WILMINGTON – LabWare, the leading global provider of enterprise software for testing laboratories, has created a COVID-19 test kit that will help states and hospitals eliminate the paperwork at collection sites, reduce the turnaround for test results, and streamline distribution of the results.    [caption id="attachment_198629" align="alignleft" width="300"] LabWare Founder Vance Kershner[/caption] The company, which was founded in 1987 by Vance Kershner, is working with a Connecticut company called Tangen Biosciences to build on the strengths of LabWare’s new field collection kit. Within the next few months, they will roll out a portable laboratory that will reduce the wait time for results to just minutes, aiding efforts to stem the spread of the virus.  “Everyone is talking about the need for testing,” Kershner said. “But very few people are talking about data collection and the lack of interface nationally.”   This type of coordination around data is especially important as many states consider relaxing social distancing restrictions.   “Timely and complete surveillance data is key to controlling further spread of COVID-19 and quickly tamping down any clusters to prevent a full-blown second wave of infections as people begin to travel more,” said Jennifer Horney, professor of epidemiology at the University of Delaware.  In other words, this solves a key underlying problem: Viruses don’t stop at state borders but right now, data does. It also reduces the paperwork challenges tied to explosive growth in COVID-19 testing.  [caption id="attachment_198645" align="alignright" width="400"] The LabWare-Tangen portable laboratory[/caption] Implementing the LabWare kit and the Tangen GeneSpark instrument could help public health departments monitor the spread of the disease and decrease the number of infections in their communities. In addition, states like New York needing to process a high volume of tests will be able to send them to less busy places across the United States and get their results back within three days with copies to the U.S. Centers for Disease Control and Prevention and state health organizations done electronically as soon as results are completed. LabWare’s solution can be used independently with any testing system, enabling it to be utilized nationwide, or even globally.  “After 9/11 happened, there was a concern about bioterrorism, so the federal government gave money to each state to put in a good information management system for public health. But they didn’t require them all to use the same system,” Kershner said, explaining that Florida, Delaware, Texas, Oklahoma, South Dakota, New Mexico, and Utah chose LabWare and will get first crack at the new test kits.  “Every single person who sees what we have thinks it’s useful, particularly for surveillance work,” he said. “We know that all 50 states have these issues. Our focus right now is on testing. We thought the hard part would be building this thing. The hard part is communicating that we have it, but Florida will be hosting a conference call with our LabWare customers and getting the word out to the states that are in triage mode and need back-end data management.” 

How BARDA Fits In

The linchpin in the entire effort is the Biomedical Advanced Research and Development Authority (BARDA), which is a U.S. Department of Health and Human Services office responsible for procurement and development of countermeasures principally against bioterrorism, but also including chemical, nuclear, and radiological threats as well as pandemic influenza and emerging diseases.   BARDA is Tangen’s sole source of revenue and recently awarded the company a contract to develop a rapid diagnostic test for use on the Tangen GeneSpark handheld molecular diagnostic system to detect the SARS-CoV-2 virus that causes COVID-19. Turnaround time from sample collection to result is approximately one hour per sample. Results are provided to users and integrated into a cloud-based mobile platform that can convey anonymous test results to public health agencies.   Kershner has self-funded the first 200 kits in production and the company is actively seeking funding sources to scale up to 1,000 kits. He believes LabWare can quickly ramp up to produce 2,500 to 4,000 kits per month.  LabWare is ready to start assembling the kits in a facility on the Wilmington Riverfront. Special Operations Director Vaughn Hardin said production will launch with 12 people, all college students who will have difficulty finding jobs in the current economic climate, staffing the shipping and receiving, inventory, configuration and assembly positions.  Today, most COVID-19 test results arrive in two to four days from commercial labs, such as LabCorp or Quest Diagnostics. With the Tangen instrument, the results will be ready in 20 minutes and can be communicated to the patient while they wait, so infected patients can immediately self-quarantine to reduce the risk of spreading the virus.  [caption id="attachment_198630" align="alignleft" width="300"] Rick Birkmeyer of Tangen Biosciences[/caption]

