December 18, 2024 – Milpitas, CA – IGeneX, a leader in innovative diagnostic solutions for tick-borne diseases, proudly announces its significant contribution to the U.S. Department of Health and Human Services (HHS) as part of the NOIS2-192 project. This effort, aimed at advancing Lyme disease diagnostics, underscores IGeneX’s commitment to supporting public health initiatives and ensuring access to high-quality diagnostic tools.
As part of the NOIS2-192 project, IGeneX provided an extensive regulatory document prepared in alignment with the FDA’s 510(k) submission process for in vitro diagnostic (IVD) devices. The document, developed using the FDA’s eSTAR (electronic Submission Template and Resource) format, serves as a comprehensive framework for ensuring compliance with stringent regulatory requirements. It includes detailed device descriptions, labeling, performance testing summaries, and data validation methodologies.
“IGeneX is dedicated to advancing Lyme disease diagnostics through rigorous scientific research and regulatory compliance,” said Dr. Jyotsna Shah, PhD, President and Laboratory Director at IGeneX. “By contributing this document to the HHS initiative, we are helping to streamline the regulatory process and ensure that innovative diagnostic tools meet the highest standards of accuracy and reliability.”
The provided document delivers critical value to the NOIS2-192 project, including:
• Regulatory Alignment: Offers a structured approach to meeting FDA requirements for Lyme disease diagnostics.
• Data Validation: Includes methodologies for assessing device performance characteristics, such as specificity, reproducibility, and stability.
• Streamlined Submissions: Serves as a template for efficient and compliant 510(k) submissions.
• Collaborative Framework: Enhances stakeholder collaboration by providing a robust regulatory roadmap.
IGeneX’s contribution highlights its leadership in Lyme disease diagnostics and its unwavering commitment to supporting HHS’s goal to combat tick-borne diseases. This effort aligns with IGeneX’s broader vision of empowering healthcare providers and patients with reliable, cutting-edge diagnostic tools.
For more information about IGeneX’s innovations and contributions to Lyme disease diagnostics, visit www.IGeneX.com.
About IGeneX, Inc. IGeneX, Inc. is a leading provider of advanced diagnostic testing for tick-borne diseases, including Lyme disease, Babesiosis, and Bartonellosis. With over 30 years of experience, IGeneX is committed to delivering accurate, timely, and comprehensive testing solutions to support patient care and advance public health initiatives.
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