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BioWorld - Tuesday, May 19, 2026
Home » Topics » Diagnostics, BioWorld

Diagnostics, BioWorld
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Patient given oral swab

Support for human challenge trials gaining traction to accelerate COVID-19 vaccine work

May 11, 2020
By Nuala Moran
LONDON – Support is growing for human challenge trials in COVID-19 to be approved in order to speed up development of effective vaccines against the pandemic infection.
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Japanese shield and coronavirus

Japan advances fight against COVID-19 with four-day approval for remdesivir

May 8, 2020
By Alfred Romann and Gina Lee
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
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DNA, dollars illustration

Grail’s cancer liquid biopsy test gets $390M boost from series D round

May 7, 2020
By Meg Bryant
Liquid biopsy startup Grail Inc., of Menlo Park, Calif., has reeled in $390 million in a series D financing that included new investors Public Sector Pension Investment Board and Canada Pension Plan Investment Board. Prior investor Illumina Inc., of San Diego, also participated in the round, as well as two unidentified backers.
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Adam Buchanan, Geisinger Genomic Medicine Institute
AACR 2020

First prospective peek at Thrive’s Cancerseek reveals gaps in liquid biopsy testing

April 28, 2020
By Cormac Sheridan
DUBLIN – Thrive Earlier Detection Corp. and its academic and clinical collaborators have provided a first glimpse at the utility of a liquid biopsy test as a screening tool for picking up cancers in an asymptomatic population. In an interim one-year readout of data from the prospective five-year DETECT-A study in 10,000 women, an early version of Thrive’s Cancerseek test picked up 26 cancers ahead of standard-of-care screening, while the latter modality picked up another 24 cancers that Cancerseek missed.
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Patent law book and gavel

Undermining Bayh-Dole not the way to fight COVID-19

April 27, 2020
By Mari Serebrov
Given all the public-private partnerships responding to the need for timely COVID-19 therapies, diagnostics and vaccines, the demands to forgo patents or exclusive licenses for coronavirus products and the clamor that industry shouldn’t “profit” from U.S. taxpayer-supported research are growing louder.
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Earth threatened by virus

‘Speed and scale never before contemplated,’ as many world leaders back WHO on COVID-19 effort

April 24, 2020
By Nuala Moran
LONDON – The World Health Organization (WHO) launched a global collaboration to accelerate development and production of COVID-19 vaccines, therapeutics and diagnostics, with leaders of countries around the world appearing live to pledge their support.
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Respiratory infection

FDA’s Stenzel: EUA for COVID-19 home collection sample kit will happen ‘very soon’

April 15, 2020
By Mark McCarty
An April 15 U.S. FDA stakeholder call revisited several themes of interest in connection with diagnostics for the COVID-19 pandemic. However, Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health, said that while the agency has not yet authorized a home sample collection kit, “we do think it’s going to happen very soon.”
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Microscope image of SARS-CoV-2

Test makers, FDA struggling with shift from molecular to serology testing for SARS-CoV-2

April 14, 2020
By Mark McCarty
The age of molecular testing for the COVID-19 pandemic is still with us, but the emphasis in the months ahead will be on serological testing as a quicker, more useful mass testing alternative. However, test developers have a number of hurdles to overcome in devising these serological tests, including that antibodies for the virus’s antigens emerge at different times in the disease cycle, just one of several challenges that have to be met in the effort to bring the SARS-CoV-2 virus to heel.
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4-13-Chembio-Stony-Brook.png

Stony Brook, Chembio Diagnostics partner on COVID-19 trial

April 13, 2020
By Meg Bryant
Stony Brook Medicine has launched an FDA-approved, randomized investigational new drug (IND) trial to determine whether plasma from people who have recovered from COVID-19 can aid in the recovery of patients currently fighting the disease. Chembio Diagnostics Inc.'s COVID-19 rapid serological point-of-care test will be used to identify potential plasma donors.
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VIA Thaw system by Cytiva

Newly renamed Cytiva retains heart of GE Healthcare’s biopharma manufacturing unit

April 13, 2020
By Nuala Moran
LONDON – These are hardly times for a fanfare, but this month saw the unveiling of a new name in bioprocessing, following the formal closing of the $21.4 billion sale of GE Healthcare’s Life Sciences to Danaher Corp. The business, now renamed Cytiva, has turnover of $3.3 billion, nearly 7,000 employees and operations in 40 countries. More than 75% of FDA-approved biologic drugs use its products in their manufacture.
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