Tangen Biosciences

Tangen Biosciences, Inc., established in 2013, operates within the molecular diagnostics market, focusing on the development of rapid, point-of-care diagnostic solutions. The company was co-founded by Dr. John Davidson and John Nobile, who brought extensive experience from their time at companies like 454 Life Sciences and Ion Torrent, where they were instrumental in developing next-generation DNA sequencing technologies. Dr. Davidson, with a Ph.D. in biochemistry from Harvard, has a background in developing DNA technologies, while Mr. Nobile has over 30 years of product development experience, particularly in DNA sequencer design. The firm is led by CEO Richard C. Birkmeyer, an experienced executive who joined in November 2018 after leading two other diagnostic startups to successful exits.

The company’s core offering is the TangenDx™ platform, a system designed to move molecular diagnostics from traditional laboratories into decentralized settings such as doctor's offices, pharmacies, and clinics. This platform consists of a portable, automated instrument called the GeneSpark™ and single-use disposable test discs. The technology employs isothermal nucleic acid amplification, which allows for the rapid and sensitive detection of targeted DNA and RNA directly from patient samples like nasopharyngeal swabs, whole blood, and sputum. A key feature is its ability to simultaneously detect a broad array of targets from a single sample, aiming to provide results in under an hour without requiring refrigerated reagents or extensive user training. This approach is designed to be faster, less expensive, and simpler than many existing commercial technologies.

Tangen Biosciences generates revenue through the sale of its GeneSpark™ instruments and the accompanying disposable assay cartridges. The business model targets healthcare providers who require timely diagnostic information to improve patient outcomes. The company has secured significant funding to support its operations, including a $9 million Series A round in 2019 and a $12.2 million Series B round in 2020. These funds were raised to scale up manufacturing and accelerate the clinical development of its infectious disease tests. Tangen has also received government contracts, such as one from the Biomedical Advanced Research and Development Authority (BARDA) to develop a rapid diagnostic test for anthrax and another for a SARS-CoV-2 assay. While its COVID-19 test received Emergency Use Authorization (EUA) from the FDA, this was later revoked in January 2024 at the company's request. The company has also been developing panel tests for various pathogens, including influenza A/B, RSV, sepsis-causing bacteria, and Candida auris.

Keywords: molecular diagnostics, point-of-care testing, infectious disease diagnostics, nucleic acid detection, isothermal amplification, GeneSpark, TangenDx, rapid diagnostics, decentralized testing, medical devices, diagnostic assays, pathogen detection, sepsis diagnostics, respiratory panel, antimicrobial resistance, virology, bacteriology, biodefense, CLIA-waived, diagnostic instruments