Access Bio
Leading the Battle Against Infectious Diseases

In society, every life holds equal value, regardless of race, ethnicity, or religion. This belief forms the core philosophy of Access Bio, embodying the principles of "Access to LIFE" and "Bio for HOPE." This philosophy has shaped Access Bio’s mission to prevent and diagnose often-neglected infectious diseases like malaria and dengue. Two decades after its founding, the company remains dedicated to improving global health, especially for underserved populations. Driven by global needs and the potential for positive impact, Access Bio collaborates with partners worldwide to make a meaningful difference in healthcare.

“Many diagnostic companies encounter challenges in developing and manufacturing their products, and we are well-equipped to help these companies with our cutting-edge R&D capabilities and expertise in the manufacturing of in vitro rapid diagnostic tests, biosensors, and molecular diagnostics,” says Young Ho Choi, chairman and CEO of Access Bio.

Leading the Charge Against the Global Emergency

In 2020, as the pandemic unfolded, Access Bio was one of the first diagnostic companies to take swift action. This proactive response led to four of its products receiving Emergency Use Authorization from the U.S. FDA. Through federal and state programs, Access Bio has delivered over 300 million COVID-19 tests across the U.S., playing a crucial role in the nation’s efforts to combat the pandemic.

With the opening of its second manufacturing site in Monroe, NJ, Access Bio has increased its annual testing capacity to 300 million, positioning itself as one of the leading manufacturers of rapid diagnostic tests in the U.S. This expansion strengthens Access Bio's ability to deliver timely and accessible testing solutions, which is crucial for effective public health responses, particularly during outbreaks or health emergencies.

Overcoming the Limitations of Rapid Diagnostic Tests (RDT)

Mr. Choi envisioned overcoming the limitations of traditional rapid diagnostic tests (RDTs) by achieving sensitivity comparable to molecular diagnostics (MDx) at a fraction of the cost. Designed for ease of use in field settings with minimal training, this innovation expands accessibility and enhances effectiveness across various environments.

Today, the company is excited to announce the launch of CareSuperb™, Access Bio’s next-generation cutting-edge platform that drastically improves sensitivity. This improvement has been substantiated by results from an extensive evaluation study using clinical samples.

The performance comparison with leading molecular diagnostic products demonstrated an agreement rate of over 95% for positive samples, underscoring the reliability and accuracy of the CareSuperb™ platform in clinical settings. Additionally, internal comparative evaluations against leading RDTs have demonstrated CareSuperb™'s unparalleled performance, confirming its ability to detect analytes at concentrations up to 64 times lower. This breakthrough marks a major step forward in detecting infectious diseases with superb accuracy and reliability, enabling earlier and more precise diagnoses.

A Comprehensive, Innovative Approach to Infectious Diseases

Access Bio’s strategy for preventing and diagnosing infectious diseases is rooted in a comprehensive and innovative approach that emphasizes research, advanced diagnostic solutions, global accessibility, and a commitment to quality.

1. Innovative Research and Development:

At the heart of Access Bio's mission is its advanced R&D program, focused on pioneering diagnostic technologies. The company continuously develops rapid tests, biosensors, and molecular diagnostics that ensure high accuracy in detecting infectious diseases. A prime example of this is the CareSuperb™ platform.
2. Comprehensive Diagnostic Solutions:

Access Bio’s patented platform, CareSuperb™, is designed for the early and multiple detection of various diseases, including blood disorders, cardiac markers, and metabolic conditions. This innovative technology is crucial for timely treatment and intervention. Furthermore, the company is actively engaged in digital diagnostics, integrating AI and electrocardiograms into its solutions to address the evolving needs of healthcare.

3. Global Outreach and Accessibility:

Accessibility is central to the company’s strategy. Access Bio ensures that its diagnostic tools reach underserved and vulnerable populations, particularly in regions where infectious diseases are most prevalent. Through its global distribution network and partnerships with international organizations, the company contributes to public health efforts worldwide.

4. Commitment to Quality and Reliability:

From research and product development to manufacturing and distribution, Access Bio follows strict quality control processes to guarantee its diagnostics meet the highest standards. This commitment ensures that healthcare professionals have the reliable tools they need for effective prevention and diagnosis.

Through these efforts, Access Bio remains dedicated to improving global health by enhancing the prevention and early detection of infectious diseases.