Unprecedented Global Events Lead Diagnostic Providers to Innovative Breakthroughs

NEW YORK, Sept. 14, 2020 /PRNewswire/ -- As the pandemic continues to spread throughout the U.S., the need for testing is on the rise as well. Nevertheless, many states and regions are experiencing a shortage of tests, which is a serious obstacle in the fight against the spread of the viral infection, COVID-19. 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; yet 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. In New York, Governor Andrew Cuomo announced last week that a record number of tests were performed statewide on Friday, indicating that 102,925 test results were performed on in one day with a statewide infection rate of 0.82%. Cuomo explained that the "record-high number of tests helps the state make informed decisions to protect the welfare of New Yorkers, and helps them make informed decisions for themselves. But testing alone isn't enough, and we need residents to continue to wear masks, socially distance and wash their hands." Todos Medical Ltd. TOMDF, Aytu BioScience, Inc. AYTU, Co-Diagnostics, Inc. CODX, OPKO Health, Inc. OPK, Dynavax Technologies Corporation DVAX

The high demand for tests put the diagnostics test manufacturing industry under immense pressure. The sudden global need for accurate, high-quality testing is unlike anything it has experienced before. 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."

Todos Medical Ltd. TOMDF announced breaking news last week that, "the U.S. Food and Drug Administration (FDA) has added the TODOS 2019-nCoV RT-qPCR Detection Kit to its Notified List under the Emergency Use Authorization program. Todos is required to submit an Emergency Use Authorization application to the FDA within 15 days of submission of the notification. 

The Todos test is currently authorized to use only the QuantStudio 12Flex Instrument as a platform to perform the RT-PCR assay. It is estimated that there are more than 1,000 QuantStudio 12Flex Instrument installations in United States. The Company anticipates first shipments of test kits for existing CLIA laboratory clients to begin next week and will be working with those existing clients to complete validations on additional RT-PCR instruments to expand the commercial reach of the Todos test to include additional RT-PCR instruments. The Company currently has access to sufficient raw materials to manufacture approximately 1,000,000 test kits per week and is expanding its warehouse and logistics capabilities to meet an expected surge in demand in the weeks ahead given the testing market's desire for a highly accurate and analytically stable COVID-19 qPCR test. The Todos test instructions for use (IFU) include use of Todos proprietary ANDis 350 extraction system and extraction reagents that ensure consistency in the RNA extraction and purification process prior to RT-PCR analysis for virus detection.

'We are excited to make our highly sensitive RT-PCR test kits available in the United States as we continue to see spikes in COVID diagnoses in multiple areas,' said Gerald Commissiong, Todos Medical's President & CEO. 'We have taken a thoughtful and measured approach to addressing our nation's COVID-19 testing bottlenecks, including a shortage of equipment, personnel and reagents, and will now begin to work on reducing lengthy turnaround times for results that often leads to questionable accuracy by focusing on our mobile lab initiatives. These initiatives have been making great strides in the last several weeks and will serve as a new distribution channel for our products.'

'Our goal is to be a one-stop solution for all COVID testing including PCR tests, antigen tests, antibody tests and our proprietary 3C protease rapid test, as Todos begins to play a more prominent role in addressing the global COVID-19 crisis,' Mr. Commissiong continued. 'With the full validation of our Todos branded COVID-19 test kits now complete and submissions to FDA ongoing, we are currently validating our proprietary COVID + flu A/B test and intend to submit it to the FDA. Todos is positioning itself as a science-focused leader in the COVID-19 space that will stay at the forefront of the science and medical need in order to provide intelligent solutions that address the key challenges emerging worldwide.'

For information related to Todos Medical's COVID-19 testing capabilities, please visit www.todoscovid.com

For our latest "Buzz on the Street" Show featuring Todos Medical Ltd. recent corporate news, please head over to: https://www.youtube.com/watch?v=msW5MbyH5Bs

Aytu BioScience, Inc. AYTU reported earlier last week that it had signed an agreement to distribute the Pinnacle CovID RAD Rapid Antigen Detection Test worldwide. The rapid antigen test, which delivers results in fifteen minutes, tests for the presence of the SARS-CoV-2 virus antigen via a nasopharyngeal sample and can be conducted without the use of laboratory equipment. Pinnacle IVD Corporation plans to scale U.S. manufacturing capacity for the CovID RAD Rapid Antigen Detection Test to 25 million tests per month. The CovID RAD Rapid Antigen Detection Test was developed by U.S.-based Pinnacle IVD Corporation, a leader in colon cancer screening and other in-vitro diagnostics. The Pinnacle CovID RAD Rapid Antigen Detection Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2 in nasopharyngeal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider.

Co-Diagnostics, Inc. CODX announced last week that it had entered into an agreement with Arches Research, Inc, a CLIA laboratory and subsidiary of Polarity TE, Inc, PTE, to expand Arches' COVID-19 testing services using Co-Diagnostics' Logix Smart™ COVID-19 test kit. Dwight Egan, CEO of Co-Diagnostics, remarked, "We are pleased to have this opportunity to further expand our relationship with one of our valued CLIA lab clients to help meet demand for COVID-19 testing. Arches has been an important customer in the ongoing battle against the coronavirus, and we expect this agreement will also create opportunities for sales of additional molecular diagnostic products in our development pipeline, including our upcoming Logix Smart Flu A/Flu B/COVID-19 test kit."

OPKO Health, Inc. OPK announced back in July 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 20th, 2020, and is ongoing through November 19th, 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."

Dynavax Technologies Corporation DVAX reported last month that a grant from the Bill & Melinda Gates Foundation of USD 3.4 Million to scale up production batch size to allow for increased capacity of Dynavax's CpG 1018 advanced adjuvant to support the global COVID-19 response. These efforts will support capacity of up to 750 million adjuvant doses annually, which can be further increased if needed. "We are honored to receive this funding from the Bill & Melinda Gates Foundation to support development of a much-needed vaccine for COVID-19. This grant facilitates scale up of production capacity to ensure the availability of CpG 1018 for collaboration partners developing adjuvanted vaccines for COVID-19," commented Ryan Spencer, Chief Executive Officer of Dynavax. "We believe adjuvants will play an important role in developing effective vaccines for COVID-19, including for those patients at greatest risk for severe disease. The ability of CpG 1018 to potentially provide an improved immune response and also reduce the amount of vaccine antigen necessary will help provide more vaccine doses to meet the global need."

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