Tuesday, October 4, 2022


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Covid-19 Tests Innovations Drawing New Interest from FDA and Consortiums

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Two of the world’s most prominent billionaires, George Soros and Bill Gates, recently made headlines backing a consortium to buy UK Covid-19 test maker Mologic for $41 million ahead of a new initiative of a global rollout for rapid result testing. As demand shifts, newer innovations from not only from Mologic are gaining attention, including a new T-Cell Immune Response diagnostic from BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV), antigen tests from Abbott Laboratories (NYSE: ABT), Chembio Diagnostics, Inc. (NASDAQ: CEMI) and Quidel Corporation (NASDAQ: QDEL), and antibody tests from Ortho Clinical Diagnostics Holdings plc (NASDAQ: OCDX).

For many establishments, the tests help to assess levels of risk for patrons, employees and other interested parties. Before entering a potentially higher-risk zone, patients could soon have a better idea of their own body’s capability of resisting an onslaught from Covid-19—namely through quantifying their T-Cell activity.

Earlier this year, a US study suggested that 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.

Now the FDA has released guidance to BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV) for its T-cell immune response diagnostic platform CoviDTH to begin Phase I/II Clinicial Trials.

“We are pleased to advance CoviDTH towards clinical trials,” said James Passin, BioVaxys CEO. “We believe that mass screening for T cell immunity to Covid-19 will represent a critical tool for public health authorities to address the continued pandemic, as Covid variants continue to circulate and major governments in the southern hemisphere enact new lockdown policies.”

BioVaxys submitted a Pre-Investigational New Drug (“IND”) meeting request and briefing package with the FDA’s Center for Biologics Evaluation and Research (CBER) for CoviDTH earlier this year.

The FDA found the Chemistry, Manufacturing and Controls, and other elements of the clinical development program proposed by BioVaxys to be acceptable and provided guidance and feedback supportive of BioVaxys’ clinical development plans for CoviDTH. Based on this feedback, BioVaxys will begin preparation of an IND application to support a Phase I/II safety & efficacy study.

“With the guidance we received from this FDA review, BioVaxys is now able to begin preparing its IND,” stated BioVaxys President and Chief Operating Officer Ken Kovan.

The Pre-IND review is a critical step in the US regulatory approval process, as it affords an opportunity for study sponsor companies to seek clarification from the FDA on clinical trials design, clinical materials manufacturing, quality controls, etc.

“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.

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.

Earlier in July, Abbott Laboratories (NYSE: ABT) had to recently lay off 400 workers at its Maine facilities amid a drop in demand for their Covid-19 tests, after the company cut its 2021 outlook in June.

“We’ve recently seen a rapid decline in COVID-19 testing demand and anticipate this trend will continue, which led us to adjust our full-year guidance,” said Robert B. Ford, President and CEO of Abbott. “At the same time, excluding COVID-19 tests, our organic base business growth is accelerating, we continue to see improving end-markets and our new product pipeline continues to be highly productive.”

However, later in July, Abbott was reported to be working to import the PanBio Covid-19 self tests from Korea. The PanBio professional test demonstrated 95.7% sensitivity and 97.6% specificity when benchmarked against RT-PCR tests.

“Abbott is the only diagnostics manufacturer to provide performance data on a rapid antigen test specific for use on children 15 years and younger, including infants,” the company claimed.

Back in April, Chembio Diagnostics, Inc. (NASDAQ: CEMI) announced the US commercial launch of a diagnostic tool to differentiate between Covid-19 and flu. Now in Brazil, the company has announced a $28.3-million purchase order from Bio-Manguinhos for DPP SARS-CoV-2 antigen tests for delivery later this year.

The DPP SARS-CoV-2 Antigen test is designed to detect the SARS-CoV-2 antigen, which indicates an active COVID-19 infection, in only 20 minutes using a minimally invasive nasal swab.

“We are pleased to significantly expand our customer relationship with Bio-Manguinhos to address the testing needs surrounding COVID-19,” said Javan Esfandiari, Chembio’s Executive VP, Chief Science & Technology Officer. “Enabling providers to test patients at the point-of-care and determine their infection status in only 20 minutes can be one of the most effective methods for controlling the spread of COVID-19 and improving patient outcomes.”

A new NIH-funded screening study has recently built a case for frequent Covid-19 antigen testing.

The study used the Sofia SARS Antigen Fluorescent Immunoassay device from Quidel Corporation (NASDAQ: QDEL), against a separate PCR test (Alinity) from Abbott. The Sofia test was the first rapid antigen test to get an FDA greenlight, back in May of last year.

Most recently, the company has announced it entering a partnership with the State of Delaware to implement full-service, turn-key Covid-19 testing as part of the reopening of K-12 schools in the fall.

Now the FDA has issued another “first”, as the regulatory body recently granted Emergency Use Authorization (EUA) to Ortho Clinical Diagnostics Holdings plc (NASDAQ: OCDX) for its Quantitative Covid-19 IgG Antibody Test.

“The development of the VITROS Anti-SARS-CoV-2 IgG Quantitative Test shows Ortho’s leadership in response to the need for standardization of SARS-CoV-2 serological methods currently used,” said Ivan Salgo, MD, head of medical, clinical, and scientific affairs for Ortho Clinical Diagnostics. “Ortho’s quantitative COVID-19 IgG antibody test, which targets the spike protein, is an important tool to help health care and policy teams to understand long-term antibody responses to SARS-CoV-2.”

By targeting the S1 spike protein, and calibrating to the WHO International Standard for anti-SARS-CoV-2 IgG antibodies, Ortho’s test provides uniform data as a first step toward understanding the rise and fall of antibodies in individuals and the long-term impacts of the COVID-19 pandemic on communities and the overall population.

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