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BioWorld - Sunday, December 28, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Hands holding arrow-shaped puzzle pieces

Roche acquiring Genmark in $1.8B merger

March 15, 2021
By Annette Boyle
Roche Holding AG will acquire Genmark Diagnostics Inc. for $24.05 per share in cash for a total of $1.8 billion on a fully diluted basis. The transaction will give Basel, Switzerland-based Roche access to Genmark’s molecular diagnostics portfolio. The deal is expected to close in the second quarter of 2021. The price represents a 43% premium on the Carlsbad, Calif.-headquartered diagnostics company’s share price as of Feb. 10, prior to media speculation about a potential acquisition.
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DNA, dollars illustration

Variantyx scoops up $20M for whole genome sequencing-based testing methodology

March 15, 2021
By Meg Bryant
Variantyx Inc. raised $20 million in a series C financing led by GHS Fund (Quark Venture LP and GF Securities). The new funds are earmarked for the development of comprehensive tumor diagnostic solutions and sales expansion. Also taking part in the round were new investor IBM Ventures and existing investors Pitango Venture Capital, New Era Capital Partners and 20/20 Healthcare Partners. With this latest infusion, Variantyx has raised a total of $38 million.
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Datar wins CE mark for Trublood cancer detection system

March 15, 2021
By Nuala Moran
LONDON – Following circulating tumor cells and cell-free tumor DNA, a new type of liquid biopsy is poised for commercial rollout after Datar Cancer Genetics Ltd. secured CE marking for Trublood, a method for isolating tumor cell clusters. In fact, the clusters do not consist solely of tumor cells, but can also include endothelial cells, erythrocytes, stromal cells, leukocytes, platelets, and cancer-associated fibroblasts. They are held together by cell-to cell-adhesion proteins.
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Doctor oversees patient with Corvista system

Heartened by rapid cardiovascular test, investors pump another $65M into Corvista

March 12, 2021
By David Godkin
Corvista Health Inc., a subsidiary of Toronto-based Analytics for Life Inc., reported closing on $65 million in series C equity financing, bringing total cash raised for a new cardiac diagnostics device to nearly $100 million. The Corvista system is described as noninvasive, point-of-care diagnostic system for coronary artery and other cardiovascular diseases.
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Software screenshots

I-O Urology introduces remote digital diagnostic platform for urologic care

March 11, 2021
By Annette Boyle
I-O Urology Corp. launched its Carepath platform to provide remote patient monitoring for urologic conditions. The platform uses a compact portable system to capture real-time urine voiding data and a mobile app to facilitate accurate reporting and timely communication between patients and their health care providers.
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Steadying hand while reaching for glass

Researchers developing test for earlier diagnosis of Parkinson’s

March 11, 2021
By Nuala Moran
LONDON – New research shows it is possible to diagnose Parkinson’s disease by mass spectrometry analysis of sebum samples taken with a simple skin swab, and that the same technique has potential to be used for diagnosing COVID-19. In a paper published in Nature Communications on March 11, 2021, scientists and clinicians in the U.K. and the Netherlands describe using high resolution mass spectrometry to profile the chemical signature of lipids and other biomarkers in sebum from Parkinson’s patients and show how these exhibit subtle but fundamental changes as the disease progresses.
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BioWorld MedTech’s Diagnostics Extra for March 11, 2021

March 11, 2021
By Meg Bryant and Anette Breindl
Keeping you up to date on recent developments in diagnostics, including: Quality of smartphone-transmitted skin images; A noninvasive test for kidney transplant rejection; Fungal culprit in Crohn’s disease.
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Cancer cell and DNA

Inivata wins breakthrough designation for Radar cancer detection assay

March 10, 2021
By Nuala Moran
LONDON – Liquid biopsy specialist Inivata Ltd. has been granted a U.S. FDA breakthrough device designation for its Radar assay for detecting residual disease or relapse, following treatment for cancer. The personalized assay, which tracks a set of up to 48 genetic variants isolated from excised tumor tissue, is built on Inivata’s approved Invision platform for detecting circulating tumor DNA (ctDNA) in blood samples.
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U.S. flag and money
ACLA annual meeting

Rep. Guthrie aware PAMA rate reset a problem, but non-committal about reform

March 10, 2021
By Mark McCarty
The first day of the annual meeting of the American Clinical Laboratory Association (ACLA) included a brief address by two members of Congress, including Rep. Brett Guthrie (R-Ky.), who chairs the health subcommittee of the House Energy and Commerce Committee. Guthrie acknowledged that the reset of the Medicare clinical lab fee schedule was not going as intended, but declined to identify any possible fixes pending a report by the Medicare Payment Advisory Commission.
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Smartwatch on wrist next to smartphone with Empatica Care app on screen

Empatica wins CE mark for wearable-based early symptoms detection of COVID-19

March 10, 2021
By Meg Bryant
MIT Media Labs spinoff Empatica Inc. secured the CE mark for its Aura system, a wearable solution for the monitoring and early alert of respiratory infections, including COVID-19. For use with people 14 and older, Aura is commercially available in Europe and the U.K., and for pilot purposes in the U.S. – pending FDA authorization. Aura’s algorithm analyzes vital signs from Empatica smartwatches, comparing data against the wearer’s historical baselines. In validation studies, Aura was able to detect patients with possible H1N1 influenza, rhinovirus or SARS-CoV-2 infection with 0.94 sensitivity. Detection occurred on average two days after infection.
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