Improving Techniques Provide More Accurate Diagnostics

NEW YORK, Aug. 12, 2020 /PRNewswire/ -- As the pandemic continues to spread throughout the U.S., the need for testing is on the rise as well. But many states and regions are experiencing a shortage of tests, which is a serious obstacle to the fight against the spread of the viral infection. According to the report by the New York Times from back in July, at a testing site in New Orleans, a line formed at dawn. But city officials ran out of tests five minutes after the doors opened at 8 a.m., and many people had to be turned away. Overall, testing continues to be a very uneven, as some states have managed to provided higher rates of testing than others. The most common test, the nose swab, which is similar to various flu virus tests, are not always certain; if a test result comes back positive, it is almost certain that the person is infected. However, negative test result is less definite. An infected person could get a so-called "false negative" test result if the swab missed the virus, for example, or because of an inadequacy of the test itself. Antibody testing however, which requires a blood sample, is gradually becoming more available. AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC), Dynavax Technologies Corporation (NASDAQ: DVAX), Co-Diagnostics, Inc. (NASDAQ: CODX), Aytu BioScience, Inc. (NASDAQ: AYTU), OPKO Health, Inc. (NASDAQ: OPK)

The diagnostics test manufacturing industry is under immense pressure in recent times. The sudden global demand for accurate, high-quality testing is unlike anything the market has experienced before. Test makers are now tasked with scaling up production up from millions of tests per month to millions per week, and the material needed are not always available to achieve this goal. According to a report by Barron's, "To meet growing global demand, current test manufacturers and their supply chains need to continue investing to scale up production. That alone won't be enough. More companies need to start manufacturing tests. In the U.S. only a few companies have been granted FDA Emergency Use Authorization to sell rapid diagnostic tests, and most of these tests are manufactured offshore. Transferring the manufacturing technology for these high-quality tests to the U.S. and building up local manufacturing facilities would quickly increase the supply."

AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC) announced breaking news yesterday 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.

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Dynavax Technologies Corporation (NASDAQ: DVAX) and commercializing novel vaccines, and Medigen Vaccine Biologics Corporation (MVC) reported last month, their collaboration to develop an adjuvanted vaccine candidate to protect against COVID-19. The collaboration is evaluating the combination of MVC's stable prefusion form of the SARS-CoV2 recombinant spike protein with Dynavax's advanced adjuvant CpG 1018(TM), the adjuvant contained in Dynavax's U.S. FDA-approved adult hepatitis B vaccine. "The COVID-19 pandemic is straining healthcare systems across the globe, making a safe, effective and affordable vaccine an important tool in combatting the disease and protecting patients, especially for low and middle-income countries (LMICs)," said Charles Chen, Chief Executive Officer of Medigen. "In preclinical testing, the combination of Dynavax's proven adjuvant with our recombinant spike protein vaccine candidate generated strong virus neutralizing antibody responses and cellular immunity. These results support advancing evaluation of the combination into Phase 1 human testing, which we expect to begin in September of this year."

Co-Diagnostics, Inc. (NASDAQ: CODX) earlier in May announced the publication of a paper showing its Logix Smart(TM) COVID-19 Test Kit was used to demonstrate that the SARS-CoV-2 virus can be detected in cancer tissue of coronavirus patients, even before symptoms occur. The peer-reviewed paper, published in the Journal of Clinical Pathology, described a study performed at the European Institute of Oncology in Milan, Italy. Researchers used the Company's test to determine whether SARS-CoV-2 was present in the removed tumor of a man who later become symptomatic and was diagnosed with COVID-19. "We are pleased that the quality of our innovative Logix Smart COVID-19 test kit has been demonstrated once again by this impressive and important study," said Dwight Egan, Co-Diagnostics CEO. "Being able to detect the presence of the virus before symptoms even occur illustrates the sensitivity and value of our test, especially in new sample types. The world needs every advantage we can get in our battle against this deadly disease, and we believe our test has the attributes needed to benefit millions across the globe."

Aytu BioScience, Inc. (NASDAQ: AYTU) reported earlier last month that the Company has signed a distribution agreement with Apollo Med Innovations, Inc. ("Apollo") to distribute the COVID-19 IgG/IgM Rapid Test Cassette to Apollo's network of over 1,000 practices across the United States. This distribution relationship expands the Company's coverage of clinician and professional customers to a large network of medical clinics, clinical laboratories, and wellness centers. Apollo is also engaged with a growing number of employers and municipalities in offering their COVID-19 testing services. Through Apollo's introduction of innovative research-based COVID-19 testing protocols and their offering of comprehensive laboratory support services, this distribution relationship significantly expands the Company's COVID-19 potential user base. Through this relationship between the Company and Apollo, Apollo has begun to introduce the COVID-19 IgG/IgM Rapid Test Cassette as part of a comprehensive support program for professional medical organizations, integrated wellness centers, employers, and municipalities.

OPKO Health, Inc. (NASDAQ: OPK) announced last month that it will accept an Indefinite Delivery Indefinite Quantity (IDIQ) contract award to provide Commercial Surge Capacity Testing for COVID-19 Emergency Response to the Centers for Disease Control and Prevention (CDC). Under the contract with the CDC, BioReference will perform antibody testing to determine COVID-19 seroprevalence, and will provide results with key demographic information and analysis in collaboration with the CDC. The agreement's period of performance began July 20, 2020, and is ongoing through November 19, 2020. "Working with the CDC underscores the importance of public, private partnership to achieve a worthwhile COVID-19 response," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Many studies suggest that the majority of the public has not been infected with COVID-19, but multiple factors limit these findings. Together with the leading public health authority, we are leveraging extensive depth and breadth of testing expertise to increase overall understanding of the disease burden of the virus."

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