Everyone deserves but seldom receives world-class quality healthcare at the right time. If everything else checks, affordability might not always be in the picture. Identifying this massive gap in the healthcare system, Renegade.bio, an Asa CLIA, and CAP-accredited high-complexity laboratory, is building solutions to accelerate humanity’s capacity to test for infectious diseases in underserved communities. It is an LGBTQ-owned public benefit corporation. The company empowers an overburdened public health system to respond swiftly to epidemiologic crises by delivering fast, reliable, cost-effective solutions for community-based triage.

In collaboration with other laboratories, researchers, and organizations across the public health ecosystem, Renegade.bio is working towards making testing accessible to everyone regardless of income. Within Renegade.bio, there are two areas of focus that work in tandem to develop and distribute diagnostics to people successfully. Renegade Science and Renegade Reach. Renegade science develops and seeks out proactive solutions across the diagnostic space. It develops proprietary assays internally and with the biotechnology partners and deploys them through clinical laboratories.

Access is an issue for biotech companies seeking to bring their diagnostics to market. With complex regulatory pathways and laboratory licensing requirements—while useful and necessary—this prevents many novel diagnostics from ever making it to market. Communities suffer as a result. SOLUTION To solve this, renegade.bio partners with biotech companies to bring their technologies through the R&D stage and into clinics. By partnering with those that can deliver the technologies, we accelerate on-time diagnostics and the downstream benefits are seen in the direct benefits to human health— on-time diagnosis leads to on-time treatment. We also work within the biotechnology community of San Francisco, to support R&D assay development.

They have an in-house R&D team that develops novel diagnostics and assays that support drug development, leveraging capabilities and experience in biomarker discovery, PCR, NGS, and LCMS. They strive to make these diagnostics available on high-throughput platforms, which operate within the renegade network of laboratories. They manage assay validation, distribution, and back-end data collection for their partners. Also, their technology pipelines support diagnostic and therapeutic applications by providing the tools they need to create and implement novel assays. While Renegade Reach seeks out distribution channels for diagnostics, creating pathways through research and development, into the market, for the people who need them most. renegade.bio has developed a streamlined distribution process, aligning with local clinics, hospitals, and community groups to create clear channels for delivering affordable diagnostic technologies to people.

Renegade Reach is dedicated to bringing novel technologies to communities that will benefit the most from diagnostics improvements in the Hormones & Fertility Health and Infectious Disease spaces. Systemic inequalities like access, affordability, and communication barriers contribute to a more significant infection rate in many communities. Access is an issue for biotech companies seeking to market diagnostics. Complex regulatory pathways and laboratory licensing requirements, while valuable and necessary, prevent many novel diagnostics from ever making it to market. To solve this, Renegade.bio partners with biotech companies to bring their technologies through the R&D stage and into clinics. The downstream benefits are seen in the direct benefits to human health; on-time diagnosis leads to on-time treatment.

Recently, Renegade.bio announced that it has begun processing highly sensitive and accurate polymerase chain reaction (PCR) monkeypox tests for San Francisco and California, delivering test results in 24 hours through partnerships with surrounding clinics and hospitals. “Bringing critical diagnostics to our community is our core responsibility. They deliver cutting-edge science to the people that need it most,” says Renegade.bio CEO and Co-founder Craig Rouskey. “Early diagnosis of monkeypox is essential to interrupt disease transmission chains, provide earlier medical intervention, and protect public health,” he added.

Renegade.bio PrEP Testing provides regular, low-cost, and accessible STI testing to everyone to reduce HIV and STI-related health disparities and inequities. The company is in the process of developing a new PCR test panel for people on PrEP that will be able to detect a range of standard and not-so-common STIs. This test reduces the current barriers to STI testing, such as cost, time to results, and access, and will also provide better data with more than 45 STIs included, which could reduce annual PrEP testing costs. By accelerating the time to results, STI and PrEP testing will be more accessible and affordable.