The Coronavirus Disease (COVID-19) pandemic has caused unprecedented changes to our lifestyles and the way our businesses operate. Policymakers are in the uncomfortable position of achieving a balance that minimizes the economic risks of prolonged business closures, while simultaneously addressing the threat to public safety and overburdened hospitals if there is another spike in infection rates. The pressure to develop reliable, rapid tests, effective safety products, treatments and vaccines as quickly as possible has led to several regulatory changes to reduce the burden on manufacturers and labs and accelerate the availability of innovative products, prior to their full review by regulatory bodies. An executive order was announced August 19, 2020, declaring that labs and commercial manufacturers will no longer be required to receive approval from the Food and Drug Administration (FDA) prior to releasing tests they develop in house (also called “laboratory-developed tests,” or LDTs), although labs will continue to be regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). Many biotechnology companies have shifted their focus entirely towards developing solutions that will enable businesses to resume normal operations and ensure public safety. Two North Texas companies have been at the forefront of these efforts, developing innovative products that will dramatically improve the accuracy of tests and the long-term efficacy of di fecting procedures.
Allied BioScience, Inc. (ABS), headquartered in Plano, develops antimicrobial surface coatings that provide continuous protection against the spread of infectious diseases. The drawback of typical disinfecting products is that they must be reapplied every single time a surface comes into contact with a contaminant. Realizing the need for a more long-term and sustainable solution, ABS developed SurfaceWise in 2008. Clinical trials showed that a single application of SurfaceWise inhibited the growth of bacteria and superbugs and prevented them from colonizing for up to 90 days, causing dramatic reductions in the rate of patient infections in hospitals. The product is applied using an electrostatic sprayer, which releases negatively charged particles that cling to every surface, crack and crevice of both soft and hard materials, making it very effective for disinfecting large areas. The hard polymer coating dries quickly and is completely transparent and non-toxic. The Dallas Cowboys and the Dallas Mavericks have been using SurfaceWise for years to prevent the spread of pathogens, especially staph infections like MRSA, a very serious and difficult-to-treat infection that can compromise an athlete’s career.
Earlier this year, ABS began developing SurfaceWise2, a more durable formula designed to kill bacteria and viruses more rapidly than the original formula. After discovering its ability to quickly kill the notoriously hardy Norovirus, ABS realized that the new formula would also effectively prevent the spread of the coronavirus, allowing business to safely resume pre-pandemic cleaning procedures. SurfaceWise2 has been proven to inactivate viruses such as SARS-CoV-2, the virus that causes COVID-19, within two hours after application and continues to be effective for up to 90 days. It is the first and only product that continuously provides non-toxic antiviral protection over an extended period of time after a single application. On August 24, 2020, the U.S. Environmental Protection Agency (EPA) approved an emergency waiver submitted by the Texas Department of Agriculture that allows the State of Texas to use SurfaceWise2 in a limited set of pre-approved locations. “There is no higher priority for the Trump Administration than protecting the health and safety of Americans, and I want to thank those who have worked with us to achieve this major milestone. Since day one, I have been committed to ensuring that Americans have as many tools as possible to protect their families, and today we are delivering on that promise by approving the first-ever long-lasting antiviral product that will help fight the spread of the novel coronavirus,” said EPA Administrator Andrew Wheeler during a press release.
The EPA is the regulatory body in charge of reviewing and registering products that may affect the environment. Antimicrobial pesticides, including disinfectants intended for use on pathogens like SARS-CoV-2, must be approved for specific, registered uses. The EPA grants Section 18 Emergency Exemptions to state and federal agencies if they have an urgent need to use a pesticide prior to the full completion of that pesticide’s registration process, or prior to being approved for the requested use. These exemptions are typically filed when an agricultural area experiences an invasive pest outbreak, but they are rarely granted during a public health crisis. The recent exemption enables the State of Texas to permit American Airlines to use SurfaceWise2 in a limited number of approved facilities and planes, as well as two Total Orthopedics Sports & Spine Clinic locations for a period of one year. “Texas is proud to once again step up and join the fight against this virus. This Section 18 exemption gives businesses another tool to protect consumers as we try to bring our economy back. Thank you, President Trump and EPA Administrator Wheeler, for your commitment to the safety of the American people and to ending this pandemic that is choking our economy and our way of life,” said Texas Agriculture Commissioner Sid Miller in a press release. The announcement came shortly after reports that the death toll in Texas exceeded 10,000, while the number of reported cases in the United States exceeded 5.5 million, resulting in more than 173,000 deaths.
