Innovative Diagnostic Kits Arise from a Time of Global Turmoil

NEW YORK, Aug. 13, 2020 /PRNewswire/ -- As healthcare systems come under severe pressure from the pandemic, significant changes to their infrastructure are needed and being implemented. In particular, effective and mass testing is necessary to ensure the strategies implemented to fight the pandemic are effective. As a result, significant changes have been made in the testing segment, as diagnostic testing has improved over the course of the last several months. By test type, the rapid antigen test is likely to hold substantial market share in 2020. Antigen assays are also usually more cost-effective when compared to either molecular or culture techniques. And, the global rapid test kit market for the viral pandemic is expected to reach USD 3.91 Billion by 2027, according to a new report by Reports and Data. AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC), Moderna, Inc. (NASDAQ: MRNA), Novavax, Inc. (NASDAQ: NVAX), Vir Biotechnology, Inc. (NASDAQ: VIR), Inovio Pharmaceuticals, Inc. (NASDAQ: INO).

The Food and Drug Administration (FDA) emphasized the importance of testing capabilities back in March. According to the FDA's announcement, it has issued the fourth diagnostic related Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath Combo Kit. FDA Commissioner Stephen M. Hahn, M.D explained that "We have been engaging with test developers and encouraging them to come to the FDA and work with us. Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process." Now, various companies from a vast field of industries, including pharmaceuticals, medical device innovators and others have all made various declarations regarding products or services related to the pandemic, with testing kits at the center of attention.

AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC) announced breaking news earlier this week that, "the Company has commenced operations of its new Philadelphia lab, with the completion of its facility renovation and first phase equipment installation in July 2020. A Roche Cobas e411 machine, a diagnostic analyzer, which has received the FDA's Emergency Use Authorization for performing COVID-19 anti-body tests, is among the Laboratory's first phase equipment.

'AnPac Bio plans to perform both cancer screening research on its CDA technology and offer for commercial purposes COVID-19 antibody tests using the Roche Cobas e411 machine once these tests have been respectively qualified and approved as per FDA regulations,' said Dr. Chris Yu, AnPac Bio's CEO. In addition, Dr. Yu explained that 'the Company's San Jose lab has been validating the COVID-19 anti-body test on Roche's Cobas e411 machine since the second quarter of 2020, and after the validation is completed in the second half of 2020, AnPac Bio will conclude any other regulatory approvals in order to begin commercial transactions.'

AnPac Bio's CEO, Dr. Chris Yu, further commented, 'The commencement in operations of our Philadelphia lab signals that AnPac Bio is entering into a new growth phase in the United States. Our significant patent portfolio (19 US issued patents to date), highly innovative cancer screening technology (Cancer Differentiation Analysis Technology (CDA)) and its sample size (> 180,000 samples), reputable medical institution partners, and now our bio-medical labs on both the East and the West coasts, will greatly contribute to our success in the US.'

About AnPac Bio: AnPac Bio is a biotechnology company focused on early cancer screening and detection, with 128 issued patents as of June 30, 2020. With two certified clinical laboratories in China and one CLIA and CAP accredited clinical laboratory in the United States, AnPac Bio performs a suite of cancer screening and detection tests, including CDA (Cancer Differentiation Analysis), bio-chemical, immunological, and genomics tests. According to Frost & Sullivan, AnPac Bio ranked third worldwide and first in China among companies offering next-generation early cancer screening and detection technologies in terms of the number of clinical samples for cancer screening and detection, based on approximately 41,700 clinical samples as at May 2020. AnPac Bio's CDA technology platform has been shown in retrospective validation studies to be able to detect the risk of over 20 different cancer types with high sensitivity and specificity.

For more information, please visit: https://www.Anpacbio.com

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Moderna, Inc. (NASDAQ: MRNA) announced this week that the U.S. government has secured 100 million doses of mRNA-1273 as part of the U.S. government's goal of securing early access to safe and effective COVID-19 vaccines for the American people. Today's award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. With the previous award of up to $955 million from BARDA for the development of mRNA-1273 to licensure, today's announcement brings the U.S. government commitments for early access to mRNA-1273 to up to $2.48 billion. Under the terms of the agreement, the U.S. government, as a part of Operation Warp Speed, will also have the option to purchase up to an additional 400 million doses of mRNA-1273 from Moderna. The U.S. government has announced that consistent with its commitment to free access to COVID-19 vaccines, Americans will receive mRNA-1273 at no cost for the vaccine itself. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine.

Novavax, Inc. (NASDAQ: NVAX) and Takeda Pharmaceutical Company Limited announced last week a partnership for the development, manufacturing and commercialization of NVX–CoV2373, Novavax' COVID–19 vaccine candidate, in Japan. NVX–CoV2373 is a stable, prefusion protein made using Novavax' recombinant protein nanoparticle technology and includes Novavax' proprietary Matrix–M™ adjuvant. Takeda will receive funding from the Government of Japan's Ministry of Health, Labour and Welfare (MHLW) to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year. "Takeda's leading position in Japan, technical expertise, regulatory know-how and manufacturing capacity make the company an ideal partner to further expand the global availability of NVX–CoV2373," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We look forward to collaborating with Takeda to rapidly develop, produce and commercialize the vaccine in Japan."

Vir Biotechnology, Inc. (NASDAQ: VIR) reported back in May that is has finalized a process development and manufacturing agreement with Biogen Inc. based on the letter of intent that the companies announced in March. Under the agreement Biogen will perform process development activities and specified manufacturing and process transfer services to enable commercial supply of Vir's SARS-CoV-2 monoclonal antibodies. "Biogen's world-class cell line and process development expertise is a tremendous asset as we work with great urgency to develop our antibody candidates, including employing technology that is designed to maximize the yield of each manufacturing batch produced," said Michael Kamarck, Ph.D., Chief Technology Officer of Vir. "The willingness of both Vir and Biogen to begin work before the definitive agreement was in place exemplifies our shared commitment to working in unconventional ways in the interest of the public good, and mutual recognition that bringing these therapies to people at the speed and scale that is needed requires the combined resources of multiple collaboration partners and significant manufacturing capacity."

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced back in June positive interim clinical data of INO-4800, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the first two Phase 1 clinical trial cohorts. In addition, INO-4800 has been selected to participate in a non-human primate (NHP) challenge study as part of the U.S. government's Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021. Furthermore, INOVIO has expanded its Phase 1 trial to add older participants in additional cohorts and plans to initiate a Phase 2/3 efficacy trial this summer upon regulatory concurrence. Dr. J. Joseph Kim, President and CEO of INOVIO, said, "INOVIO would like to thank all of the trial participants and the investigator staff who have made this trial possible. We are very encouraged by the positive interim safety and preliminary cellular and humoral immune response results to date as well as the inclusion of INO-4800 in Operation Warp Speed. We are also pleased that INO-4800 vaccination abrogated viral replication in the lungs of mice challenged with SARS-CoV-2. We look forward to urgently advancing INO-4800, as it is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not require to be frozen in transport or for years of storage, which are important factors when implementing mass immunizations to battle the current pandemic."

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