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

Diagnostics
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Aerosolsense Sampler in waiting room

Thermo Fisher launches SARS-CoV-2 ambient air surveillance system

March 29, 2021
By Mary Ellen Schneider
Thermo Fisher Scientific Inc. has launched a surveillance system that can detect SARS-CoV-2 in ambient air in indoor spaces, providing a potential complement to individual testing and other COVID-19 safety protocols. The system, called the Aerosolsense Sampler, works by capturing a sample of the ambient air on a cartridge using Thermo Fisher’s collection substrate.
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IPO puzzle pieces

Somalogic to merge with CM Life Sciences II SPAC, as trendy IPO path continues

March 29, 2021
By Meg Bryant
Somalogic Inc. has agreed to go public via a merger with blank-check company CM Life Sciences II. Upon closing, CMLS II – a special purpose acquisition company (SPAC) sponsored by affiliates of Casdin Capital LLC and Corvex Management LP – will be renamed Somalogic and its common stock listed on the Nasdaq Global Market under the ticker symbol SLGC.
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Antibodies block virus from cell

EU sets guidelines for COVID rapid antibody tests

March 29, 2021
By Nuala Moran
LONDON – Getting a handle on the specificity and sensitivity of rapid COVID-19 antibody tests, how they compare to each other and how they should be applied in population screening to understand who has had the virus and how it has spread, has been a source of difficulty and dispute between manufacturers, clinicians and public health experts.
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SARS-CoV-2 illustration turns from blue to red

FDA grants Twist Bioscience and Biotia EUA for capture-based NGS SARS-CoV-2 assay

March 26, 2021
By Annette Boyle
South San Francsico-based Twist Bioscience Corp. and Biotia Inc., of New York, received the first FDA emergency use authorization (EUA) for a capture-based next-generation sequencing (NGS) assay for the coronavirus that causes COVID-19. The technique reduces the likelihood of misdiagnosing or failing to identify mutations compared to standard sequencing.
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Canada pinned on globe

The school bell has already rung on recommendations for testing Canadian students for COVID-19, say critics

March 26, 2021
By David Godkin
TORONTO – A distinguished Canadian health care policy expert said a report from Canada’s COVID-19 Testing and Screening Expert Advisory Panel recommending testing and screening for school-age children and teachers comes “late in the game” now that the focus has shifted to vaccinating the Canadian population.
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Fluxergy products

Fluxergy corrals CE mark for 1-hour COVID-19 test

March 25, 2021
By Meg Bryant
Fluxergy Inc. said Thursday that it has won CE-IVD marking for its one-hour COVID-19 real-time polymerase chain reaction (RT-PCR) test. The automated, sample-to-action Fluxergy diagnostic testing system can run multiple assay types – such as molecular, immunochemistry, chemistry and cytometry – simultaneously on the same cartridge. The SARS-CoV2 RT-PCR test is the first CE-marked product for the Fluxergy diagnostic platform.
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Cancer cell and DNA

Genetron’s blood-based HCC test shows promising results vs. the standard of care

March 25, 2021
By Elise Mak
Genetron Holdings Ltd. said its blood-based, early screening test for hepatocellular carcinoma (HCC) demonstrated 88% sensitivity and 93% specificity in 1,615 subjects in China vs. 71% sensitivity and 95% specificity with the use of ultrasound plus alpha-fetoprotein (AFP). The primary outcome, unveiled on March 25, came from a multicenter prospective trial that Beijing-based Genetron initiated together with The National Cancer Center China in 2019.
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BioWorld MedTech’s Diagnostics Extra for March 25, 2021

March 25, 2021
By Meg Bryant
Keeping you up to date on recent developments in diagnostics, including: Review highlights differences in accuracy of COVID-19 rapid tests; Likelihood of disease from hidden genetic defects; Confocal PET enables color differentiation of PET tracers in preclinical imaging.
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Guerbet reports positive phase III data for gadopiclenol

March 25, 2021
Lungs wireframe illustration

FDA greenlights Optellum's AI-powered software for early lung cancer diagnosis

March 24, 2021
By Annette Boyle
The rapidly expanding field artificial intelligence (AI)-aided image analysis received a boost with the FDA 510(k) clearance for Optellum Ltd.’s Virtual Nodule Clinic, which helps clinicians evaluate small, potentially malignant lung lesions or nodules. The action makes Optellum’s system the first cleared radiomic application for early lung cancer, an area of active research for the last five years.
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