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Home » SARS-CoV-2

Articles Tagged with ''SARS-CoV-2''

Regulatory front for April 9, 2020

April 9, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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SARS-CoV-2 molecular diagnostic
Diagnostics

The next pandemic: Excess testing capacity essential, but cost question not yet answered

April 8, 2020
By Mark McCarty
There will be lessons learned aplenty when the COVID-19 pandemic finally breaks, including how serological and molecular testing can be used to maximum effect to corral a future pandemic. Carmen Wiley, president of the American Association of Clinical Chemistry, told BioWorld that the existing instrument types are up to the job, but that surge capacity is needed, and that it is not clear how the cost of that capacity will be handled.
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Coronavirus and DNA

Genmark boosts full-year guidance as Eplex placements rise

April 8, 2020
By Liz Hollis
Amid the COVID-19 pandemic, Genmark Diagnostics Inc., of Carlsbad, Calif., has offered a preliminary look at its first-quarter results. And it is forecasting hopeful news, increasing its full-year guidance to a range of $112 million to $122 million. That's up from a previous prediction of $100 million to $110 million.
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Regulatory front for April 8, 2020

April 8, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: General Motors, Inbios International, Philips, Ventec Life Systems.
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Drug vial and syringe
Toward breathing easier

Novavax coronavirus vaccine, Bellerophon COVID-19 therapy near phase I

April 8, 2020
By Michael Fitzhugh
Novavax Inc., one of the first biopharma companies to reveal its efforts to develop a SARS-CoV-2 vaccine in January, has identified a prefusion protein for testing in an Australian phase I trial, slated to start in mid-May.
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4-7-Genetic-Signature-Easyscreen.png

Australia’s Genetic Signatures garners CE mark for its Easyscreen PCR COVID-19 diagnostic

April 7, 2020
By Tamra Sami
PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. received the CE mark for its 3base Easyscreen SARS-CoV-2 detection kit, clearing the way for marketing across the EU.
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Other news to note for April 7, 2020

April 7, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acumen Research Laboratories, Allurion Technologies, Almac Clinical Technologies, Artms Products, Beam Therapeutics, Bio-Rad Laboratories, Biotricity, Cure Pharmaceutical, Getinge, Imaginab, Invitae, Ivwatch, James Fisher, The Janz, Medipines, Mesa Biotech, Mirion, Nano-X, Oklahoma State University, Qure.ai, OGT, Parallax, Rapid Medical, United Global Alliance, Vortran, Xerox.
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Regulatory actions for April 7, 2020

April 7, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cochlear, Genetron, Gnomegen, Motus GI, Nitiloop, Orthosensor.
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BioWorld MedTech’s Oncology Extra for April 7, 2020

April 7, 2020
By Mark McCarty and Anette Breindl
Keeping you up to date on recent developments in oncology, including: Technetium crunch resurfaces as COVID-19 roils the globe; Microbiome changes precede tumor development in CRC; Il-27 proposed as target in prostate cancer.
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Regulatory front for April 7, 2020

April 7, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3M, Boston Scientific, Gnomogen, Viracor Eurofins Clinical Diagnostics.
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