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BioWorld - Tuesday, February 3, 2026
Home » Topics » Medical technology » Diagnostics

Diagnostics
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COVID-19 IgG/IgM antibody test

Kahala Biosciences, Rymedi bring blockchain to COVID-19 antibody testing

May 27, 2020
By Meg Bryant
Widespread testing is going to be key to safely reopening businesses and global economies in the current pandemic. To that end, Kahala Biosciences LLC, an Irvine, Calif.-based testing and tracking startup, and its technology partner, Rymedi Inc., of Greenville, S.C., have launched the Adiona COVID-19 antibody testing platform, combining antibody testing with a blockchain-enabled smartphone app to increase predictability and traceability of potential outbreaks.
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FDA icons

U.S. FDA encouraging COVID-19 test developers to file 510(k)s

May 27, 2020
By Mark McCarty
The number of tests of various types for the SARS-CoV-2 virus are still growing, but the emergency use authorization (EUA) program is not the only option for developers. Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiology, said on the agency’s May 27 town hall that the agency would like to see test developers file for a 510(k) for their tests when the data are sufficient to support an application, adding that any such clearances will not affect the U.S. FDA’s interest in keeping plenty of similar tests on the market via the EUA mechanism.
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Antibodies fighting coronavirus

Abcellera raises $105M in series B, following Lilly collaboration and COVID-19 funding award

May 27, 2020
By David Godkin
Within a month of disclosing a CA$175.6 million (US$124.7 million) award from the Canadian government to use its antibody discovery platform for the analysis of patients who have recovered from COVID-19, Abcellera Biologics Inc. closed a $105 million series B financing aimed at expanding its capacity and investing in new technologies that complement its antibody discovery engine.
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DNA NGS genome sequencing

Roche snaps up sequencing startup Stratos Genomics

May 26, 2020
By Meg Bryant
Pharma and diagnostics giant Roche Holding AG, of Basel, Switzerland, has acquired Seattle-based Stratos Genomics Inc., an early-stage sequencing technology company, in a move aimed at advancing development of Roche’s nanopore sequencer. Financial terms of the deal, which was first reported on Friday, were not disclosed.
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U.S. Capitol building

U.S. HHS projects national daily COVID-19 testing needs at 300,000, but Democrats unimpressed

May 26, 2020
By Mark McCarty
The U.S. Department of Health and Human Services (HHS) has posted a national COVID-19 testing strategy in response to legislation passed in April, and the plan suggests that 300,000 tests per day should suffice to corral the pandemic. That calculation drew immediate fire from House and Senate Democrats, who characterized the plan as an attempt “to paint a rosy picture about testing,” but they also pushed the Senate to pass House legislation that would provide another $75 billion in funding for testing and contact tracing.
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Phase I/II trial evaluates LS-301 uptake in breast cancer patients

May 25, 2020

Fidget spinner allows point-of-care diagnosis of UTIs

May 25, 2020
U.S. FDA headquarters

FDA says 28 serology tests withdrawn or pulled from availability in the U.S.

May 22, 2020
By Mark McCarty
The U.S. FDA reported that 28 serology tests for antibodies for the SARS-CoV-2 virus either have been withdrawn from the market by the sponsor or delisted by the agency for failure to comply with its notification process for emergency use authorization (EUA). The agency said the list of unavailable tests will be updated over time. For his part, Commissioner Stephen Hahn said the move was undertaken “to ensure that Americans have access to trustworthy tests.”
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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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