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BioWorld - Sunday, December 21, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Person holding knee, joint pain

Plan with the golden arm deals Navidea phase II imaging win in RA

May 22, 2020
By Randy Osborne
Navidea Biopharmaceuticals Inc. CEO Jed Latkin said positive findings from the second interim analysis of the phase IIb study called NAV3-31 “were certainly better than what we were looking for” and will “make our partnering discussions a lot more interesting.”
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Drug capsules, broken chain over world map

Pandemic leaves no room for weak link in the supply chain

May 22, 2020
By Mari Serebrov
Scaling up to manufacture a massive volume of a COVID-19 vaccine, drug or innovative device that’s still in early stage development is easier said than done, especially in a global pandemic that has the supply chain stretched beyond capacity.
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3D illustration of virus with RNA inside

Mammoth Biosciences, GSK team up on CRISPR-based COVID-19 test

May 22, 2020
By Meg Bryant
Mammoth Biosciences Inc., of South San Francisco, and London-based Glaxosmithkline plc (GSK) have joined forces to develop a point-of-care test to detect active COVID-19 infections using Mammoth’s CRISPR-based DETECTR platform. The two companies hope to submit an application to the U.S. FDA for emergency use of the test before the end of the year.
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Navidea reports second interim analysis from phase IIb study of Tc99m tilmanocept imaging in RA

May 22, 2020
3D illustration of virus with RNA inside

Mammoth Biosciences, GSK team up on CRISPR-based COVID-19 test

May 21, 2020
By Meg Bryant
Mammoth Biosciences Inc., of South San Francisco, and London-based Glaxosmithkline plc (GSK) have joined forces to develop a point-of-care test to detect active COVID-19 infections using Mammoth’s CRISPR-based DETECTR platform. The two companies hope to submit an application to the U.S. FDA for emergency use of the test before the end of the year.
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Early cavity detection (ECD) system product image

Ortek fills cavity in dental care with early caries detection system

May 21, 2020
By Annette Boyle
Ortek Therapeutics Inc., of Roslyn Heights, N.Y., has officially launched its electronic early cavity detection system, the Ortek-ECD. The U.S. FDA-cleared device can detect dental lesions before they show up on X-rays, enabling less invasive treatment and preventing greater damage to the tooth structure. Ortek holds the exclusive license for the device which was developed at Stony Brook University School of Dental Medicine.
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Lungs, COVID-19 test tube, health care worker in PPE

Israel’s Ben-Gurion University develops one-minute coronavirus test

May 21, 2020
By David Ho
HONG KONG – A researcher at Israel’s Ben-Gurion University of the Negev (BGU) has developed a test that identifies those carrying the COVID-19 virus in less than a minute. And it is both affordable and works with greater than 90% accuracy to boot.
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BioWorld MedTech’s Diagnostics Extra for May 21, 2020

May 21, 2020
By Meg Bryant and Anette Breindl
Keeping you up to date on recent developments in diagnostics, including: Deep learning algorithm helps to differentiate TBI lesions; Methylation markers in HPV-associated head and neck cancer; The World According to GARP.
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Antibodies fighting coronavirus

Abcellera awarded CA$175.6M to identify COVID-19 antibodies, boost pandemic manufacturing solutions

May 20, 2020
By David Godkin
TORONTO – How confident is Canada’s government that Abcellera Biologics Inc. can identify viral antibodies to help stop COVID-19 in its tracks and build the manufacturing infrastructure for antibody therapies against future pandemic threats? Enough to award the Vancouver, British Columbia-based biotech CA$175.6 million (US$124.7 million) for the application of its antibody discovery platform to the analysis of patients who have recovered from COVID-19.
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FDA’s Stenzel: Abbott agrees to new study for ID Now test for COVID-19

May 20, 2020
By Mark McCarty
The FDA’s response to the COVID-19 pandemic has been matched by device makers, but the ID Now molecular test by Abbott Park, Ill.-based Abbott Laboratories has been the target of recent criticism. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, said at a May 20 town hall meeting that Abbott has agreed to yet another study of the ID Now, the terms of which were under negotiation at the time of the meeting.
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