NEW YORK, July 23, 2020 /PRNewswire/ -- As surging rates of infection ripple across the United States and other parts of the world, many are waking up to a new reality: the beast is not fading away. Governments are ramping up precautions as cases of the current global health crisis rise to new heights in parts of the US and around the world—potentially wiping out two months of progress. There were 34,700 cases reported July 7, bringing the US close to its late-April peak of 36,400 new cases in one day, according to a count kept by Johns Hopkins University. Worldwide, more than 10 million people have been infected and over half a million have died from the current crisis. In the US, there are over 2.7 million confirmed cases and 128,496 reported deaths. More than 25 million Americans have been tested for the virus, fueling an ever-increasing demand for efficacy and mass-production in testing capabilities. According to infectious disease experts, there will be recurring outbreaks without more robust testing, contact tracing, and quarantine services across the country. LexaGene Holdings, Inc. (TSXV: LXG) (OTCQB: LXXGF) (LXG Profile), Co-Diagnostics Inc. (NASDAQ: CODX), and Abbot Laboratories (NYSE: ABT) are working to create fast and accurate tests, while drugmakers Moderna (NASDAQ: MRNA) and Novavax Inc. (NASDAQ: NVAX) are focused on delivering a plausible vaccine to the wanting market.
Testing and Tracing Essential for Reopening
The daily number of new cases in the US continues to rise, causing several states to slow down reopening plans. The US has now conducted more tests than any other country, but it's evident that ongoing testing and contact tracing is essential. The FDA has issued Emergency Use Authorization (EUA) to 157 potential tests, including 132 molecular tests, 24 antibody tests, and one antigen test, and continues to evaluate more potential candidates. Biotech company LexaGene (TSXV: LXG) (OTCQB: LXXGF) (LXG Profile) is currently moving through the EUA process to get its MiQLab pathogen detection device added to that list.
LexaGene's MiQLab genetic analyzer is capable of quickly and accurately detecting multiple pathogens, including the presence of the SARS-CoV-2 N-gene RNA, in contrived respiratory samples. Unlike most of the other testing solutions being used, which only look for signs of the current virus and have a significant false-negative rate, LexeGene's analyzer screens for multiple pathogens at once, including the current virus, influenza, adenovirus, RSV, metapneumovirus, and seasonal coronavirus. LexaGene has automated the entire workflow in an instrument designed to be placed at the point-of-need. It takes less than one minute of hands-on time to initiate sample processing for walk-away testing.
Technology Delivers Critical Feedback
In May, LexaGene placed its pre-commercial instrument into the Dartmouth-Hitchcock Medical Center (DHMC) Laboratory for Clinical Genomics and Advanced Technology. According to a recent update from the company, the technology has detected numerous positive samples from those tested to date.
"From the samples tested to date, we have detected numerous positive COVID-19 samples as well as negative samples, which are equally important," said LexaGene founder and CEO Dr. Jack Regan. "In contrast to many technologies that only provide a 'yes' or 'no' answer as to whether the virus was detected, LexaGene's technology provides quantitative data on how much virus is detected."
"By quantifying the amount of virus present, we can help clinicians determine if a patient is possibly early in the infection cycle, late in the infection cycle, or if their immune system successfully contained the growth of the virus. In the hospital study, we have detected COVID-19 positive samples that are more than 25,000-fold different in the amount of detected virus. Quickly identifying individuals with such high viral loads is especially important for disease containment," he added.
Potential Vaccine Could Be Available by Early 2021
Although vaccine-makers have been making progress in their developments, recent guidance from the US Food and Drug Administration (FDA) suggests that full approval on any given treatment likely won't happen until early 2021. The FDA's guidance, which was published on July 7, said any vaccine candidate would need to prove at least 50% more effective than a placebo to earn approval and that merely showing immune response data would not be enough. This waiting period for reliable treatment has created an urgent demand for fast and accurate testing to monitor the spread and help economies return to normal life.
However, as more experimental vaccines move into Phase 3 trials, the prospect of a plausible vaccine reaching the market by early 2021 increases. According to White House Coronavirus Task Force member and Director of the National Institutes of Allergy and Infectious Diseases, Dr. Anthony Fauci, the safety and effectiveness of a vaccine for COVID-19 should be known by "early winter," with 200 hundred million doses available for use in the US by early 2021.
Vaccine Hopes Bloom, Testing Demands Abound
Co-Diagnostics Inc. (NASDAQ: CODX) was issued an EUA in April for its Logix Smart COVID-19 kit, which is used for the qualitative detection of nucleic acid from SARS-CoV-2 in lower respiratory tract fluids and upper respiratory tract fluids from individuals who are suspected to have COVID-19. The company closed the first quarter of 2020 with $1.5 million in revenue due to demand for its Logix Smart COVID-19 test kits and saw gross margins of 71.5% on sales on the tests.
Abbott Labs (NYSE: ABT), which has received EUA for four of its COVID-19 tests, has continued to ramp up production to meet the growing demand for fast and accurate tests. The company's ID NOW test, which came under scrutiny after receiving a public warning from the FDA regarding possible accuracy concerns, has been praised by the White House, researchers, and clinicians and drugstore chains because it delivers positive results in as little as five minutes and negative results in 13 minutes. New data from an urgent care clinic study revealed promising test results. Although the results are encouraging, they still fall slightly below the FDA's testing policy, which requires at least 95% of positive samples. Abbott has shipped almost 4.5 million of its rapid ID NOW tests to all 50 states, Washington DC, Puerto Rico, and the Pacific Islands.
Moderna (NASDAQ: MRNA), which has been leading the COVID-19 vaccine race with its potential vaccine candidate, was expected to begin a phase 3 trial with 30,000 participants. However, the company has reportedly delayed the start date, possibly by a few weeks, as it makes changes to the trial plan. According to the report, protocol changes are common and the company will likely begin the trial this month.
After publication, Moderna CEO Stéphane Bancel told CNBC that the company has been working closely with the National Institutes of Health and the Trump Administration's Operation Warp Speed (OWS) and still intends to start the trial in July.
Meanwhile, late-stage biotech company Novavax Inc. (NASDAQ: NVAX) is moving ahead with plans to advance its potential vaccine candidate with new additions to its leadership team and $200 million in new funds via a preferred private placement. In May, Novavax enrolled the first participants in the Phase 1/2 clinical trial of its possible vaccine candidate, NVX–CoV2373, and expects to deliver preliminary immunogenicity and safety results from the Phase 1 portion of the trial in July.
With several late-stage trials taking place, Fauci is optimistic a successful vaccine will emerge by the end of the year and hopes to see more than one winner in the vaccine race. In the meantime, rapid and accurate tests are necessary for any hope of reopening.
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