NEW YORK, NY—PharmaCyte Biotech (OTCQB: PMCB) may have what the White House Coronavirus Task Force is looking for just as COVID-19 cases are surging across the country. Last week, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the White House Coronavirus Task Force is now considering sample pooling, also known as pool testing, as a way to ramp up local authorities’ ability to determine the extent of the infection in their areas.
“It’s not going well. I have to tell you, it’s not going well,” Dr. Fauci said in an interview with CNBC. “What we need to do is we need to rethink, and we are right now, the idea of many more tests getting into the community and even pooling tests.”
Pool testing involves combining or pooling samples from multiple people and testing them together in a single batch. It’s a way to efficiently increase the volume of tests to quickly churn through what is expected to be mostly negative samples.
PharmaCyte’s COVID-19 testing kits have exactly that capability. The company licensed its COVID-19 test from Hai Kang Life Corporation in Hong Kong and is currently awaiting Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). One of the key selling points for PharmaCyte’s testing kits is that they are ideally suited for the mass testing that Dr. Fauci is convinced will make a difference.
Dr. Deborah Birx, who along with Dr. Fauci play a lead role on the White House Coronavirus Task Force, said, “Pooling would give us the capacity to go from half a million tests a day to potentially 5 million individuals tested per day.”
In addition to combating the recent surge in coronavirus cases, PharmaCyte’s COVID-19 test could be the perfect option to ensure a safer reopening of the entire country with a mass-testing solution in place that all companies, organizations, schools, and universities could embrace with confidence.
It was in April of this year that a report titled, “Roadmap to Pandemic Resilience,” was released by a blue-ribbon panel of thought leaders across the political spectrum which included economists, social scientists, lawyers and ethicists, and according to that report, there’s a growing consensus that points to one key move necessary to put Americans back to work—dramatically upscaling testing.
During a recent Coronavirus Task Force briefing, it was reported that 48 separate coronavirus tests have been authorized and that the U.S. FDA is working with 300 companies and laboratories to widen the nation’s testing capacity. According to the “Roadmap to Pandemic Resilience” report, “test producers will need to deliver 5 million tests per day to safely open parts of the economy by late July,” and to “fully re-mobilize the economy, the country will need to see testing grow to 20 million a day.”
With numbers like these, it’s clear that many more testing companies will need to join the fight to improve the daily testing requirement. PharmaCyte’s COVID-19 test should move to the front of the line once its Emergency Use Authorization is granted by the FDA because not only does its developer, Hai Kang’s founder and current Chairman, Professor Albert Cheung-Hoi Yu, Ph.D., call it the “most sensitive test in the world” to detect the virus that causes COVID-19, but also because of its capability to offer pool testing.
PharmaCyte’s COVID-19 test is capable of testing hundreds of people at one time using “sample pooling” or “population screening.” The ability to test hundreds at one time will allow PharmaCyte to leverage the sensitivity of the test to local, state and government agencies, communities, companies, organizations, schools, etc., to test a pool of employees to get these entities back to work while giving them the means to do continuous testing into the future, which will create a safer environment for employees to feel comfortable in the workplace.
Professor Yu said of the ability of this COVID-19 test to do pool testing, “Where large volumes of tests are required, pooling of samples for ERT-PCR testing can increase sample throughput. The pooling strategy expedites the screening process for which the accuracy can be ensured by the highly sensitive ERT-PCR test method.”
Sample pooling is accomplished by swabbing a large group and then each of the samples is pooled into 1 “test reaction,” and if the test results are negative, then everyone in the group is free of the virus. However, if the test results are positive, then each person in that pool will be tested individually to determine who among them has the virus.
This capability is possible because the company’s COVID-19 test is extremely sensitive thus eliminating the potential for false-negative results. According to Professor Yu, the reason the test is so sensitive is that it can detect the virus well below the threshold, “Compared to the routine RT-PCR tests, our test is more sensitive. Its limit of detection is down to 1-2 copies (of RNA) per reaction, so it is most useful for the detection of infections where the viral load is low, for example, during the pre-symptomatic and post-symptomatic phases and for asymptomatic cases. These situations are where the routine RT-PCR tests most likely give false-negative results.”
He continued, “In comparison with antibody-based tests, because they have a delay time before the antibodies reach detectable levels, likely post-infection over seven days, our test is more accurate than antibody-based tests for early detection.”
It is very likely that the United States will need to undergo testing for COVID-19 well beyond 2020 and potentially forever.
Professor Yu agrees, “There is speculation that there may be a second wave and there is the suggestion that the disease will become a seasonal disease. It is therefore imperative that random screening for SARS-CoV-2 (COVID-19) continues even after the first wave of the disease subsides so that we can monitor for its re-emergence. Our ERT-PCR is best suited for this purpose because it allows for sample pooling and detection of low viral loads.”
The test for SARS-CoV-2 that PharmaCyte licensed from Hai Kang Life was developed when Professor Yu and his team re-examined the same technology and methods that were used when they developed the successful test for the original SARS-CoV (SARS) virus and found that the test is also applicable to the new coronavirus. It’s a test that was published in The New England Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJM200404083501523) after it proved to be more sensitive, reliable, and accurate in detecting the SARS virus during the 2002-2003 outbreak in China.
To read the “Roadmap to Pandemic Resilience” visit: https://ethics.harvard.edu/files/center-for-ethics/files/roadmaptopandemicresilience_updated_4.20.20_0.pdf