Dr. Gerardine Gerri Botte, a professor of chemical engineering at Texas Tech University’s Edward E. Whitacre Jr. College of Engineering, announced UFC-19, an ultra-fast Covid-19 detection sensor. This test can detect the presence of the SARS-CoV-2 virus in saliva in 100 milliseconds.

The product developed results from a partnership between Texas Tech faculty research and the university’s entrepreneurial program accessible through Texas Tech’s Innovation Hub at Research Park.

The Innovation Hub is a resource within Texas Tech designed to nurture budding entrepreneurs. Students and faculty can tap the available resources for funding and mentorship. The 40,000 square-foot Innovation Hub helps entrepreneurs form new technology startup companies.

Dr. Gerardine Gerri Botte. Dr. Botte used her expertise in chemical engineering to found a biotech company called EviroTech. She joined the Texas Tech Division of Chemical Engineering in 2019. She has extensive research experience and is an entrepreneur.

Evirotech, in partnership with the Innovation Hub, received working capital from the Department of Defense and other sources such as the Prototype Fund, Presidents’ Innovation Award, and the National Science Foundation’s I-Corps program. The Defense Advanced Research Projects Agency (DARPA) works with the Department of Defense (DoD) “to make pivotal investments in breakthrough technologies for national security.”

Evirontech patented the technology. The company has applied to the US Food and Drug Administration for Emergency Use Authorization (EUA). If approved, people would have the option of rapid home testing that can sync directly to their phones. An accurate, easy-to-use home test will help people make safety decisions for themselves and their families.

EviroTech announced a four-million-dollar investment from German company 1701 Ventures GmbH to help the project get off the ground. This capital will allow EviroTech to begin production and distribution.

Scaling up rapid and frequent testing may be one of the tools the world needs to reopen fully. Covid-19 vaccines and immunity from natural infection have made a significant dent in Covid-19 cases. Texas has confirmed almost 2.5 million cases so far and currently is averaging about 1000 cases per day. At the same time, the rise of Covid-19 variants rages out of control in India and Brazil.

Covid testing has slowed in Texas, but it remains a crucial element in our fight against the pandemic. Testing allows doctors to diagnose and treat those who have Covid-19. Testing enables health workers to do contact tracing and find others who may have been exposed. Testing with genetic sequencing provides information to the public health system to track trends in specific communities.

University researchers across Texas have provided crucial data and cutting-edge innovations to assist public health experts in the fight against Covid-19.

Researchers at Texas A&M University recently identified a new Covid-19 variant called BV-1 by performing genetic sequencing on Covid strains from severe, mild, and asymptomatic infections. UT Southwestern genetic scientists in Dallas identified the first North Texas case of the Brazil P.1 Covid-19.

Texas Tech University’s collaboration to create the UFC-19 Ultra-fast Covid-19 detection sensor could be a way for public health experts to track the prevalence of the disease going forward. The ultra-fast COVID-19 sensor is an antigen-based electrochemical device. Antigen testing detects SARS-CoV-2 spike proteins at an early stage of infection.

Antigen testing is less expensive than PCR tests. It also detects active disease, unlike antibody tests which show evidence of a past Covid-19 infection. The UFC-19 Ultra Fast antigen detection sensor uses saliva instead of a deep sala swab.

A negative antigen test is slightly less accurate than a PCR test, but antigen testing is highly accurate at detecting if someone has an active COVID-19 infection. Antigen testing can also be performed as a point-of-care test. The UFC-19 Ultra Fast test results are available in 100 milliseconds.

The CDC has provided guidance on how to interpret rapid antigen testing.

As the US economy reopens, a scalable, rapid-testing solution could help schools, summer camps, airports, concert venues, and other public gatherings get back to normal. Individuals would have the ability to test themselves at home to detect an early, asymptomatic SARS-CoV-2 infection and prevent spreading the disease.

The UFC-19 Ultra Fast test requires only the detection sensor, a drop of saliva, and a cell phone. An individual would have the test results in seconds.

Take a tour of the Texas Tech Innovation Hub at Research Park here.

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Marketed to pregnant women in the 1950–60s as a cure for morning sickness, thousands of babies suffered severe disfiguring abnormalities of the arms and legs from the unrecognized dangers of the drug.

“Those who do not remember the past are doomed to repeat it.” — George Santayana

Thalidomide, an anticonvulsant drug, was developed in the 1950s by a German pharmaceutical company Chemie‐Grunenthal. A side effect of the medication was drowsiness. In 1956, Germany and most of Europe licensed it as an over-the-counter sleep aid.

Thalidomide had another beneficial side effect, the reduction of pregnancy morning sickness. The drug quickly became popular among pregnant women suffering from the common first-trimester symptom of nausea. Heavily marketed and sampled in physician offices as safe, Thalidomide became one of the world’s most popular medications.

Nausea and vomiting in pregnancy, hyperemesis gravidarum, occurs in the first trimester. Fetal organ development also occurs during this gestational age. A medication that interferes with fetal organogenesis should be avoided during this critical time in a baby’s development.

