Why New Covid-19 Test Supplies Will Be Needed Soon in Wake of US President's New OSHA Mandates

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Sep 14, 2021, 09:45 ET

VANCOUVER, BC, Sept. 14, 2021 /PRNewswire/ -- USA News Group - More than 80 million workers in the United States are now facing a new vaccine/testing mandate being pushed by the Biden Administration through the Occupational Safety and Health Administration (OSHA) on employers with +100 employees. For many workplaces, this could mean a drastic increase in demand for testing equipment, against a supply that's already under stress and encountering major shortages. In order to meet this coming need, several new developments in testing, immunity enhancement and other biotechnologies are in progress including advancements coming from BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF), Quest Diagnostics Incorporated (NYSE:DGX), Quidel Corporation (NASDAQ:QDEL), Qiagen N.V. (NYSE:QGEN) and Abbott Laboratories (NYSE:ABT).

Through its partnership with $63-billion Chinese bio manufacturer WuXi Biologics, BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF) just announced it's moved one step closer to its goal of launching a new test that screens for a T cell-mediated immune response to SARS-CoV-2. Data for this form of testing suggests it may even be more accurate than current methods, by measuring the immune system's active infection response.

With WuXi completing the synthesis of a recombinant SARS-CoV-2 s-protein, BioVaxys is greatly aided in the leadup to potential US Food and Drug Administration (FDA) approval for its immunodiagnostic product CoviDTH, as well as BVX-0320, the company's COVID-19 vaccine candidate.

Both products are headed for clinical trials, with BioVaxys having begun preparing an IND submission to the FDA for a combined Phase I/II clinical study of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2.

"The production of the recombinant s-protein using WuXi Biologics' proprietary cell expression system is a significant milestone for Biovaxys," said Kenneth Kovan, President and COO of BioVaxys. "We not only have a high production yield of protein, but also now have the ability and know-how to produce protein in large scale with the level of purity, consistency and protein characterization required by the FDA for our clinical studies and commercial-scale yields."

Under the terms of the March 11^th, 2021 agreement, WuXi Biologics has designed and validated the bioproduction protocol and synthesized high yields of fully characterized, SARS-CoV-2 s-protein for BioVaxys' Good Laboratory Practice (GLP) preclinical of CoviDTH which begins this month.

Recent study results in humans showed that the delayed type hypersensitivity (DTH) response (the basis for BioVaxys' CoviDTH) is highly durable and persists for at least one year after COVID-19 exposure or vaccine administration.

By detecting T-cell activation, it's believed that this can potentially identify safe and/or at-risk populations, while also providing an ability to evaluate the effectiveness of any SARS-CoV-2 vaccine in stimulating T-cell immunity—something that BioVaxys is also currently developing, through their SARS-CoV-2 vaccine BVX-0320, which is also set to be aided greatly by the WuXi partnership.

Immediately after US President Joe Biden's announcement regarding vaccinations and testing, German genetic testing specialists Qiagen N.V. (NYSE:QGEN) stated the company supports the new mandates.

"We strongly support all initiatives aiming to increase vaccination rates especially at the workplace," Qiagen told Reuters in an email.

To support the drive, the White House said it will spend nearly $2 billion on 280 million rapid COVID-19 tests.

One of the largest US manufacturers of rapid COVID-19 tests, Abbott Laboratories (NYSE:ABT) said it was quickly working to hire additional employees and scale up manufacturing of its two tests: BinaxNOW and ID NOW test kits. The move comes on the heels after the manufacturer ordered its employees to destroy millions of tests, and dismissed 2,000 employees at the end of August. Now Abbott is working to hire back hundreds of workers, among which under the new mandates will also have to be vaccinated or tested weekly.

So while demand for the 15-minute antigen test, BinaxNOW, soared as people returned to schools and offices, Abbott just one month ago reportedly told thousands of newly interested companies that it cannot equip their testing programs in the near future, including CVS, Rite Aid and Walgreens locations which were selling out of the at-home version, and Amazon which had shipping delays of up to three weeks.

Picking up some of the slack is Quidel Corporation (NASDAQ:QDEL), which at the beginning of the month announced a launch of its QuickVue® at-home, over-the-counter COVID-19 tests to CVS Pharmacy.

The non-prescription rapid antigen tests are now available at more than 7,000 CVS Pharmacy locations.

"Making QuickVue® At-Home OTC COVID-19 Tests conveniently available in-store and online at CVS Pharmacy further supports our shared commitment in meeting the testing needs of American families," said Douglas Bryant, president and CEO of Quidel. "We experienced a recent surge in demand for our portfolio of Sofia SARS and QuickVue COVID-19 rapid antigen tests, and adding capacity through CVS Pharmacy, a leader in providing testing access throughout the pandemic, will help address customers' demand."

As per the announcement, Quidel says that it's continuing to add manufacturing lines and are on-track to reach its target run-rate capacity of approximately 70 million rapid antigen COVID-19 tests per month by the end of the year

The morning of the Biden announcement, Quest Diagnostics Incorporated (NYSE:DGX) updated its own outlook on the surging demand of COVID-19 tests. After initiating a dull 2021 outlook back in July, Quest has now come out with a significant rise in its full-year projection.

The timely projection increase included a prediction of full-year net revenues ranging $9.84-$10.09 billion, indicating a 4.3-6.9% improvement from 2020.

Quest's low-end outlook now assumes average volumes of at least 40,000 molecular tests daily for the second half of the year versus previous guidance of 20,000.

"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.

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