Emergency exemptions are filed and approved by the EPA on a state by state basis and each must be backed by an applicant. ABS is ready to file exemptions in all 50 states, including Puerto Rico, with American Airlines being the applicant in ten of those states. The initial locations permitted to use SurfaceWise2 were chosen because Dallas is a hub for American Airlines and will therefore maximize their use of the product by enabling them to disinfect all planes that pass through DFW Airport; the spine clinics were chosen because of the urgent need to expedite availability to medical centers. ABS has also been pursuing the standard, non-emergency Section 3 approval, which would make SurfaceWise2 available nationwide and eliminate the need to file waivers in each state. The Section 3 approval process takes longer to complete and the product’s claims are so unique that the EPA was prompted to create a new category for residual antiviral products. Prior to SurfaceWise, there were no antiviral products claiming to be effective for as long as 90 days, so a new protocol had to be created in order to allow the EPA to even test those claims. Rather than delaying the availability of its product, ABS secured an initial EPA approval supporting its claim of antiviral and bacterial protection that remains effective for up to seven days, although independent lab results have shown that the protection does in fact last up to 90 days.
Regardless of which approval route ABS pursues, they anticipate that SurfaceWise2 will be available in all 50 states by the end of the year, if not sooner. Although it will not eliminate the need for regular, routine cleaning and disinfecting procedures, ABS’s innovative product will provide an added layer of protection and will contribute towards helping consumers start to feel more comfortable traveling and visiting businesses or public areas. “We are thrilled to work closely with the EPA on approval for SurfaceWise2, which enables people to get back to living their lives. This initial EPA approval clears the way to effectively protect people against COVID-19 as a residual solution proven to provide long-term, non-toxic surface protection from viruses, including coronaviruses,” said Allied BioScience CEO Michael Ruley in a press release. “We know how tirelessly the EPA has worked to evaluate a litany of innovative products and we are excited to provide this added layer of defense for our country.” Mr. Ruley moved ABS to Texas after becoming CEO in 2014. Prior to joining the company, he held an extensive amount of leadership roles in the Telecomm industry. Mr. Ruley’s wife, Dee Lincoln, is the award-winning restauranteur who founded the Dee Lincoln steakhouse, as well as the Del Frisco’s chain of restaurants, among other successful ventures.
ABS has several major partners lined up, and is prepared to immediately roll out SurfaceWise2 on a mass scale as soon as it receives full EPA approval. The product is manufactured entirely in the United States and ABS has the capacity to produce tens of thousands of gallons per day. It has already gained the interest of several major retailers, including Amazon, Walmart and Starbucks, and there are also plans to use the product in schools and transit settings. As the virus is thought to be contracted mainly from close personal contact and aerosol particles, ABS is currently researching ways to integrate SurfaceWise2 into home and commercial HVAC systems, air filters and even face masks. Although the product will initially only be available commercially, the company hopes to eventually produce a residential product for high touch areas like doorknobs and kitchen counters. “If we combine surface protection, air protection and a vaccine, we can put this thing to rest … and that’s the plan,” says Mr. Ruley. “Our country needs it, and the world needs it.” ABS plans to move to Frisco in the near future and has been considering locations around The Star, where they have been testing the efficacy of SurfaceWise for years.
InspectIR Systems is a local Frisco company making tremendous contributions to the efforts to fight the spread of COVID-19. InspectIR is a research and development company that manufactures breathalyzer boxes capable of detecting hundreds of volatile organic compounds (VOCs) on the breath, including illicit substances, such as opioids or cannabis. Their device was developed with the intent of providing roadside and mobile, real-time testing to help health professionals and law enforcement agents face the challenges resulting from the opioid epidemic and the legalization of cannabis products. After the severity of the COVID-19 pandemic became apparent, the company began to dedicate its efforts toward developing a solution. “As most of us have experienced, the world has changed due to the coronavirus pandemic. We challenged our development teams with a simple question: ‘Can we help?’ We quickly realized our devices could identify COVID-19 in the breath and help with the unique circumstances facing the U.S. and the world right now. It provides detection of VOCs on the breath, including COVID-19, Influenza A and more, in as little as 90 seconds. This means health professionals can almost immediately have an accurate diagnosis and begin effectively treating the patient – giving them a far better chance for a positive outcome,” said InspectIR CEO Tim Wing in a press release.
