Covid-19 Test Shortage Emphasized by New $70M Plan to Speed Up Authorizations

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Nov 09, 2021, 09:30 ET

VANCOUVER, B.C., Nov. 9, 2021 /PRNewswire/ -- USA News Group - New at-home Covid tests are on the way, according to the Biden administration, which announced a new $70 million plan to speed up authorization, especially in the wake of a shortage. A study from Kaiser showed that more than 1/3^rd of unvaccinated workers would rather quit their jobs than comply with a vaccine or testing mandate—and that number jumps to 72% if no testing option is offered. In response to this growing need for tests, the market is looking to diagnostic companies stepping up to the challenge, including Abbott Laboratories (NYSE:ABT), Becton, Dickinson and Company (NYSE:BDX), Quidel Corporation (NASDAQ:QDEL), Quest Diagnostics Incorporated (NYSE:DGX) and BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF).

In the case of BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF), instead of just testing for the virus itself, the company is developing a new test called CoviDTH that screens for a T cell-mediated immune response to SARS-CoV-2 along with WuXi Biologics—a $63-billion Chinese biomanufacturing partner.

The test is based on Delayed-Type Hypersensitivity ("DTH") technology, and is the world's first low cost, disposable, diagnostic to identify a T-cell immune response to the presence of SARS-CoV-2. So far, data suggests DTH testing may even be more accurate than current methods, by measuring the immune system's active infection response.

Recently the BioVaxys filed an international patent application through the Patent Cooperation Treaty to broaden CoviDRH's patent coverage beyond the USA. BioVaxys also recently filed international applications for registration of the CoviDTH trademark in selected markets including Canada, Mexico, European Union and United Kingdom.

"Given the urgent importance of commercializing a low-cost diagnostic for T cell immunity to Covid-19 in the context of the global pandemic, we believe that it's critical to protect Intellectual Property in key international markets as we continue to advance to towards the submission of an IND in the United States," said BioVaxys CEO James Passin.

Although CoviDTH diagnostic results are intended to be visually interpreted by a trained technician or healthcare provider, BioVaxys's additional patent claims include data capture and analysis via methods such as optical, infrared, and ultrasonic image processing.

BioVaxys already filed its application six months ago with the United States Patent and Trademark Office ("USPTO") for U.S. registration of its "CoviDTH" trademark.

Currently available Covid-10 immunity tests only measure antibodies. Typical measuring of T cell immunity requires the drawing of two ounces of blood from the test subject and a time-consuming and expensive analysis of the blood sample at laboratories possessing specialized equipment. Recent study results in humans showed that the DTH response is highly durable and persists for at least one year after COVID-19 exposure or vaccine administration.

It's believed that by detecting T-cell activation we 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 candidate BVX-0320, which is also set to be aided greatly by the WuXi partnership.

BioVaxys already announced that WuXi successfully completed synthesis of a recombinant SARS-CoV-2 s-protein, which the company can then use as part of its work towards potential a US Food and Drug Administration (FDA) approval for CoviDTH, as well as BVX-0320. Both CoviDTH and BVX-0320 are headed for clinical trials, with BioVaxys having begun preparing for a combined Phase I/II clinical study of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2.

Another test that's already widely available in the US is the QuickVue At-Home OTC COVID-19 Test from Quidel Corporation (NASDAQ:QDEL)— A rapid antigen test that enables consumers to perform the test themselves easily and get results within minutes without a doctor's prescription.

Most recently, the New York Jets NFL team announced a partnership with Quidel to donate 10,000 of these tests to local communities.

"Quidel is proud to be an official diagnostics partner of the New York Jets," said Douglas Bryant, President and CEO of Quidel. "The Jets organization's dedication to community service matches our own and we look forward to teaming up to provide urgently needed COVID-19 testing to underserved communities in the tri-state area."

Becton, Dickinson and Company (NYSE:BDX) (or 'BD') just began selling its own rapid Covid-19 test, the BD Veritor At-Home COVID-19 Test, which utilizes a smartphone app. It recently received Emergency Use Authorization from the FDA back in August.

"One of the unique things about this test is that it's really the very first test to actually have an interpreted digital result," said Dave Hickey, president of Becton Dickinson's life sciences business.

A packet of two BD Veritor at-home tests will retail for ~$40 , while Amazon, which has a testing partnership with the U.S. government, is selling the two-pack for $26.50.

The BinaxNOW test from Abbott Laboratories (NYSE:ABT) has seen a sales comeback, after revenues dipped by nearly a billion earlier this year. However, after U.S. vaccination rates plateaued and the delta variant spread, demand for rapid tests rose once again, driving Abbott's COVID-related diagnostic sales back up to $1.9 billion—with $1.6 billion coming from BinaxNow, Panbio and ID NOW alone.

According to data submitted to the FDA, the test correctly gave a positive result 84.6% of the time, compared to a PCR test, and correctly gave a negative result 98.5% of the time.

While Abbott has seen sales rise, Quest Diagnostics Incorporated (NYSE:DGX) saw a slowdown of Covid-19 testing in Q4 2021, saying that the average test volumes have declined nearly 10% so far in October, compared with third quarter-end and will fall further.

"While COVID testing has been strongly contributing to growth, we expect our base direct-to-consumer testing revenue to more than double this year," said Quest CEO Stephen Rusckowsk.

Quest recently committed to help K-12 schools in Texas, through an agreement with the Texas Department of State Health Services (DSHS) to provide COVID-19 Kindergarten through Senior (K-12) school testing services to support safer classroom learning throughout the state of Texas.

"Testing is critical to containing COVID-19's spread and creating safer environments for all of us," said Chad Richards, Vice President and General Manager, Southwest Region, Quest Diagnostics. "We applaud the state of Texas for recognizing the value of testing for children, faculty and staff, and look forward to bringing our high quality and convenient testing capabilities to participating schools in the program."

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