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BioWorld - Sunday, June 21, 2026
Home » Topics » Medical technology » Diagnostics

Diagnostics
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Chromium X product image

10x Genomics releases new high-throughput single-cell analysis platform

July 14, 2021
By Annette Boyle
10x Genomics Inc. launched its latest platform for single-cell analysis, the Chromium X Series, to cost-effectively "enable massively large-scale experiments," according to the company. The system cuts the cost of single-cell analysis 83%, from 12 cents to 2 cents per cell, a significant step toward reducing the costs low enough to make genomic sequencing widely available.
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Vocal soundwave illustration

Qualcomm to integrate Sonde One vocal health tracker on mobile device chips

July 13, 2021
By Annette Boyle
Sonde Health struck a deal with Qualcomm Technologies Inc. to embed its vocal health biomarker product, Sonde One, in the Snapdragon 888 and 778G 5G mobile platforms. The deal would make vocal biomarker monitoring native to the devices that use the company’s chips in mobile and IoT devices.
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European Commission headquarters

EC issues guidance on EU IVDR codes to offset NB burden

July 13, 2021
By Ana Mulero
The European Commission (EC) posted a new explanatory note on Tuesday that provides guidance on the codes set under the European In Vitro Diagnostic Regulation (IVDR) to define the notified body (NB) scope of designation and qualification required for assessing a device. The clarifications explain how to use the different levels of codes to guide the proper allocation of resources, citing the anticipated challenges with limited experience and competency of NBs.
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Hepion’s positive phase IIa NASH data disappoint the Street

July 13, 2021
By Lee Landenberger
All the primary endpoints were met in Hepion Pharmaceuticals Inc.’s phase IIa trial of CRV-431 for treating nonalcoholic steatohepatitis (NASH). The market, however, wasn’t celebrating as the Edison, N.J.-based company’s stock (NASDAQ:HEPA) sagged 15.27% on July 13 to close at $1.72 per share.
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Colorectal cancer illustration

Geneoscopy launches pivotal trial of RNA-based at-home colorectal cancer screening test

July 12, 2021
By Meg Bryant
Diagnostics startup Geneoscopy Inc. has enrolled the first patients its pivotal CRC-PREVENT clinical trial. The interventional study will assess the safety and efficacy of the company’s noninvasive, at-home, multifactor RNA screening test for the prevention of colorectal cancer.
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FDA clears eIND for 68Ga-RMX-VH in glioblastoma multiforme

July 9, 2021
Man piecing together a puzzle

Cognetivity’s AI-based early-stage Alzheimer’s detection test may ‘save a fortune’

July 8, 2021
By Ana Mulero
A five-minute artificial intelligence (AI)-based system from Cognetivity Neurosciences Ltd. that can detect common symptoms of Alzheimer’s disease years before they become visible using a tablet or smartphone is poised to change how this devastating disease is diagnosed.
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Brain with handshake and cityscape

Hyperfine, Liminal Sciences join up in latest SPAC merger

July 8, 2021
By Meg Bryant
Hyerfine Inc. and Liminal Sciences Inc. have joined a growing field of med-tech startups that are combining with blank check companies as an alternative path for venture-backed companies to an initial public offering (IPO). On Thursday, the companies announced a three-way combination with Healthcor Catalio Acquisition Corp., a special purpose acquisition company (SPAC), in a deal valued at approximately $580 million.
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Innova's COVID-19 antigen test

Innova’s lateral flow test improved COVID-19 detection, reduced potential deaths

July 7, 2021
By Nuala Moran
LONDON – Final results of the community pilot in Liverpool, U.K., that used the controversial Innova Medical Group Inc. lateral flow device to test all comers for COVID-19, show new cases fell by 21% compared to other areas of the U.K., because infections were detected early and people quarantined sooner.
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New beta-amyloid PET imaging agent [18F]Flotaza shows promise in Alzheimer's disease brain

July 7, 2021
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