk patients [1][4]. Scientific Significance - The study demonstrates a correlation between microvascular and vascular inflammation and elevated donor-derived cell-free DNA (dd-cfDNA) levels in blood plasma, enhancing the understanding of organ rejection biology [2]. - Two novel observations were made: T-cell mediated rejection (TCMR) is linked to high dd-cfDNA levels in the presence of vascular inflammation, while calcineurin inhibitor toxicity does not elevate dd-cfDNA levels [7][8]. Strategic Significance - The research supports the long-term management of high-risk transplant patients using Oncocyte's proprietary test, which is positioned to disrupt the market with more affordable and faster testing options [4][5]. - The study's findings validate the clinical utility of dd-cfDNA testing over a decade post-transplant, indicating its relevance in ongoing patient management [5]. - A significant portion of patients with organ rejection also exhibited de novo donor-specific antibodies, aligning with Oncocyte's previous clinical trial findings that led to expanded Medicare reimbursement [6]. Market Expansion - Oncocyte is developing a kitted version of its assay for local lab use, aiming to enhance accessibility and affordability of transplant monitoring tests [3]. - The collaboration with Charité University in Berlin has been instrumental in advancing scientific knowledge in transplantation, further solidifying Oncocyte's position in the market [4].

Core Insights - Mainz Biomed has entered into a technology partnership with EDX Medical Group to enhance cancer diagnostics in the UK [1][3] - The partnership will allow EDX Medical to utilize Mainz Biomed's molecular diagnostic technology, expanding its product offerings [2] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection [1] - The company's flagship product, ColoAlert, is a non-invasive test for colorectal cancer, currently marketed in Europe and undergoing FDA clinical studies for US approval [4] - Mainz Biomed's product pipeline includes PancAlert, an early-stage pancreatic cancer screening test [4] EDX Medical Group Overview - EDX Medical Group, based in the UK, develops digital diagnostic products for various diseases, including cancer [1][5] - The company aims to improve disease detection and treatment personalization through advanced biological and digital technologies [6]

SALT LAKE CITY, April 29, 2025 (GLOBE NEWSWIRE) -- Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today it will release its first quarter 2025 financial results on Thursday, May 8, 2025, after the market close. The Company will also host a conference call and webcast on the same day at 4:30 p.m. ET to discuss its financial results with analysts. Management on the call will include Dwight Egan, ...

Core Viewpoint - BioPorto A/S has issued 1,700,000 warrants to its Board of Directors as part of their remuneration, with each warrant allowing the purchase of one share at an exercise price of DKK 1.50, reflecting the current closing price on Nasdaq Copenhagen [1][2]. Summary by Sections Warrants Issuance - The issuance of warrants was approved during the annual general meeting on April 11, 2025, and is part of the company's compensation strategy for its Board members [1]. - The warrants will vest in equal tranches quarterly over a two-year period, with the first tranche becoming available at the start of the first calendar quarter following the grant date [3]. Terms and Conditions - The warrants are governed by the company's incentive warrant program and include provisions for claw-back in cases of erroneous financial information and accelerated vesting in the event of a takeover or business combination [4]. - The theoretical market value of the newly issued warrants is calculated to be DKK 1,843,580, based on the Black-Scholes formula, with an interest rate of 2.37% and historical volatility of 63.82% over 120 months [5]. Company Overview - BioPorto specializes in in vitro diagnostics, focusing on actionable biomarkers to enhance patient management and improve clinical outcomes [7]. - The company's flagship products utilize the NGAL biomarker to assist in the risk assessment and diagnosis of Acute Kidney Injury (AKI), enabling faster identification and intervention for at-risk patients [8]. - BioPorto operates facilities in Copenhagen, Denmark, and Boston, MA, USA, and is listed on the Nasdaq Copenhagen stock exchange [9].

