Core Insights - BioMark Diagnostics has established a strategic partnership with SAMA CONSULTING to explore the clinical application of its liquid biopsy technology for lung cancer detection in Tunisia and North Africa, targeting a population of over 90 million [1][5][6] - The collaboration aims to address the urgent need for innovative early detection solutions for lung cancer, which is a leading cause of cancer-related mortality in Tunisia [2][5] - A proof-of-concept trial is set to begin in October 2025 to evaluate the performance and clinical utility of BioMark's technology within the Tunisian healthcare system [3][7] Strategic Expansion - This partnership marks BioMark's entry into the North African market, demonstrating its commitment to expanding access to advanced cancer diagnostics in emerging healthcare markets [4][6] - The collaboration leverages SAMA CONSULTING's local expertise to facilitate rapid implementation and regulatory compliance [4][9] Clinical Objectives - Key objectives include assessing the technology's effectiveness in the target population, advancing the publication of clinical data to support broader adoption, and evaluating integration potential with national screening programs [5][6] Regulatory Compliance - Both organizations are committed to ensuring compliance with Tunisian healthcare regulations and international clinical trial standards, operating under comprehensive Non-Disclosure Agreements to protect proprietary information [8][9] Company Background - BioMark Diagnostics is a leading developer of liquid biopsy tests for early cancer detection, utilizing metabolomics and machine learning algorithms to enable earlier diagnosis and improved patient outcomes [10] - SAMA CONSULTING SARL specializes in healthcare innovation and clinical research facilitation, providing expertise in regulatory compliance and clinical trial management across North Africa and Francophone Africa [9]

Core Points - BD has received FDA 510(k) clearance for the BD Veritor™ System for SARS-CoV-2, a digital test for detecting COVID-19 antigens in symptomatic individuals within approximately 15 minutes [1][2] - The BD Veritor™ System has been available under Emergency Use Authorization since September 2020, and the new clearance will replace the EUA version starting in early fall 2025 [3] - The system is designed for use in CLIA-waived environments and provides results from nasal swab specimens within six days of symptom onset, enhancing timely clinical decision-making [4] Company Overview - BD is one of the largest global medical technology companies, focusing on improving medical discovery, diagnostics, and care delivery [6] - The company employs over 70,000 individuals and is committed to enhancing the safety and efficiency of healthcare delivery processes [6] - BD collaborates with organizations worldwide to address significant global health challenges, aiming to improve outcomes, lower costs, and expand healthcare access [6]