In partnership with Dr. Guido Verbeck, Associate Dean of Research in the College of Science at the University of North Texas, InspectIR was able to develop the first commercially available device that analyzes breath samples directly using a mini mass spectrometer. “Using a mass spectrometer, coupled with the InspectIR patented technology, our device can detect and identify chemical molecules in the breath. That means it can literally smell and identify substances on your breath,” explains Dr. Verbeck. Their product is unique in that it is the only testing methodology currently available that does not create cross reactivity, which can occur when a test reacts to solvents or other reagents that have been added to the specimen being analyzed and results in a false positive reading. One of the major obstacles throughout the pandemic has been the frequency of false positives and false negatives, which have been estimated to occur in nearly 50 percent of all cases. The failure to identify the illness as quickly as possible not only delays patients from receiving treatment, but it can also encourage the spread of the virus due to the person’s failure to self-quarantine. “Accuracy has been an issue with COVID-19 testing since the beginning of the crisis,” said InspectIR COO John Redmond. “Our device is specifically designed for trace detection in the high part-per-trillion. We believe it will provide the most accurate results on the market. There are few viable non-invasive detection tools available today.” InspectIR’s groundbreaking technology will provide an invaluable tool to care providers as they struggle to obtain accurate and rapid test results and to deliver effective treatment to patients
Many people have wondered why there has been so much difficulty developing accurate tests for COVID-19. There are several factors to blame. When determining the accuracy of a test, manufacturers check for cross reactivity and interfering substances. Cross reactivity results in false positives and can occur as a result of the reason listed previously, or when a test encounters a virus with a very similar genetic composition to the targeted virus. For example, a test may inaccurately detect SARS-CoV-2 when analyzing a specimen containing the original SARS, MERS (Middle East Respiratory Syndrome), or Influenza. Conversely, interfering substances cause false negatives, and include a variety of items, such as mouthwash, medications, eating too recently prior to a test, or even mucin (a substance present in all saliva). Oftentimes tests are designed to target a specific part of a virus’ gene, but the virus mutates, causing inaccurate readings until the test is expanded to detect additional parts of the targeted genes. The reason we need a different flu vaccine each year is because the flu virus continually mutates. A virus can also degrade, or become unstable, after collection due to environmental factors, such as high temperatures, causing the genetic material to break down too much for the test to identify it. Fortunately, InspectIR’s new device will not be vulnerable to the latter, as it does not collect any genetic material.
InspectIR has already submitted an Emergency Use Authorization (EUA) application to the FDA for the breathalyzer box, which is considered a medical device as a result of its intended use. Per current FDA regulations, once a company submits an EUA, licensed clinical labs are allowed to use their product, prior to FDA review or approval, as long as the FDA is notified of their intent. Clinical trials are currently being conducted at Medical City Dallas in partnership with Dr. Gustavo Day in order to test the accuracy of the device in detecting COVID-19. The anticipated product launch date has not yet been announced, but once the device is available, it will offer care providers the most efficient COVID-19 testing method to date.
The combined efforts of these two life science companies and their groundbreaking new products represent critical scientific breakthroughs in the search for solutions to the global pandemic. As businesses struggle to make ends meet and to implement financially and environmentally sustainable practices, SurfaceWise2 will provide a much-needed relief from the excessive cleaning regimens businesses have been forced to endure. InspectIR’s breathalyzer box will also be a game-changer, enabling care providers to overcome the frustrating roadblock caused by the notoriously inaccurate COVID-19 tests currently available. With the holiday season rapidly approaching, schools reopening and flu season right around the corner, it is comforting to know that airlines and businesses will have additional tools to prevent the spread of pathogens. Frisco residents can do their part in the coming months by remembering the importance of adhering to all recommended safety precautions, as we all continue to work together to keep our communities safe and healthy.
Juliet Cimler is a freelance writer and project manager for a biotech consulting firm in Frisco. She has a B.S. in Business Administration and is pursuing an M.S. in Computer Information Systems.