Core Business Growth - Eurobio Scientific reported a revenue increase of 19% to €154.2 million in 2024, compared to €130 million in 2023, with organic growth at 9% [4][5][6] - Proprietary products accounted for 31% of total sales, remaining stable compared to the previous year, while international sales represented 41% of group revenue, up from 38% in 2023 [5][6] Financial Performance - Total operating income rose by 19% to €154.9 million, with a gross margin of 46.6%, down approximately 1% from 2023 due to pressure on margins and challenges faced by some European subsidiaries [4][7] - Adjusted EBITDA was €27.7 million, a slight increase from €27.3 million in 2023, while operating income was stable at €22.1 million [10][11] Cost Management - Research and development expenses decreased to €4.6 million, primarily due to reduced activity in France, while marketing and sales expenses increased by €10.1 million, driven by strengthening sales teams and new acquisitions [8] - General and administrative expenses rose by €1.8 million, attributed to new premises and acquisitions [8] Strategic Developments - The company completed the acquisition of EndoPredict® and Prolaris® in August 2024, generating sales of €3.8 million, although this was a 10% decline compared to 2023 [9] - Eurobio Scientific is focused on strategic priorities including the development of proprietary products, internationalization, and market expansion to enhance growth in sales and margins [16] Cash Flow and Debt Management - Free cash flow for 2024 was €6 million, with cash flow from operations amounting to €16.7 million [12][13] - At the end of December 2024, the company had cash and cash equivalents of €23.1 million and net debt of €3.9 million [15]

Core Viewpoint - BioPorto A/S is set to present its financial results for Q1 2025 during a webcast on May 8, 2025, highlighting its focus on early detection of Acute Kidney Injury (AKI) [1] Company Overview - BioPorto A/S specializes in in vitro diagnostics aimed at improving early detection of AKI, utilizing actionable biomarkers to enhance patient management [2][3] - The company leverages its expertise in antibodies and assay development to create innovative products addressing significant unmet medical needs [2] Product Information - The flagship products of BioPorto are based on the NGAL biomarker, which aids in the risk assessment and diagnosis of AKI, a condition that can lead to severe health consequences if not treated promptly [3] - NGAL tests allow for quicker identification of patients at risk of AKI compared to standard care measurements, facilitating earlier interventions and tailored management strategies [3] Company Facilities and Stock Information - BioPorto operates facilities in Copenhagen, Denmark, and Boston, MA, USA, and is listed on the Nasdaq Copenhagen stock exchange [4]

Core Insights - Mainz Biomed N.V. is focused on molecular genetics diagnostics for early cancer detection and is progressing towards FDA premarket approval for its products [1][4] Company Developments - The company reported significant progress in Q1 2025, driven by strong clinical results from three studies published in 2024 [1] - The eAArly DETECT 2 study has commenced, evaluating a next-generation colorectal cancer test with results expected by the end of 2025 [4] - Mainz Biomed has signed a license agreement with Liquid Biosciences to access novel mRNA biomarkers for early pancreatic cancer detection, achieving 95% sensitivity and 98% specificity in independent validation [4] - A strategic partnership with labor team w ag has been established to introduce the ColoAlert CRC screening test to the Swiss market, addressing the urgent need for early detection in Switzerland [4] - The enhanced ColoAlert CRC screening test has been launched in Germany, coinciding with Colorectal Cancer Awareness Month in March 2025 [4] Regulatory Compliance - Mainz Biomed has regained compliance with Nasdaq's minimum stockholders' equity requirement and the minimum bid price requirement, ensuring full compliance with all Nasdaq continued listing requirements [4]

Core Insights - AccuStem Sciences, Inc. and EmeritusDX are expanding their strategic partnership to commercialize the MSC test for lung cancer screening, aiming to improve accuracy in lung nodule stratification and reduce healthcare costs [1][3] - The MSC test analyzes 24 microRNAs to differentiate between high- and low-risk lung nodules, facilitating earlier patient care and potentially minimizing unnecessary procedures [2] - The operational deployment of the MSC test is planned for launch in US clinics in 2026, with both companies pursuing reimbursement strategies to enhance access for the 1.6 million patients diagnosed annually with lung nodules in the US [3] Company Overview - AccuStem is focused on optimizing outcomes and quality of life for cancer patients through proprietary molecular testing that addresses unmet clinical needs from screening to treatment [5] - EmeritusDX specializes in delivering actionable clinical information and operates a world-class laboratory that supports cancer diagnosis and treatment [7] Leadership Statements - Wendy Blosser, CEO of AccuStem, emphasized the significance of the MSC test in lung cancer screening technology and the potential for impactful diagnostic solutions [4] - Robert Embree, CEO of EmeritusDX, expressed excitement about the collaboration and the commitment to expanding access to innovative diagnostics for cancer patients [4]

Castle Biosciences celebrates an incredible milestone — the 200,000th order of the DecisionDx-Melanoma test! This milestone is so much more than a number: it represents 200,000 opportunities to provide clinicians and their patients with more accurate, more personalized insights that help guide their treatment plan decisions in melanoma care. With every test, we're empowering health care professionals to make more informed and more precise decisions that can fundamentally transform lives.Castle founder, pres ...

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 ...