A Delaware company could play a key role in the unprecedented COVID-19 testing regime experts say is required for the country to reopen – and stay open – safely after a two-month lockdown.
Wilmington-based LabWare’s innovative system for rapidly capturing and communicating COVID test results may just be the essential element that makes effective testing at scale a real, near-term possibility.
The company sees multiple applications for their portable testing kit – from major employers, to airlines, casinos, schools and universities, and departments of health.
LabWare system: eliminates paperwork, results in minutes
The global leader in enterprise software testing – 80 percent of all clinical trials utilize their laboratory information management systems (LIMS) – LabWare has developed a mobile, cloud-based system that reduces the need for cumbersome, and often mistake-prone paperwork.
LabWare’s field collection kit will also enable rapid communication of testing results to individuals as well as public health labs anywhere across the country, including the US Centers for Disease Control and Prevention (CDC).
This step change in data collection and sharing could transform both the effectiveness and strategic deployment of testing while giving health officials critical, timely information to help contain spread of the disease.
LabWare CEO Vance Kershner says their barcode-based system simplifies and standardizes a process characterized by “a tidal wave of paper.”
“The thing that only we can do is label a sample in a way that connects that sample with a patient with a wireless barcode printer,” said Kershner. “Otherwise they would handwrite a person’s name and date of birth – the key thing is that only we [LabWare] can get a properly labeled specimen tied to the order and information management systems so that nothing gets lost or is misidentified.”
With state orders, production is ramping up
The state of Florida has already done a trial run with the LabWare system in two counties and now has plans to take their kit statewide. The state has ordered 150 units, one for each of their 67 counties with additional units for the larger ones.
Referring to the Florida Department of Health’s pilot program using LabWare, Kershner says the portability and ease of use – anyone can be trained to use the testing kit – has increased testing efficiency in that state.
“Not everybody comes to them. So they have to go out to assisted living facilities, and Florida has quite a number of these. They needed to assign a team of people to go accomplish it — these nurse teams would go out in the fields, which takes hours to schedule and execute. So we very rapidly added in some basic scheduling capabilities for them, and what they found [when using the LabWare devices] was that the scheduling nurse productivity went up by 100 percent,” said Kershner.
LabWare says Delaware has ordered three of the self sustained units. The Delaware Emergency Management Agency (DEMA) would not elaborate on their plans to deploy the devices other than to say “discussions are ongoing” with LabWare and other COVID testing system providers.
LabWare’s technology uses an app on an iPad to connect via mobile hotspot into the company’s LIMS, which sits on a secure, HIPPA-compliant cloud-based server.
The LabWare system can do everything from facilitate the scheduling of visits at testing locations to quickly and easily capturing patient demographic information while transmitting information to local departments of health within minutes. There’s no pen and paper, or clipboards involved – a reduction in paperwork that can significantly reduce the risk of errors through what is now a clunky, multi-step process.
The electronic scanning of ID’s and digital capture of information also speeds up the testing process itself.
“The iPad will scan the driver’s license and pull all the demographics off the back of the driver’s license. We then ask for a phone number and an email address, and then a list of triage questions that can be customized by customer – by state, by county, whatever their requirements are,” says LabWare’s special operations director Vaughn Hardin.
And the versatility of LabWare’s cloud-based system will extend and improve the effectiveness of point-of-care testing, well beyond what to date has largely been focused around central sites with limited hours and days of wait time for results, inconvenient impediments that can deter patients from getting tested.
Partnership with Tangen
LabWare is partnering with Connecticut-based Tangen Biosciences on a testing cartridge that could significantly enhance early detection of the virus as well as screen for up to five diseases at once. Each rapid Tangen test costs $60.
“Tangen’s GeneSpark cartridge has the ability to be loaded with reagents for all of those major viruses, including influenza A and B, for COVID-19, four SARS for MRSA infections. This will be critical in the fall when we’re not only dealing with the resurgence of COVID-19 that all the experts say is going to happen, but we’ve also got influenzas,” said Hardin.
Tangen’s GeneSpark system uses RNA tests via a handheld instrument that captures nasopharyngeal samples (nasal or back of throat swabs) and can turn around results in seven to 30 minutes. Medical grade swabs do not come with the LabWare kit.
Their point-of-care molecular diagnostic assay for COVID-19 is funded with a $700,000 contract with the Biomedical Advance Research and Development Authority (BARDA) and awaits FDA approval.
Hardin says their technology can drive rapid collection and sharing of data as testing expands into workplaces, event venues and other areas businesses and public health officials would want to target as the economy comes back to life.
“The point of care analyzer from Tangen would make this kit completely self-contained. So you could set it up at a major employer like Citibank or Chase or one of the casinos, and as employees or guests are coming in, you could test them, then set them aside for anywhere from seven to thirty minutes, while the analyzer is testing the cartridge. And you can tell them [the results] right away,” said Hardin.
Some Silicon Valley tech and software companies are exploring collaborations with pharmaceutical companies to introduce testing apps on mobile devices with similar functionalities, but thus far the technology is unproven and is not expected to be available until the end of 2020.
LabWare production will be in Delaware
Meanwhile, after the successful pilot in Florida, LabWare has begun production of kits here in Wilmington by an initial team of twelve. As the company ramps up full-scale production next week, they say the expanded production will stay here in Delaware.
The software brains of the LabWare system can be used with any testing device or application, be it COVID-19, SARs or seasonal influenza. In addition to the pairing with the GeneSpark instrument (which uses nasal or back-of-throat swab), LabWare’s kit can be deployed with any kind of sampling instrument. The wifi hotspot that enables the encrypted communication network is password protected and available in 160 countries, a potential game-changer for capturing and analyzing test results from remote hotspots around the globe.
The LabWare software kit itself costs $15,000; sold together with the GeneSpark point of care testing instrument the price is $20,000. Each Tangen GeneSpark test costs $60, and the swab tests would have to be purchased separately.
Kershner expects that demand will soon grow quickly.
“We’re putting a big focus on ramping up the ability to put these kits out there and secure the supply chain, building the internal systems needed to support the levels of production we foresee coming.”