About Us

Healgen Company Profile

Healgen is a leading global in-vitro diagnostics (IVD) developer and manufacturer, dedicated to advancing healthcare worldwide through high-quality, reliable, and innovative testing technologies. Founded in 2007 in Houston, Texas, Healgen has grown into a trusted name in diagnostics, serving healthcare providers and communities worldwide.​

Comprehensive Solutions Across Key Health Areas

Healgen offers a broad and diverse portfolio of diagnostic products designed to meet critical needs in both human and animal health. In human health, comprehensive solutions cover key areas such as infectious diseases including blood-borne, respiratory, sexually transmitted, tropical and vector-borne infections, cardiovascular health, fertility and women’s health, oncology, and toxicology. In animal health, Healgen provides specialized diagnostic solutions that support veterinary medicine and animal care, reinforcing the company’s commitment to comprehensive health across species.

Innovation at the Core

Continuous innovation drives Healgen forward. Healgen’s R&D teams develop advanced technologies that set new standards in diagnostic accuracy and efficiency, empowering healthcare professionals with precise, efficient, and actionable diagnostics. Our technology platforms include: Rapid Lateral-Flow (RLF) Testing, Fluorescent Immunoassay (FIA), Western Blot, Biochemistry, and cutting-edge Molecular Diagnostics such as Fluorescence In Situ Hybridization (FISH), Flow Cytometry, Loop-mediated Isothermal Amplification (LAMP), and Polymerase Chain Reaction (PCR). environment, fostering daily collaboration and teamwork.

Global Reach and Manufacturing Excellence

With an extensive network of 150+ partners and service centers spanning four continents, along with subsidiaries in the United States, Canada, and The United Kingdom, Healgen’s global presence ensures responsive service and timely delivery. Robust manufacturing infrastructure and rigorous quality systems guarantee consistent product excellence, supporting healthcare facilities worldwide.

Commitment to Better Health and Trusted Partnerships

At Healgen, patient well-being and customer satisfaction are at the heart of everything we do. We partner with healthcare professionals, research institutions, and distributors to deliver tailored solutions and comprehensive technical support wherever they are needed. Our mission is to enhance lives by making advanced diagnostics accessible and reliable for all. During the COVID-19 pandemic, Healgen played a vital global role by producing and distributing over 2 billion rapid antigen self-test kits, expanding access to reliable testing and supporting public health worldwide.​

Shaping the Future of Diagnostics

Healgen is committed to shaping the future of healthcare through relentless innovation, operational excellence, and a focus on quality. We continue to invest in research, talent, and technology to meet the evolving needs of global healthcare and to help safeguard the health of communities worldwide.

Key Milestones

Healgen Timeline

2007

Healgen established its first U.S. subsidiary in Houston, Texas.

2016

The first Canadian subsidiary, Healstone, was established in Vancouver, BC.

2018

Healgen received a Malaria Test Development Grant from the Gates Foundation.​

May 2020

Healgen granted a U.S. FDA Emergency Use Authorization (EUA) for its first COVID-19 Rapid Antibody Test.​

December 2022

Healgen’s global distribution of Rapid COVID-19 Antigen Self-Test kits surpassed 2 billion units across more than 80 countries, with over 400 million tests sold in the US alone.​

August 2023

Healgen Opened a state- of-the-art manufacturing and distribution facility in Houston, TX, with large-scale production capacity of 800,000 tests per day.​

May 2024

Healgen partnered with Project C.U.R.E. – the world’s largest distributor of donated medical supplies and equipment – to deliver critical medical equipment and supplies to underserved communities in over 135 countries worldwide.

June 2024

Healgen granted a U.S. FDA Emergency Use Authorization (EUA) for Healgen COVID-19/Flu A&B Rapid Antigen Test Cassette (Swab) Test.

October 2024

Healgen granted a U.S. FDA De Novo authorization for Healgen Rapid Check® COVID-19/Flu A&B Antigen Test - the first OTC combo Test authorized outside Emergency Use.

Healgen’s Rapid Check® COVID-19/Flu A&B Antigen Test named one of 2024’s Top 5 Medical Breakthroughs by the ABC News.

Our Mission and Vision

Our Mission

Enhance global health by delivering innovative, high-quality diagnostic solutions for both human and animal health. We are driven by the expertise and dedication of our people, the trust of our partners, and a commitment to making advanced diagnostics accessible and reliable for communities everywhere. Every product we create, every partnership we build, and every solution we deliver is in service of a healthier world.

Our Vision

Be the Genesis of Better Health—setting new standards in diagnostic science, empowering healthcare professionals, and improving lives across the globe. We strive to lead with integrity, foster innovation, and build lasting partnerships that shape the future of healthcare for all.​

Our Values

Integrity and Collaboration

At Healgen, our culture is built on a foundation of integrity, collaboration, and a shared commitment to advancing global health. We believe that the strength of our company lies in the dedication and expertise of our people, who work together to deliver innovative diagnostic solutions that make a meaningful difference in communities worldwide.​

Excellence and Innovation

We value excellence in everything we do—from research and development to manufacturing and customer support. Our teams are empowered to think creatively, challenge the status quo, and pursue continuous improvement, ensuring that we remain at the forefront of diagnostic technology.​

Trust and Transparency

Trust and transparency guide our relationships with customers, partners, and stakeholders. We listen, adapt, and respond to the evolving needs of the healthcare landscape, striving to build lasting partnerships based on respect and shared purpose.

Passion for Better Health

Above all, we are united by a passion for better health. Every decision we make is guided by our responsibility to patients, healthcare providers, and the broader community. At Healgen, we are driven not just by what we achieve, but by how we achieve it—upholding the highest standards of quality, ethics, and service in pursuit of a healthier world for all.​