VANCOUVER / USA News Group / As regulators in differing markets around the world continue to work on plans surrounding Covid-19 that will either open up their markets or lock them down further, a central component to all of these decisions is the efficacy of diagnostic tests. Debate rages on regarding the use of rapid antibodies testing vs RT-PCR testing, including a recent statement from the World Health Organization providing clarity on how to interpret results for specimens tested using PCR methodology. As regulators debate the accuracy of their data and how to act, other new diagnostic solutions continue to be presented from developers including BioVaxys Technology Corp. (CSE:BIOV) (OTC:LMNGF) (FSE:5LB), Abbott Laboratories (NYSE:ABT), Co-Diagnostics, Inc. (NASDAQ:CODX), Quest Diagnostics Incorporated (NYSE:DGX), and Thermo Fisher Scientific Inc. (NYSE:TMO).
One promising test dubbed Covid-T™ is being presented to the United States Food and Drug Administration (FDA), and it comes from BioVaxys Technology Corp. (CSE:BIOV) (OTC:LMNGF) (FSE:5LB). Clinical development has been initiated on the test, which is designed to detect the activity of what are known as T-cells.
In a recent US study , the presence of SARS-CoV-2-specific effector T-cells is likely a predictor of a person’s ability to recover from severe COVID-19. With reported vaccine shortages coming from across multiple markets, the idea is that enhanced testing could help administrators decide who gets it first, and who can more safely wait their turn.
"We believe that our low cost, scalable, easy-to-administer test for T cell immunity to SARS-CoV-2 may help solve the urgent global public health crisis of prioritizing the distribution of Covid-19 vaccines,” said James Passin, CEO of BioVaxys. “We look forward to rapidly advancing Covid-T™ towards commercialization."
By detecting T-cells, it’s believed that their presence can potentially identify safe and/or at-risk population, while also providing an ability to evaluate the effectiveness of any SARS-CoV-2 vaccine candidate in stimulating T-cell immunity—something that BioVaxys is also currently developing with Ohio State University, through their own vaccine platform.
"Although our vaccine programs are of major importance to us, Covid-T™ is a priority for BioVaxys, especially given the unmet need for such a simple, disposable, and accurate tool to test for the presence of T-cells against SARS-CoV-2," says BioVaxys President and Chief Operating Officer Ken Kovan.
The FDA has tentatively agreed to permit that BioVaxys can file for a pre-Emergency Use Authorization ("EUA") for Covid-T™. Under an EUA, the FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.
At this time, BioVaxys is not making any express or implied claims that its product line has the ability to eliminate, cure, or contain the Covid-19 (or SARS-2 Coronavirus). But the company has prepared the clinical development plan for Covid-T™, and engaged a global regulatory advisory group to provide strategic regulatory guidance, prepare an FDA pre-submission guidance package, recommend regulatory pathway, and support BioVaxys on their registration filing.
COVID-19 test sales have been very good to Abbott Laboratories (NYSE:ABT). Diagnostic solutions represented a whopping 111.1% growth year-over-year, with $2.4 billion in COVID-19 testing revenue boosting that segment to more than $4.3 billion in sales. Abbott has delivered more than 400 million COVID-19 diagnostic tests since the global health crisis began, with 300 million in Q4 2020 alone.
Abbott’s two tests are its BinaxNow rapid antigen test and its international counterpart, the PanBio COVID-19 Ag rapid diagnostic. The company has increased the manufacturing of these two tests to 100 million per month.
“We realized very early that a variety of different testing solutions would be required to handle the pandemic,” said CEO Robert Ford. “COVID testing has been a big driver for us and will continue to be a big driver. I expect testing demand will remain high even as the vaccine rolls out. I don’t think we’ve seen testing demand peak yet.”
Full year 2020 was also very kind to Thermo Fisher Scientific Inc. (NYSE:TMO), which saw its revenue grow 26% to $32.22 billion, driven by what the company called “ an extraordinary year of high-impact innovation, establishing leadership in COVID-19 testing .”
Their latest results highlighted the successes of their Applied Biosystems TaqPath COVID-19 Combo Kit and Amplitude Solution for high-throughput PCR-based testing.
"Our team executed extremely well and operated with speed at scale to help our customers and governments around the world respond to the pandemic and continue to advance their important work," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "I am proud that we delivered the strongest year of performance in our company's history. From a financial perspective, we generated exceptional growth in revenue, earnings and free cash flow for the quarter and the year."
At the beginning of 2020, Co-Diagnostics, Inc. (NASDAQ:CODX) was a penny stock, with shares selling for $0.90. By the end of the year, the stock was up to $9.30— a rise of 938% .
But clearly, the company wasn’t done yet. In late January 2021, Co-Diagnostics announced it had completed its own FDA submission for an extraction-free saliva COVID-19 test .
"Our new extraction-free saliva test has been developed as part of our ongoing commitment to providing improved COVID-19 diagnostics for high-throughput laboratory settings, using technology with additional potential point-of-care applications," said Dwight Egan, Co-Diagnostics CEO. "We believe that this technology will help to meet the domestic and global need for high-quality COVID-19 tests that can be processed quickly and affordably, while retaining the advantages of PCR testing over other testing alternatives. It also represents a major step forward in a new generation of PCR tests that can be widely more accessible, and we look forward to offering additional cutting-edge molecular diagnostic tools in the continuing battle against COVID-19 and other diseases."
For the seventh consecutive year, Quest Diagnostics Incorporated (NYSE:DGX) was named one of FORTUNE Magazine’s “ World’s Most Admired Companies ”.
"We are honored for the seventh consecutive year to receive this award, which belongs to our nearly 50,000 employees," said Steve Rusckowski, Chairman, CEO and President. "Over the past year they stepped up when our country needed them most by developing COVID-19 tests, building test capacity, innovating new testing models with our retail partners, transporting specimens, delivering results, and, of course, supporting our customers. They are heroes."
Year to date, shares of Quest Diagnostics have outperformed its industry —with the stock gaining 17.5% compared with 16.4% rise of the industry. At the time of its Q3 2020 earnings call, Quest had performed more than 22 million COVID-19 molecular and serology tests, more than any other provider.
Article Source: https://biotech-insider.com/the-small-biotech-company-that-all-the-majors-aspire-to-be/
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