An analytical technique developed at Lawrence Livermore National Laboratory (LLNL) to combat bioterrorism is also a powerful weapon in the fight against COVID-19. The technology’s capacity for early detection, whether used for biosecurity or for pandemic response, can be the difference between life and death. 

A team of LLNL researchers developed the Digital Droplet™ Polymerase Chain Reaction (ddPCR) technology as an anti-bioterrorism detector to meet the laboratory’s strategic mission in national biosecurity. 

Polymerase chain reaction (PCR) is a well-established technology for molecular and genetic analysis that allows scientists to amplify a small amount of DNA in a sample for detailed study. Unlike other conventional PCR techniques, the ddPCR approach allows partitioning of each sample into tens of thousands of droplets, each of which can be independently amplified. 

Simply put, ddPCR enables thousands of data points from a single sample, which leads to higher precision, accuracy and sensitivity. Other advantages include cost-effectiveness, ease of use and integration into clinical research and life science workflows, increased signal-to-noise ratio and simplified quantification.

LLNL’s ddPCR technique was patented and licensed co-exclusively to start-up QuantaLife Inc. and RainDance Technologies Inc. Additional licenses were executed with Bio-Rad Laboratories when that company acquired QuantaLife and then RainDance. In February 2019, Bio-Rad received Food and Drug Administration (FDA) approval for a liquid-biopsy test kit, featuring ddPCR technology, for early detection of chronic myeloid leukemia.

Licensing the ddPCR technology has enabled ddPCR’s commercial use by international researchers and medical professionals to delve deeper into a wide range of genetic mysteries, from sequential mutations and cancer progressions to pathogen adaptations and personalized treatments based on a patient’s unique genetic needs. Research published in more than 5,100 studies has drawn on ddPCR technology to pave the path to scientific breakthroughs. 

Simply put, ddPCR enables thousands of data points from a single sample, which leads to higher precision, accuracy and sensitivity.

In May 2020, Bio-Rad’s SARS-CoV-2 ddPCR test kit received emergency use authorization from the FDA for COVID-19 applications. The test’s high degree of sensitivity makes it more effective than other PCR tests for identifying individuals in the early stages of infection and for detecting minimal residual disease in people recovering from COVID-19. The ddPCR technology will continue to transform medicine and promises to prompt innumerable discoveries within diagnostics and beyond. 

The commercialization of ddPCR has had a regional economic impact as well. When co-inventor Bill Colston founded QuantaLife, he shared his entrepreneurial experience with a number of other LLNL researchers who became QuantaLife employees. Many former QuantaLife employees went on to establish their own, equally successful, companies with significant impact to life science research and the health care market. Supported by the success of QuantaLife and the ddPCR technology, Bill Colston went on to found HealthTell, RubrYc Therapeutics, iCarbonX and an R&D incubator, Sestina Bio.