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BioWorld - Saturday, January 17, 2026
Home » Topics » North America » U.S.

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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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Coronavirus, question marks

Bad info, delusions about testing fuel COVID-19 viral spiral

April 8, 2020
By Randy Osborne
Evercore ISI assembled a dozen internal specialists for a webinar to talk about COVID-19 from a variety of perspectives, with opinions aplenty on transmission route, up-and-coming treatment prospects, and problems in how testing procedures are understood – or not.
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Coronavirus vs U.S. wrecking balls

Device makers must tread carefully regarding regulatory, legal matters even during COVID-19

April 7, 2020
By Mark McCarty
The U.S. FDA has granted several emergency use authorizations (EUAs) to address the COVID-19 pandemic, a series of actions designed to lower regulatory hurdles. Despite these developments, the agency is keeping a close eye on issues, such as product claims, and both federal and state agencies are in a position to prosecute for hoarding and price gouging.
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Scientific data illustration
It’s not FAIR!

Accelerated by COVID-19, science changes will outlast pandemic

April 7, 2020
By Anette Breindl
COVID-19 has disrupted science in the way it has disrupted everything else. In the short term, universities have largely closed shop as a way to maximize social distancing, and lots of science – or at least, lots of bench work – is not getting done.
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Empty prescription drug bottle

Drug shortages worsen in gnarl of regulatory, logistics tangles

April 7, 2020
By Mari Serebrov
As the demand increases for ventilators to treat Americans with severe symptoms of COVID-19, another shortage is being exacerbated – a shortage of the drugs needed to treat patients on ventilators.
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Coronavirus headlines

Despite boost to telehealth, COVID-19 taking bite out of device utilization

April 6, 2020
By Mark McCarty
The emergence of the new variety of coronavirus has had a massive effect on medical care across the globe, which has boosted telehealth coverage while suppressing non-emergency procedures. Several medical societies have published guidelines for procedures during the COVID-19 outbreak, however, which in the aggregate suggest that many procedures will be significantly delayed.
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4-3-dunwoody-3d-shields.png

3D printing community rallies to meet hospitals’ needs in pandemic

April 3, 2020
By Meg Bryant
As health care workers face critical shortages of personal protective equipment (PPE) to deal with the COVID-19 crisis, 3D printing companies, medical device manufacturers and other organizations are stepping up to produce face shields, ventilators and other needed supplies. For its part, Rehovot, Israel-based Stratasys Ltd. has assembled a coalition of more than 150 companies and universities to produce 3D-printed visors and clear plastic face shields. The coalition aims to produce up to 16,000 face shields per week by the end of next week.
Read More
Scientific data illustration
It’s not FAIR!

Accelerated by COVID-19, science changes will outlast pandemic

April 3, 2020
By Anette Breindl
COVID-19 has disrupted science in the way it has disrupted everything else. In the short term, universities have largely closed shop as a way to maximize social distancing, and lots of science – or at least, lots of bench work – is not getting done.
Read More
Patent gears

PTAB affirms Becton case standard will be used to evaluate IPR petitions

April 2, 2020
By Mark McCarty
The U.S. Patent Trial and Appeal Board (PTAB) determined it would not take an inter partes review petitioned by Advanced Bionics Inc., in a patent dispute with Med-El Elektromedizinische. The precedential PTAB decision notes that it had invoked a two-step process for declining to take the petition as seen in a patent dispute involving Becton Dickinson and Co., and affirming that this will be the standard for addressing prior art in such appeals going forward.
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