Consumer: Page 5

Konica Minolta, Amazon partner on data platform
By LabPulse.com staff writers
Amazon will support the build-out of Lattice, a platform that combines genomics, pathology, and radiology data along with other critical information to discover clinically relevant biomarkers and create diagnostic tests.
March 9, 2021
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FDA releases new guidance for developers of COVID-19 products
By LabPulse.com staff writers
Among other documents, the agency has issued a policy for evaluating impact of viral mutations, which explains the effect of variants on test performance, due to a number of factors including the type of variant and test design. The guidance document provides instruction for test developers on how to design products with variants in mind and to monitor performance over time as new mutations of the virus emerge.
February 22, 2021
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Visby gets $12M to make flu/COVID-19 self-tests
By LabPulse.com staff writers
The test detects the flu and/or COVID-19 using one handheld rapid PCR test for point-of-care use. Eventually, it will be available in consumers' homes as an over-the-counter test.
February 2, 2021
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Sherlock gets $5M to advance COVID-19 self-test platform
By LabPulse.com staff writers
The Bill & Melinda Gates Foundation provided the grant for the instrument-free, synthetic biology-based molecular diagnostic platform that can be used at home and at room temperature. The platform can be adapted to work on a simple paper strip test or to provide an electrochemical readout that can be read with a mobile phone.
December 15, 2020
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FDA issues EUA for Ellume's at-home COVID-19 test
By LabPulse.com staff writers
In announcing the EUA, the FDA said the authorization was the first for an over-the-counter, fully at-home diagnostic test for COVID-19. Ellume's COVID-19 Home Test is a rapid lateral-flow antigen test, a type of diagnostic test that runs a liquid sample along a surface with reactive molecules, detecting protein fragments of the SARS-CoV-2 virus from nasal swabs.
December 14, 2020
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Report: LDT market to exceed $17B
By Bruce Carlson
The findings come from LabPulse.com sister company and IVD research firm Kalorama Information in a new report, "The Market for Clinical LDT Services and LDT Supplies." Kalorama noted that the LDT market is driven by relaxed regulatory activity and the need for improved cancer tests.
October 19, 2020
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Top companies earn 80% of revenue in IVD market
By Bruce Carlson
In recent years, this group of top-tier companies has increased its ownership position of the market. At the same time, Kalorama found that there are still opportunities for new companies. Roche and Abbott are world market leaders, according to the firm's report titled "Worldwide Market for In Vitro Diagnostic Tests," published in August.
September 10, 2020
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Market for IVD to reach $83.3B
By Bruce Carlson
Kalorama's "Worldwide Market for In Vitro Diagnostics" is the 13th edition of the report and is due to be published August 26. The report reveals that the 2020 market for IVD was substantial and growing, even before the COVID-19 pandemic hit.The IVD market in 2020 compared to prior years. Image courtesy of Kalorama.The IVD market in 2020 compared to prior years. Image courtesy of Kalorama.
August 17, 2020
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Digital pathology woos new users, thrives in pandemic market
By Bruce Carlson
Kalorama Information's recent report Digital Pathology Markets, 2020-2025 found a vibrant market that is being propelled by the need for faster cancer detection and the enhancements that IT systems -- including artificial intelligence (AI) solutions -- provide.
August 2, 2020
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COVID-19 powers $5B in molecular diagnostics market growth
By Bruce Carlson
Furthermore, the market could remain up for some time, according to the July 9 report, which addressed molecular diagnostics in the COVID-19 era. Kalorama developed sales estimates and forecasts using country- and state-reported test volumes, pricing data, and revenues of IVD manufacturers. The worldwide market includes reagents and instruments and directly related sales. Estimates do not include laboratory revenues, only revenue to IVD manufacturers. Also, no antibody sales were included in the total.
July 12, 2020
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World market outlook: COVID-19 testing evolves rapidly, lessons sink in
By Justin Saeks
Worldwide, COVID-19 testing volume was on target to grow 25%-30% from May to June. New products and services are continually being introduced, and regulatory approvals have been growing and expanding to include more types of tests, samples, and sample collection methods.
June 28, 2020
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Epredia to distribute Lunaphore's LabSat Research platform
By LabPulse.com staff writers
The LabSat Research platform is an automated tissue staining system for immunohistochemistry and immunofluorescence. It uses microfluidic technology to provide rapid delivery of reagents to tissue samples.
June 15, 2020
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