During the clinical trials for Thalidomide, animal tests did not study the effects of the drug during pregnancy. Rigorous worldwide guidelines for pharmaceutical testing were not in place as they are today. The result was over 10,000 children were born with severe and sometimes deadly Thalidomide-related disabilities around the world.

Although the drug was studied in clinical trials, the effects on pregnant women were unknown. The medication was prescribed by doctors and used by women “off-label” under the false presumption of safety.

It took years for the evidence of profound limb and other effects on babies to be linked back to maternal Thalidomide exposure. Later research uncovered the one compound, CPS49, that caused the severe limb defects (phocomelia) associated with Thalidomide exposure. Along the way to discovery, many babies died in utero or were lost to early miscarriage.

The true number of babies affected by Thalidomide will forever remain unknown

Primun non nocerere. Every first-year medical student learns this fundamental principle of bioethics. It means, “First, do no harm.” All physicians are asked to consider the potential for harm before any medical intervention. When faced with a problem, one must weigh the benefits against the potential risks or unintended consequences.

No matter how well-intentioned a treatment may be, one must always consider the unintended consequences. Medications have side effects. Surgical injuries occur. Weird and often unexpected outcomes show up during medical research. Viagra was originally developed for the treatment of high blood pressure until its side effect of inducing erections was discovered.

In clinical trials, the term for an unintended consequence is referred to as an “adverse event.” An adverse event is any untoward outcome experienced by a clinical trial patient.

An adverse event is documented, tracked, and traced regardless of a known causal relationship with the pharmaceutical or medical device being evaluated. Event tracking is a key tool in Good Clinical Practice guidelines to uncover unexpected outcomes and protect patient safety.

Patient safety comes first

Patient safety must be our priority to find a treatment for COVID-19. SARS-CoV-2 is a novel virus. This means the human race has never been exposed. We have no baseline immunity or protective antibodies. We do not have a vaccine or effective medication to treat it. Since we are all susceptible to Covid-19, our urgency to find an effective treatment is understandable.

Fear and panic fill our social media feeds. Click-bait headlines take us to untrustworthy news sites. We see our friends disregarding face cover recommendations. Some share false and inaccurate information. A lack of reliable information feeds worldwide anxiety.

Every day scientists learn more about SARS-CoV-2. But from a medical research perspective, we are starting from ground zero. In our desire to find a miracle cure we can not throw caution to the wind.

Blindly endorsing Hydroxychloroquine is dangerous when not supported by validated scientific evidence. After the hype surrounding Hydroxychloroquine, the FDA had to release a statement regarding the potential danger of using the drug outside of the hospital setting or in clinical trials. Politicians discussing home cleaning agents forced Lysol to issue a warning not to inject or ingest disinfectants. We must be skeptical when Televangelists exploit our fear by peddling snake oil.

Doctors must remember our societal responsibility to provide scientific and validated care when using social media sites. Celebrity physicians like Dr. Oz, Dr. Phil, and Dr. Drew have millions of fans who interpret their musings as facts. Youtube removed a controversial California Urgent Care center owners’ video downplaying the risk of COVID-19 after the American College and Emergency Physicians and the American Academy of Emergency Medicine issues a joint statement against physician misinformation

More than 100 tests for COVID-19 are coming to the market under the FDA Emergency Authorization Act. Each test will have different degrees of accuracy. We must exercise caution before public health policy gets ahead of the scientific understanding of antibody testing.

Research takes time. Anecdotal case reports and unpublished small cohort studies have value. These studies provide real-time data in an information vacuum to physicians in the field. A small study in New York yields interesting results regarding the use of heartburn medication in the treatment of COVID-19. These small clinical trials are only the first steps. They serve to identify the essential questions requiring further study in more robust trials. These studies do not mean we should all start taking medication for acid reflux.

The Food and Drug Administration oversight started with the passage of the 1906 Pure Food and Drugs Act, an effort to protect consumers against misbranded food and medications. Many may be frustrated by FDA oversight slowing down the process in COVID-19 research.

FDA oversight prevented Thalidomide from being approved in the United States. Dr. Frances Oldham Kelsey, an FDA medical officer, refused to approve Thalidomide due to a lack of clinical evidence regarding its safety despite heavy pressure from the pharmaceutical company. Her heroic and data-driven decisions saved thousands of babies.

First, do no harm

We must remember the legacy of Dr. Kelsey, value the FDA approval process, and respect Good Clinical Practice guidelines. Most countries in Europe approved Thalidomide for distribution at scale. Dr. Kelsey reviewed the available data and took action based on sound science.

We must take the same approach with COVID-19 Research. Case reports on Facebook should not trigger governmental actions. A small clinical trial in our Twitter feeds can not lead to changes in public policy. Doctors on Tik-Tok and Youtube should not determine when our economies reopen.

Even if a politician, religious leader or TV physician suggests it, do not drink, ingest or inject household cleaning products or disinfectants. Do not jump on the bandwagon after promising results from a small clinical trial or case report.

Allow the methodical scientific process to lead the way, and we find safe and effective treatments for COVID-19.

Further Reading

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