Point of Care Testing Essential for Preventing Spread Of Coronavirus in U.S.

PALM BEACH, Florida, Jan. 29, 2020 /PRNewswire/ -- In 2011, the National Academies Of Sciences, Engineering and Medicine published a report entitled: "Evaluating Systems for the Early Detection of Biological Threats (abbreviated version)". They were prophetic in saying that the initial contact with an individual patient at their initial point-of-entry is key to preventing widespread outbreaks, and to proper treatment of the individual subject. The report read in part: "The development and appropriate use of rapid, multiplexed "point-of-care" diagnostic tests seem likely to strengthen both surveillance and bedside patient care by helping clinicians pinpoint the cause of an infection… In theory, the availability and use of validated multiplex point-of-care bioassays at frontline acute and primary care clinical settings would allow clinicians to test patients in response to public health alerts for persistent and seasonal pathogens, as well as bioterrorism agents and other pathogens of potentially great public health significance (e.g., avian influenza, SARS)… Advances in IT make it possible to collect and analyze public health information more quickly, accurately, and comprehensively than is possible with traditional manual methods. IT can greatly ease the demands of reporting…" Active companies in the markets this week include Hawkeye Systems, Inc. (OTCQB: HWKE), NanoViricides, Inc. (NYSE: NNVC), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Novavax, Inc. (NASDAQ: NVAX), Meridian Bioscience, Inc. (NASDAQ: VIVO).

Well, since 2011 the diagnostic world has indeed been making strides in that exact direction. A recent article/interview on CNBC with Dr. Scott Gottlieb, a resident fellow at the American Enterprise Institute, Pfizer board member and the former commissioner of the FDA. He added: "When pockets of the outbreak arrive on our shores, we shouldn't have undue panic. But we need to be ready. The most important public health measures to contain new outbreaks are the early identification and isolation of cases to prevent further spread. Key to applying these measures and limiting spread will be easy access to reliable and rapid diagnostic tests to enable widespread screening. These tools will allow us to identify new cases early and isolate sick individuals.   Dr. Gottlieb continued: "We need to adapt technologies that can allow testing right at the point of care. These kinds of rapid diagnostics exist for diseases like influenza. In the case of flu, a nasal swab is used to make a rapid diagnosis in the doctor's office, where the strip test offers physicians a readable output. These same technologies can be tailored to coronavirus."

Hawkeye Systems, Inc. (OTCQB: HWKE) NEWS:  Hawkeye's Body Cam Platform Represents Evolutionary Progress for Field Level Biosurveillance - Hawkeye Systems is pleased to announce the creation of a strong body cam platform for biosurveillance and real-time monitoring of issues such as the Coronavirus.

"It's the personnel at the front line that are likely to be exposed first so our thought was why not build in the functionality to give early warning and early detection, not as an afterthought or reactively, but proactively in the platform," said Corby Marshall, CEO of Hawkeye Systems. "With power and data at the harness point, coupled with the ability to provide real-time connectivity via 5G, the opportunities are limitless."

With the addition of plug and play modules and interoperability with different sensor types, the [In-Depth] Body Cam platform has the ability to collect and monitor data related to bio-hazards and possible public health issues. Read this full press release and more HWKE here:  https://www.financialnewsmedia.com/news-hwke/

Other recent developments in the tech industry markets this week include:

NanoViricides, Inc. (NYSE: NNVC) recently announced that it has successfully completed genetic toxicology testing required to support the IND application for NV-HHV-101 moving towards human clinical trials.  NV-HHV-101 was found to be safe in terms of potential genotoxicity in the suite of tests that were performed by an independent laboratory. The drug did not induce mutations in bacteria and did not cause chromosomal damage in human cells.

In the Ames test, NV-HHV-101 was negative for the ability to induce mutations in genes of several strains of Salmonella typhimurium and of Escherichia coli, both in the presence and absence of an exogenous metabolic activation system. The Ames test is used to assess the direct ability of a drug to cause mutations in DNA or genes, using bacterial cells.

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) recently announced the Coalition for Epidemic Preparedness Innovations (CEPI) has awarded Inovio a grant of up to $9 million to develop a vaccine against the recently emerged strain of coronavirus (2019-nCoV). This initial CEPI funding will support Inovio's preclinical and clinical development through Phase 1 human testing of INO-4800, its new coronavirus vaccine matched to the outbreak strain. CEPI previously awarded Inovio a grant of up to $56 million for the development of vaccines against Lassa fever and Middle East Respiratory Syndrome (MERS), also caused by a coronavirus.

Inovio's participation in this developing effort is based on the ideal suitability of its DNA medicine platform to rapidly develop a vaccine against an emerging virus with pandemic potential, proven vaccine development capabilities and a strong track record of rapidly generating promising countermeasures against previous pandemic threats.

Novavax, Inc. (NASDAQ: NVAX) recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M™, in adults 65 years of age and older.

"The FDA's decision to grant Fast Track Designation for NanoFlu reflects the urgent unmet medical need for a more effective vaccine against influenza, particularly in the older adult population which often experiences serious and sometimes life-threatening complications, of the disease" said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We believe that NanoFlu will offer an innovative improvement compared to traditional egg-based vaccines, which frequently result in mismatch and poor effectiveness. We look forward to working closely with the FDA through the expedited review process, accelerating the access to this vaccine for the most vulnerable populations."

Meridian Bioscience, Inc. (NASDAQ: VIVO) recently announced a novel coronavirus, identified by Chinese authorities on January 7 and currently named 2019-nCoV, is a new strain that had not been previously identified in humans. The outbreak started on the Chinese city of Wuhan, 56 people have already died and more than 2,000 confirmed infected. This new virus has already spread to other parts of mainland China and several other countries and health authorities around the world are taking action to prevent a global epidemic.

The World Health Organization (WHO) has provided interim guidance to laboratories and stakeholders involved in laboratory testing of patients who meet the definition of suspected case of pneumonia associated with 2019-nCoV. Sequence information from the 2019-nCoV has recently been made available and diagnostic companies and laboratories in China have turned to Meridian's Lyo-Ready 1-Step RT-qPCR Mix to develop fast and accurate screening assays. Meridian's manufacturing team is working diligently to meet the supply of critical reagents for the detection of Coronavirus and fast response to the outbreak.

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