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Developer of PharmaCyte’s COVID-19 Test Explains Why Test Is So Highly Sensitive, Path to FDA EUA, and Commercialization

NEW YORK, NY—PharmaCyte Biotech (OTCQB: PMCB) recently entered into a licensing agreement with Hai Kang Life Corporation (Hai Kang), where Hai Kang granted to PharmaCyte a license to the technology related to its COVID-19 diagnostic testing kits.  The inventor of that technology is no stranger to responding to worldwide outbreaks of infectious diseases.  He is the Founder and Chairman of the Hong Kong-based biotechnology company, Hai Kang, Professor Albert Cheung-Hoi Yu, Ph.D.  Under the leadership of Prof. Albert Yu, Hai Kang has been fast and accurate in responding to global infectious disease outbreaks, such as avian influenza, SARS, H1N1 influenza, and now the SARS-CoV-2 outbreak, the virus that causes the coronavirus disease (COVID-19).

Professor Albert Yu is a renowned neuroscientist and bio-entrepreneur who has devoted over two decades in neuroscience and infectious disease research, and he has had significant contributions to molecular neurobiology and molecular diagnosis.  Professor Yu is the Vice-Director of the Neuroscience Research Institute, Professor of the Department of Neurobiology, and also a Professor at the Infectious Disease Center at Peking University.

The professor is also the Director of the Asian Fund for Cancer Research and the Chairman of the Hong Kong Biotechnology Organization, and he agreed to talk to us about the tests that he and his team at Hai Kang have developed for SARS-CoV-2, a test he says is “the most sensitive in the world.”

Question 1: Explain the current virus testing landscape related to COVID-19?

Professor Yu: “There are two main testing methods; real-time PCR and antibody-based testing.  The real-time PCR tests detect viral nucleic acid (RNA) using primers and probes that specifically recognize target gene sequences in the virus genome.  Both manual and automatic variations are available.  Antibody-based methods detect host antibodies that are produced in response to the infection.  As well as tests that are done in laboratories, some antibody-based tests are point-of-care kits or even ‘home kits.’”

Question 2: What is the test that you and your team developed for COVID-19 or SARS-CoV-2, and how is it different from the test you previously developed during the SARS outbreak?

Professor Yu: “The test developed for detecting SARS-CoV-2 is the Enhanced Real-Time PCR (ERT-PCR) method.  The technology is the same as the previous test for SARS, but the primers and probes used in the current test is specific for the novel coronavirus.  This means test results are positive only if the SARS-CoV-2 target sequences are present in the test sample.”

Question 3: How do these tests work?

Professor Yu: “Routine RT-PCR methods utilize reverse-transcription plus TaqMan® real-time PCR using specific primers and probes.  Our ERT-PCR method, however, incorporates a reverse-transcription plus PCR step prior to TaqMan® real-time PCR.  The primers and probes target the ORF1ab and N genes of SARS-CoV-2.

“The two primer pairs for the first PCR step were designed to flank two regions larger than but encompassing the two flanked by the sets used for the second real-time PCR step.  After the first-round of amplifications, the amplicons act as a template for the second round of amplification such that the template for the real-time PCR step is dramatically increased.  This ensures that even very low amounts of SARS-CoV-2 target sequences could be detected, increasing the method sensitivity.”

Question 4: How is the test you developed superior to the other tests mentioned above?

Professor Yu: “Compared to the routine RT-PCR tests, our test is more sensitive.  Its limit of detection is down to 1-2 copies 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.

“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.

“Moreover, 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.”

Question 5: What is the path forward to get these test kits into the hands of consumers?

Professor Yu: “We are preparing to file for U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) approval with our US partner, PharmaCyte Biotech.  Once the test has FDA EUA, it will enter into production for commercialization.”

Question 6: Are your tests “home kits” or do they have to be administered by a doctor in a clinic/hospital setting?

Professor Yu: “The tests are not ‘home kits.’  Specimens can be collected at home using appropriate collection kits and strictly following the instructions for specimen collection.  Specimens whether collected at home or in a clinic/hospital setting are then sent to testing laboratories and the actual tests have to be done by trained personnel at the laboratory.”

Question 7: Explain why this test for COVID-19 is going to be necessary for much longer than the next few weeks/months?

Professor Yu: “It is expected that the first wave of COVID-19 will persist for the next few months.  There is speculation that there may be a second wave and there is suggestion that the disease will become a seasonal disease.  It is therefore imperative that random screening for SARS-CoV-2 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.”

To learn more about PharmaCyte Biotech visit: https://www.PharmaCyte.com and to learn more about Hai Kang Life visit: https://www.haikanglife.com/index.php/en/

About PharmaCyte Biotech

PharmaCyte Biotech, Inc. is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live-cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.

PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in little to no treatment-related side effects.

PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is developing the use of genetically modified liver cells and stem cells, as well as beta islet cells, to treat diabetes. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they will function as a “bio-artificial pancreas” for purposes of insulin production.

 

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