Adding Tangen Into the Mix

Tangen’s CEO is Rick Birkmeyer, who founded Claymont-based CD Diagnostics and is a general partner for Delaware’s Leading Edge Ventures with Kershner, Mike Bowman, Jeff Davison, and Doug Petillo.   “Molecular tests will tell you if you’re carrying the virus right now – that you’re either a carrier or you’re going to get the disease or you have the disease,” Birkmeyer said. “We’ll be able to tell people immediately to go home – unless they’re having breathing problems – and stay isolated.”  Tangen is one of the few companies that has been working on a handheld point-of-care instrument, which is far more sensitive and exact in finding the sequence of the virus in their RNA, a type of genetic material within a virus. His goal is to be producing 5,000 to 10,000 instruments within eight weeks and 35,000 within 12 weeks, expanding afterward as needed.  While the current instrument will only be able to test for COVID-19, Birkmeyer expects that by early next year they will be able to test for all major viruses – including cold and flu viruses, swine flu, COVID, MERS, and SARS – from “wells” within a disk that goes into the kit and tell the patient exactly what they have.  LabWare is working with the Florida Department of Health to test its system, which uses iPads that are tied to a mobile hotspot with password-protected Wi-Fi and includes a battery pack, a thermal bar-code printer, and label stock. Ultimately the kit will be available with the Tangen GeneSpark Analyzer and COVID-19 assays.  “Florida started with three kits in Jacksonville and Duval County two weeks ago and now wants 100 of them for all 67 counties,” Kershner said. “Procurement could be a challenge in the current environment, but we’re wholly committed to fulfilling this order and ramping up for the quantities we are expecting” 

What Florida Thinks

Tawanda Washington, assistant director for the Florida Department of Health praised the ability to schedule electronically and keep everything organized through an electronic system, adding that they’ve seen fewer errors thanks in part to the installation of spell check on the system. “It also allows us to be more efficient with staffing and not needing to have a data entry person and a nurse to triage [since] the nurse that is triaging can enter the client’s information," she said. "That streamlines our processes and frees up a body to be used elsewhere.” Washington said her team has been focused during the pilot on identifying any items or processes that need to be tweaked. “The biggest challenge is having patience,” she said. “We are so excited to be able to use the system at its full capacity. The client is already registered, so the field staff would only need to scan an ID and move forward with testing.  It saves a lot of time.” Beyond the elimination of paperwork – which reduces the risk of a lab misreading handwritten responses – the Tangen instrument was developed to be handheld and used in the field as part of its development of a test for anthrax.  LabWare is the world leader for laboratory information management systems (LIMS), with 80% of the world’s clinical trials run through its system.   “Our customers need this,” Kershner said. “They can’t handle the amount of data they now receiving” in a manual format. 

Connections Matter: The Delaware Way

Kershner was at a Tangen board meeting when he learned about BARDA’s interest in a COVID-19 solution based on its previous experience with Tangen on an anthrax test. That got him thinking.  “They really weren’t prepared for commercialization,” Kershner said. “And then one day I realized that that if you’re going to test in the field, you need to be able to keep track of data with an information management system like ours.”  Kershner reached out to Delaware’s two senators, showing Sen. Chris Coons a prototype a week after they sat down for coffee. Sen. Tom Carper jumped all over it and helped with a lot of calls, Kershner added. Finally, Florida said it would be a partner to help LabWare understand the requirements for testing in the field.  “Before we can think about reopening Delaware and other parts of our country hit hard by COVID-19, we need to be able to test quickly and accurately, and then collect and share that data across states,” Carper said in a statement. “Delaware’s own LabWare is on to something here, and my hope is that their testing phase is successful so their product can help us through this crisis.”   The LabWare development team took their kit to Florida in mid-April and they immediately said it would solve a problem for the state.  “Everything was on paper with multiple touchpoints,” Kershner said. “It was taking 20 minutes at a drive-up testing facility to fill it out, with three people wearing PPE and using clipboards before moving on to a second station. The forms were then sent to a lab and transcribed and in many cases the handwriting was not matching up with the records. Our software eliminates all that and we created a mobile application that the whole thing is now running on.”  The pairing of LabWare and Tangen offers immediate possibilities and farther-reaching opportunities should the virus return this fall or next year. The Tangen test will cost about half what other tests cost and patients will get 10 results versus one.   “Our test will be the gold standard,” Birkmeyer said. “Before next flu season, we will have it so all the instruments can be reused and reduce the cost. Vance is enabling us to pull up to a mobile sampling places and record that person’s data and send it with the sample to a lab and find hot spots. Combining the two technologies means we can go out to a nursing home, check everyone, see who has COVID versus flu A or flu B, and communicate that immediately to the state lab.  “It’s a fantastic way to stop the spread because it prevents people who may have a positive COVID-19 test from wandering around and infecting everyone else.”    --Peter Osborne (posborne@delawarebusinesstimes.com)