QX200 Droplet Digital PCR

Used by researchers around the world, Bio-Rad's QX200 Droplet Digital PCR (ddPCR) System quantifies target DNA or RNA molecules. The company’s SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit is run on the QX200.

Bay Area companies are using technology with direct ties to Lawrence Livermore National Laboratory to aid the country’s efforts to combat the virus that causes COVID-19.

Last month, Bio-Rad became the second Bay Area company to gain emergency approval from the FDA for diagnostic tests to detect the presence of the coronavirus. The test is based on a technology that was licensed from LLNL.

In March, Cepheid Inc., another LLNL licensee, secured FDA’s go-ahead for its rapid test. It landed the first emergency authorization for a COVID-19 test that could provide results outside of a laboratory setting.

In the meantime, the Lab is using money from royalties and licensing of its technology to push forward with new COVID-related research and development, including the development of a mechanical ventilator prototype.

“Partnerships are integral to much of what we do at LLNL. This reality is especially driven home when there is a crunch, when there’s a crying need for a science solution to a problem,” said Rich Rankin, director of the Lab’s Innovation and Partnerships Office.

“We conduct long-term research for solutions to national problems, year in and year out, but LLNL shines when there’s a critical need for solutions to important challenges. That’s something within the DNA of the Laboratory,” Rankin said.

COVID-19 Test Kits Using LLNL Tech

Regular, accurate testing of COVID-19 is a key component in the fight against the global pandemic, according to the World Health Organization.

Bio-Rad, based in Hercules, gained approval for its Droplet Digital PCR test kit which runs on the company’s QX200 and QXDx ddPCR systems. That test is based on a technology that was licensed from LLNL more than 10 years ago.

The high sensitivity of the test makes it well suited to screening upper respiratory samples in patients with a low viral load, including individuals in the early stages of infection, as compared to other types of tests, according to the company.

The test can also play an important role in surveillance by detecting minimal residual disease in people recovering from COVID-19, informing them if they are negative for the virus.

Cepheid Inc., of Sunnyvale is the other LLNL licensee that has received an emergency use authorization from the FDA for coronavirus diagnostic tests. It licensed an LLNL technology called rapid PCR thermocycling, integrating amplification and detection.

Co-founded in 1996 by former LLNL researcher Allen Northrup, Cepheid created detection technology that was used after the 2001 anthrax attacks to screen mail for anthrax. It also has been deployed for the detection of Ebola.

Lab Working on Mechanical Ventilator Prototype, New Diagnostics

Meanwhile, according to the Lab, it has spent more than $1 million of licensing and royalty money, produced by Lab licenses, to fund the development of a mechanical ventilator and research on other COVID-19-related technologies.

Funds are received from the licensing of technologies developed by LLNL scientists and engineers to companies that create commercial products. The companies then pay LLNL royalties when products are sold.

The LLNL mechanical ventilator’s design is derived from proven concepts and contains parts that are not being used by commercial ventilator manufacturers, to avoid disrupting already thin supply chains.

The ventilator, branded as SuppleVent, has received an emergency use authorization from the FDA and is part of a cooperative research and development agreement with BioMedInnovations LLC.

Another project in development at the Lab is a diagnostic tool.

LLNL biomedical researcher Larry Dugan is seeking to develop a highly-sensitive, non-invasive, rapid and simple to use one-tube sample-to-result diagnostic kit to detect COVID-19 in oral and nasal samples in less than an hour.

The Lab is also granting royalty-free, non-exclusive licenses for LLNL technologies that could be used against the pandemic.

“The thought behind it is to help companies to evaluate a new technology for addressing an aspect of COVID-19 at a lower risk,” Rankin said. “As the crisis passes, the company can come and look at possible longer-term licenses.”