Maxim Biotech

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Overview

Maxim Biotech, also known as Maxim Biomedical, Inc., is a Maryland-based biotechnology company specializing in the development and manufacturing of in vitro diagnostic devices. Founded in 2005, its mission is to provide affordable and accessible diagnostic solutions to improve patient outcomes globally. Headquartered in Rockville, Maryland, the company is renowned for its innovative lateral flow and diagnostic devices. Maxim Biomedical has made significant strides in partnerships with major healthcare companies and government agencies for developing products critical in wellness, biodefense, and other health sectors.

Recent Developments

  • March 2025: Maxim Biomedical received a follow-on award from the National Institutes of Health (NIH) through the Rapid Acceleration of Diagnostics (RADx®) initiative, reinforcing its role in advancing home-based diagnostic technologies.
  • January 2024: The company announced a significant $49.5 million manufacturing award from the U.S. Department of Health and Human Services (HHS) to bolster pandemic testing efforts, highlighting the company's contribution to public health resilience.
  • October 2023: The FDA extended the shelf-life of MaximBio’s ClearDetect™ COVID-19 Antigen Home Test, allowing for longer usability of the product.
  • May 2023: Maxim Biomedical secured a new agreement for a rapid diagnostic platform with the NIH, demonstrating continued innovation and public health collaboration.
  • February 2023: MaximBio expanded its manufacturing capabilities to increase production of lateral flow and diagnostic devices, reflecting its commitment to meeting increasing healthcare demands.

Company Information

AttributeInformation
Founding Date2005
HeadquartersRockville, MD, USA
FoundersJoe Ma
RevenueNot publicly disclosed
ProfitsNot publicly disclosed
Key InvestorsCTM Investments, NIH, U.S. HHS
IndustryBiotechnology, Medical Devices
Number of EmployeesApproximately 25

Early History

Maxim Biotech was established to address the growing needs for precise, effective diagnostic tools and solutions. Initially focusing on providing innovative in vitro diagnostic tools, Maxim Bio quickly developed expertise in lateral flow assay technology, which became the foundation for its future offerings. The company's early years were marked by strategic partnerships that enabled it to expand its technology into multiple healthcare applications, including infectious diseases and women’s health.

Company Profile and Achievements

Maxim Biomedical operates with a clear focus on enhancing healthcare diagnostics through cutting-edge technology. Its business model revolves around providing turnkey development and manufacturing services for lateral flow and other diagnostic devices.

  • Innovations in diagnostic assays for wellness, biodefense, and infectious diseases have established Maxim Bio as a reliable name in the biotechnology sector.
  • Strategic partnerships, including with the U.S. Department of Health and Human Services, have been pivotal in securing funding and support for product development.
  • FDA approvals and adherence to international quality standards such as ISO 13485 confirm the company's compliance with the highest industry benchmarks.
  • Significant growth in product manufacturing capabilities, particularly in response to the COVID-19 pandemic, underscores Maxim Bio’s responsiveness and agility in addressing global health crises.

Current Operations and Market Position

Currently, Maxim Biomedical focuses on the manufacture and distribution of medical diagnostic devices with specific expertise in lateral flow assays. The company is engaged in multiple sectors, ranging from public health to biodefense, reflecting its broad scope and capability. With a robust quality management system, Maxim Bio ensures high standards of production, meeting both current U.S. FDA regulations and international quality certifications. The company's market position is reinforced by continuous innovation and expanding production capabilities to meet global demands.

Conclusion

Maxim Biotech is a pivotal company in the field of medical diagnostics, recognized for its comprehensive approach to health technology development. Its emphasis on creating accessible, high-quality diagnostic tools positions it as a leader in the biotechnology sector. Looking ahead, Maxim Biomedical is poised for further growth and innovation, driven by ongoing partnerships and a commitment to advancing public health solutions globally. With strategic investments and expansions, the company is set to continue its influence on improving diagnostics and healthcare outcomes worldwide.

References

  1. Maxim Biomedical Official Website
  2. National Institutes of Health - RADx Initiative
  3. FDA Clearance Announcements