False Positives Scare Highlights Need for Changes to Covid-19 Testing Processes
VANCOUVER – USA News Group – A round of false positive test results caused a stir on the popular TV show The View recently, and highlighted flaws in current Covid-19 testing protocols. In the aftermath of US President Joe Biden’s pushing of mandatory vaccination/testing in the workplace, more problems have arisen, such as expensive testing costs, and rampant supply shortages . False positives such as those from the two hosts of The View can be quite costly, and are becoming increasingly likely , with false positive rates as high as 16.7%. The market is being tasked with addressing this issues, with a variety of innovative diagnostic options coming from developers and producers such as BioVaxys Technology Corp.(CSE:BIOV) (OTCQB:BVAXF), Becton, Dickinson and Company (NYSE:BDX), Qiagen N.V. (NYSE:QGEN), Abbott Laboratories (NYSE:ABT) and Quest Diagnostics Incorporated (NYSE:DGX).
A promising new test from BioVaxys Technology Corp.(CSE:BIOV) (OTCQB:BVAXF) is currently being tested, touted as the world’s first low cost, disposable, diagnostic to identify a T-cell immune response to the presence of SARS-CoV-2. Data from the use of this form of testing suggests it may even be more accurate than current methods.
The test, called CoviDTH, screens for a T cell-mediated immune response to SARS-CoV-2 instead of just for fragments of the virus itself. It’s based on Delayed-Type Hypersensitivity (“DTH“) technology, and is currently being developed with the assistance of large corporations, including $63-billion Chinese biomanufacturing partners, WuXi Biologics, and contract research services provider Inotiv, Inc., which has a market capitalization of $795 million.
In its July 2021 Written Response to BioVaxys on the Company’s request for a Pre-IND Type B review of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2, the US FDA indicated that animal toxicity studies for CoviDTH were not required and that the Company could start its clinical development program with a combined Phase I/II study.
Despite animal testing being discretionary, BioVaxys announced its started its planned in vivo animal toxicology study of CoviDTH in parallel with the preparation of an IND submission. Assisting with the process is Inotiv, Inc. who is evaluating the safety, tolerability, and toxicity of the purified recombinant SARS-CoV-2 s-protein provided by WuXi Biologics that is a principal constituent of CoviDTH in an intradermal research models.
“Based on the millions of people who have received COVID-19 vaccines that are based on in vivo cellular expression of SARS-CoV-2 s-spike protein, as well as the human DTH studies, we are confident that the toxicology study with Inotiv of the s-protein will likewise confirm the safety profile of CoviDTH,” said BioVaxys President and Chief Operating Officer Ken Kovan.
Using a personal smartphone to conduct Covid-19 testing is on its way, as the FDA granted an Emergency Use Application (EUA) to Becton, Dickinson and Company (NYSE:BDX) (or ‘BD’) for its BD VeritorTM At-Home Covid-19 Test—the first at-home Covid-19 rapid antigen test to use computer vision technology in a smartphone to interpret and provide digital display of testing results.
"The rise in COVID-19 cases from the Delta variant has increased the demand for at-home testing, and the BD Veritor™ At-Home COVID-19 Test is an easy-to-use test with definitive digital results that is ideal for use in the home," said Dave Hickey, president of Life Sciences for BD. "New mandates from governments and businesses are specifying the need for periodic testing for those who cannot or chose not to be vaccinated, and this new test may help businesses, governments or schools fulfill those requirements."
Designed to be easily performed at home by people 14 years of age or older, the BD Veritor™ At-Home COVID-19 Test uses the Scanwell Health's app to provide clear digital results in 15 minutes. If samples are collected by an adult, the test can also be used for children as young as two years old.
As confidence in home testing grows, German genetic testing specialists Qiagen N.V. (NYSE:QGEN) is seeking to capitalize and launch more products to detect everyday infections. So far, Qiagen’s net profit of $250m in the first six months of 2021 has been almost double that of the same period in 2020, when Covid-19 testing was still limited.
“[Demand for Covid-19 tests] completely changed the paradigm for a company like ours,” Thierry Bernard, chief executive, told the Financial Times . The shift exploded the value of Qiagen, which saw multibillion takeover attempts from majors in the industry last year.
Similar demand growth has been witnessed by Abbott Laboratories (NYSE:ABT), especially for its BinaxNOW tests, which spokesperson for the company, John Koval, claims are seeing “unprecedented demand”.
“Today, there are tens of millions of BinaxNOW tests in various settings and supply chains,” Koval said in an email . “We're working with our customers to ensure tests get to where they're most needed and we're ramping back up, as we did last year… There will be some supply constraints over the coming weeks as increased capacity comes online.”
Perhaps even bigger new for Abbott was the report from Reuters that the US government is set to purchase more than half a billion dollars’ worth of rapid coronavirus tests for point-of-care situations, such as nursing homes and other high risk populations.
After initiating a dull 2021 outlook back in July, Quest Diagnostics Incorporated (NYSE:DGX) updated its outlook based on surging demand for COVID-19 tests. Earlier in September, the company significantly raised its full-year projection.
"There is simply nowhere near enough supply of POC or OTC tests (PCR tests could be used for regular screening but come with logistical and cost hurdles) today to meet the demand of the U.S. government (280 million tests), employers (likely millions of tests per week), schools, traditional healthcare settings, and retail demand," the company wrote in the update.
As per the increase, the update included a prediction of full-year net revenues ranging $9.84-$10.09 billion, indicating a 4.3-6.9% improvement from 2020. Much of this comes from a new assumption of average volumes of at least 40,000 molecular tests daily for the second half of the year, doubling upon the previous guidance of 20,000.
According to a new global diagnostic enzyme market report , the market is expected to grow from $3.23 billion in 2020 to $3.53 billion in 2021 at a compound annual growth rate (CAGR) of 9.3%. This market is now expected to reach $4.44 billion in 2025 at a CAGR of 6%.
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