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Big Changes Coming to Covid Testing in Response to Rising Demand Under Latest Mandates


News provided by

USA News Group

28 Sep, 2021, 16:30 GMT

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FN Media Group Presents USA News Group News Commentary

VANCOUVER, BC, Sept. 28, 2021 /PRNewswire/ -- 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%.

For more information, please visit: https://biotech-today.com/heres-why-you-want-biotech-stocks-in-your-portfolio/ 

Article Source: 

USA News Group
http://USAnewsgroup.com
info@usanewsgroup.com

DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for BioVaxys Technology Corp. advertising and digital media from the company directly. There may be 3rd parties who may have shares of BioVaxys Technology Corp., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of BioVaxys Technology Corp. which were purchased as a part of a private placement. MIQ reserves the right to buy and sell, and will buy and sell shares of BioVaxys Technology Corp. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through further private placements and/or investment vehicles.

While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.

USA News Group is Source of all content listed above.  FN Media Group, LLC (FNM), is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with USA News Group or any company mentioned herein.  The commentary, views and opinions expressed in this release by USA News Group are solely those of USA News Group and are not shared by and do not reflect in any manner the views or opinions of FNM.  FNM is not liable for any investment decisions by its readers or subscribers.  FNM and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security.  FNM was not compensated by any public company mentioned herein to disseminate this press release.

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements.

Media Contact Information:
FN Media Group, LLC
Media Contact e-mail:  
editor@financialnewsmedia.com 
U.S. Phone: +1(954)345-0611

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