Associated tags: Laboratory, COVID-19, Blood, Privacy, Conference, Somatosensory system, Labcorp, POC, System, Pregnancy, FDA, Weigle, Health, Food, OTC, Infection, CDC, Classification, Syphilis, Pharmaceutical industry
Locations: UNITED STATES, NORTH AMERICA, ARKANSAS, WILLIAM, BS, PENNSYLVANIA, PHILADELPHIA, EUA, BARDA, CANADA
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Management NOWDiagnostics ( NOWDx ), a developer of over-the-counter (OTC) and point-of-care (POC) diagnostics tests and first-in-class technology and platforms, today announced the appointment of Dr. Stephen S. Tang, Ph.D., MBA, as the chairman of the company’s board of directors.
Key Points:
- NOWDiagnostics ( NOWDx ), a developer of over-the-counter (OTC) and point-of-care (POC) diagnostics tests and first-in-class technology and platforms, today announced the appointment of Dr. Stephen S. Tang, Ph.D., MBA, as the chairman of the company’s board of directors.
- View the full release here: https://www.businesswire.com/news/home/20240321747977/en/
NOWDiagnostics (NOWDx) Welcomes Dr. Stephen S. Tang as Chairman of the Board (Photo: Business Wire)
Dr. Tang is a longtime veteran of the medical diagnostic industry.
- He led OraSure Technologies, Inc. (NASDAQ: OSUR ), a pioneer and global leader in rapid at-home tests for HIV and COVID-19, for ten years as president and CEO, chairman of the board of directors, and chairman of the compensation committee.
- “I am delighted and enthusiastic about joining the NOWDx team as their chairman of the board,” said Dr. Tang.
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Pharmaceutical industry NOWDiagnostics (NOWDx) today announced the appointment of Jody Douglas Berry, Ph.D. as chief scientific officer (CSO).
Key Points:
- NOWDiagnostics (NOWDx) today announced the appointment of Jody Douglas Berry, Ph.D. as chief scientific officer (CSO).
- Dr. Berry, a distinguished scientific leader with over two decades of experience in infectious diseases, brings a wealth of expertise in diagnostics and therapeutics to the role.
- A recognized international expert in immunoassay development, antibody technology, and infectious diseases, Dr. Berry has over two decades of commercial, government and academic experience.
- Dr. Berry earned international recognition for his contributions to immunoassay development, antibody technology, and protein design.
Privacy,
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Pharmaceutical industry SPRINGDALE, Ark., Jan. 9, 2024 /PRNewswire/ -- NOWDiagnostics (NOWDx), a developer of over-the-counter (OTC) and point-of-care (POC) diagnostics tests and first-in-class technology and platforms, today announced they have submitted a De Novo Classification Request to the U.S. Food and Drug Administration (FDA) for the company's First to Know™ at-home syphilis test. Additionally, the company secured a strategic investment from the Labcorp Venture Fund, marking an important milestone in the company's commercialization strategy.
Key Points:
- Additionally, the company secured a strategic investment from the Labcorp Venture Fund , marking an important milestone in the company's commercialization strategy.
- NOWDx develops and manufactures "Touch to Test" OTC and point-of-care diagnostic tests that yield results in minutes.
- The development of the First to Know™ syphilis test comes as healthcare experts agree there is a syphilis emergency in the U.S., according to the Centers for Disease Control and Prevention ( CDC ).
- "We are excited about the FDA submission as we work to bring this syphilis test to market.
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Glycoproteins,
Clinical trials,
Spike protein,
COVID-19,
Antibody,
ZF2001 The ADEXUSDx COVID-19 antibody test detects antibodies that bind to the receptor binding domain (RBD) subunit of the S1 spike protein of the SARS-CoV-2 virus.
Key Points:
- The ADEXUSDx COVID-19 antibody test detects antibodies that bind to the receptor binding domain (RBD) subunit of the S1 spike protein of the SARS-CoV-2 virus.
- The most protective antibodies develop against this portion of the spike protein S1 domain and are induced by vaccination.
