Bruce Carlson[email protected]Emergency Use AuthorizationIVD firms ready high-throughput antigen testsCurrently marketed tests are primarily rapid tests performed at the point of care and can be confirmed by polymerase chain reaction (PCR) testing. Several firms now have emergency use authorization (EUA) for rapid antigen tests for COVID-19, and soon a new type of test should be brought to bear: antigen tests on automated systems that can run hundreds of tests per hour. Some of these tests are already marketable in countries that accept the CE Mark.November 22, 2020Moderate Complexity TestReport: LDT market to exceed $17BThe 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, 2020Point-of-Care TestingUrgent care centers earn over $400M from COVID-19 testingUCCs are defined as walk-in healthcare venues that are not within a retail store but can be in a strip mall or freestanding building. They offer a range of services, expanded hours, and limited wait times. They usually have imaging equipment and multiple providers.September 30, 2020ConsumerTop companies earn 80% of revenue in IVD marketIn 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, 2020InfectiousTop 5 facts about the IVD marketAmong other information and individual test segment reporting in the more than 1,800 page report were the following five facts:August 31, 2020ConsumerMarket for IVD to reach $83.3BKalorama'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, 2020Pathology, histologyDigital pathology woos new users, thrives in pandemic marketKalorama 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, 2020510(k)Could COVID-19 end standoff on tests developed in laboratories?Labs developing their own tests for a variety of conditions make up a significant part of testing in the U.S. and other countries, according to Kalorama Information, a sister company of LabPulse.com. While there is a $70Â billion market for IVD products, commercial tests are not always sufficient for demand. Laboratory-developed tests were controversial before the COVID-19 pandemic, and there were attempts at imposing more scrutiny on them in the U.S., where an enforcement loophole has kept labs relatively unregulated by the U.S. Food and Drug Administration (FDA).July 16, 2020Molecular DiagnosticsCOVID-19 powers $5B in molecular diagnostics market growthFurthermore, 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, 2020Companion DiagnosticsCompanion diagnostics survive COVID-19 with small nickKalorama, which is a sister company of LabPulse.com, found continued revenue growth and only a small impact on the market, due to the critical importance of cancer therapies these tests are paired with, in its new report "Companion Diagnostics in the COVID-19 Era."July 5, 2020Previous PagePage 4 of 7Next PageTop StoriesDiagnostic TechnologiesFDA said no to proficiency testing for LDT qualityInferior tests can pass through proficiency testing, among ways PT falls short for test safety and effectiveness for intended purposes.Policy and RegulationFDA releases LDT final ruleResearch AllianceGSK, Genomics PLC collaborate on polygenic risk score use for clinical trialsCOVID-19Study: Age-related differences in nasal cells offer COVID-19 protectionSponsor ContentVisit our Molecular Diagnostics Community