- The APhA Foundation is affiliated with the American Pharmacists Association, the oldest and largest national professional society of pharmacists in the United States established in 1852.
- The ADEXUSDxCOVID-19 Test will be distributed by C19 Development, LLC, a wholly owned subsidiary of NOWDiagnostics.
Chemical engineering associate professor Shannon Servoss, a former member of the ADEXUSDx COVID-19 antibody test development team at NOWDiagnostics, is the co-principal investigator, along with Shengfan Zhang, associate professor of industrial engineering.
Key Points:
- Chemical engineering associate professor Shannon Servoss, a former member of the ADEXUSDx COVID-19 antibody test development team at NOWDiagnostics, is the co-principal investigator, along with Shengfan Zhang, associate professor of industrial engineering.
- The objective is to test each enrollee three times over a period of four months.
- Secondly, it assists NOWDiagnostics in understanding the performance of their innovative antibody test and, very importantly, this study gives our talented team of undergraduate researchers experience in clinical research it really is a triple win."
- The ADEXUSDxCOVID-19 Test will be distributed by C19 Development, LLC, a wholly owned subsidiary of NOWDiagnostics.
Performance of the test does not require a phlebotomist, buffers, reagents, or additional equipment.
Key Points:
- Performance of the test does not require a phlebotomist, buffers, reagents, or additional equipment.
- The application to use the ADEXUSDxCOVID-19 Test for moderate complexity testing was originally submitted to the FDA in May 2020.
- Point of care (CLIA Waiver) performance data were subsequently submitted to the FDA in November 2020 to expand the use of the test.
- Additionally, the ADEXUSDx COVID-19 antibody test targets antibodies to the spike protein of the SARS-CoV-2 virus, positioning it to provide important utility in a post-vaccination world.
Medicine,
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COVID-19 testing The antibody test delivered 100 percent sensitivity and 100 percent specificity in a well-characterized 45 sample panel of COVID-19 positive and negative patient samples, provided by the Biodefense and Emerging Infections Research Resources Repository (BEI Resources) panel.
Key Points:
- The antibody test delivered 100 percent sensitivity and 100 percent specificity in a well-characterized 45 sample panel of COVID-19 positive and negative patient samples, provided by the Biodefense and Emerging Infections Research Resources Repository (BEI Resources) panel.
- The test can be usedacross a variety of health care settingsfrom hospital emergency rooms to clinicsand ultimately, by consumers for at-home use.
- As part of this cost-sharing contract, BARDA recommended evaluation of the ADEXUSDx COVID-19 antibody test with the BEI panel.
- NOWDiagnostics submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the test on May 29, 2020.
The COVID-19 rapid antibody test, using NOWDiagnostics' self-contained ADEXUSDx platform, requires no additional materials (reagents and buffers), equipment, processing, or refrigeration.
Key Points:
- The COVID-19 rapid antibody test, using NOWDiagnostics' self-contained ADEXUSDx platform, requires no additional materials (reagents and buffers), equipment, processing, or refrigeration.
- This can include those who have been recently or previously infected with COVID-19, regardless of whether they presented with severe, moderate, mild or no symptoms.
- Availability of point-of-care (POC) and over-the-counter (OTC) tests would allow individuals to be screened easily and quickly, yielding test results in minutes instead of days.
- By eliminating the need to send tests to off-site laboratories, NOWDiagnostics products have the potential to decrease the waiting period to determine test results from days to minutes.
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Truck driver The acquisition allows Truckstop.com to offer a full suite of payment services to carriers and positions the company as an industry leader in the transportation payments area.
Key Points:
- The acquisition allows Truckstop.com to offer a full suite of payment services to carriers and positions the company as an industry leader in the transportation payments area.
- With his leadership skills, we'll keep finding ways to increase efficiencies and reduce costs for each stakeholder in the transportation industry."
- He also served as CEO of Accelerated Payment Technologies which provides integrated payment technology to hundreds of independent software vendors.
- About D&S Factors D&S Factors specializes in factoring for truck drivers and others in the transportation industry.
