Search Results for 'sars-cov-2'
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Diagnostics
Hologic's Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Gains FDA Nod
The assay is a molecular test that spots and differentiates four of the most common respiratory viruses.Sam Brusco, Associate Editor 05.19.23
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Diagnostics
Mawi DNA’s iSWAB-RC-EL for SARS-CoV-2 Granted 510(k) Clearance
Mawi DNA developed the iSWAB-RC-EL bio sampling device for surveillance testing of COVID-19 and its variants in any clinical setting.Charles Sternberg, Associate Editor 04.26.23
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Diagnostics
Mologic COVI-Go SARS-CoV-2 Ag Self-Test Receives FDA EUA for Home Use
The COVI-Go COVID-19 Self-Test is a differentiated, rapid antigen test that is easy to use.Charles Sternberg, Associate Editor 02.23.23
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Diagnostics
Siemens Healthineers Confirms That Its SARS-CoV-2 Tests Detect the Omicron Variant
As countries struggle to combat emerging variants, fast and accurate testing is an important tool in containing spread.Siemens Healthineers 12.15.21
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Diagnostics
PerkinElmer Launches NEXTFLEX Variant-Seq SARS-CoV-2 Kit v2
NGS assay will help labs increase sequencing throughput and reliably identify variants.Sam Brusco, Associate Editor 12.08.21
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Diagnostics
Carbon Nanotube Sensor Can Spot SARS-CoV-2 Proteins
Could be developed as a rapid diagnostic for Covid-19 or other emerging pathogens.Anne Trafton , MIT News Office 10.27.21
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Diagnostics
CerTest Biotec & BD Add Saliva to the Visasure SARS-CoV-2 Detection Kit
Allows BD MAX System users more flexibility with three alternatives for specimen collection.Charles Sternberg, Assistant Editor 04.27.21
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Diagnostics
BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test
Also shows ability to detect U.K., South African variants of COVID-19.Sam Brusco, Associate Editor 02.12.21
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Diagnostics
PerkinElmer's SARS-CoV-2 RT-PCR Assay Earns EUA for Asymptomatic Testing
Gold-standard testing of individuals without COVID-19 symptoms key to controlling the spread.Business Wire 01.14.21
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Diagnostics
SARS-CoV-2 Mutation Prompts FDA Alert
Impact remains low, but false negative results can occur with any molecular test.U.S. Food and Drug Administration 01.11.21
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Diagnostics
Roche's Elecsys Anti-SARS-CoV-2 S Antibody Test Earns EUA
Detects antibodies against the SARS-CoV-2 spike protein.GlobeNewswire 12.02.20
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Diagnostics
QIAGEN Launches Portable Digital SARS-CoV-2 Antigen Test
Can accurately analyze over 30 samples per hour.Business Wire 11.12.20
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Diagnostics
GenScript's SARS-CoV-2 Neutralizing Antibody Detection Kit Wins EUA
Only EUA authorized virus-free testing assay that detects neutralizing antibodies within an hour.PR Newswire 11.09.20
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Diagnostics
Agena Bioscience's High-Throughput, Low-Cost SARS-CoV-2 Panel Gains EUA
Thousands of samples can be processed each day for less than $10 per sample running the assay on a single MassARRAY instrument.PR Newswire 10.28.20
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Diagnostics
Beckman Coulter's SARS-CoV-2 IgM Antibody Test Receives EUA
The test demonstrates 99.9 percent specificity and 98.3 percent sensitivity.PR Newswire 10.09.20
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Diagnostics
BD's SARS-CoV-2 Antigen Test OKed in Europe
Portable, rapid PoC antigen test to detect SARS-CoV-2 in 15 minutes to be available in Europe by end of October.PR Newswire 09.30.20
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Diagnostics
Vela Diagnostics' SARS-CoV-2 RT-PCR Test v2.0 Earns EUA
Automated test enables high throughput testing of up to 46 samples in a single run.PR Newswire 09.24.20
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Diagnostics
Roche Earns EUA for SARS-CoV-2 & Influenza A/B Combo Test
Detects and differentiates SARS-CoV-2, influenza A virus, and/or influenza B virus with a single sample.Roche 09.04.20
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Diagnostics
Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR Assay Gains EUA
Easy-to-administer saliva test for COVID-19 available for immediate shipment.GlobeNewswire 08.26.20
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Diagnostics
Avacta Announces SARS-CoV-2 Rapid Antigen Test Clinical Collaboration
Avacta and Liverpool School of Tropical Medicine collaborate to clinically validate saliva-based rapid coronavirus test being developed with Cytiva.Avacta Group plc 08.10.20
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Diagnostics
BD Launches Portable Antigen Test to Detect SARS-CoV-2
Expands access to COVID-19 testing.BD 07.06.20
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Diagnostics
Beckman Coulter's SARS-CoV-2 IgG Antibody Test Receives FDA EUA
The company is able to deliver more than 30 million tests a month.PRNewswire 06.29.20
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Diagnostics
Babson Diagnostics' SARS-CoV-2 IgG Antibody Test Receives EUA
Enables qualitative detection of IgG antibodies to SARS-CoV-2 with 100 percent sensitivity and specificity.Business Wire 06.25.20
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Diagnostics
Applied BioCode SARS-CoV-2 Assay Granted EUA
Assay for SARS-CoV-2 nucleic acids can deliver up to 564 sample results in a day.Business Wire 06.17.20
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Diagnostics
EUA Granted for High-Throughput, Low-Cost SARS-CoV-2 Panel
The single-reaction panel targets five regions of the viral genome.PR Newswire 06.16.20
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Diagnostics
ChromaCode's SARS-CoV-2 Real-Time PCR Assay Earns EUA
Assay increases test throughput and reduces complexity of interpretation.PR Newswire 06.10.20
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Diagnostics
Cepheid Developing Combination Test for SARS-CoV-2, Flu A/B, and RSV
Four viral infections have similar patient presentations; accurate detection and differentiation critical next flu season.PR Newswire 06.09.20
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How Are MPO’s Top 30 Addressing COVID-19?
J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.Online Exclusives Sam Brusco, Associate Editor 06.09.20
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Diagnostics
Siemens Healthineers' SARS-CoV-2 Total Antibody Test Earns EUA
Has demonstrated 100 percent sensitivity and 99.8 percent specificity in identifying SARS-CoV-2 antibodies.Business Wire 06.01.20
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Diagnostics
Quidel's Lyra Direct SARS-CoV-2 Assay Receives EUA, CE Mark
Lyra Direct removes RNA extraction processing step, removes supply bottleneck.Business Wire 05.19.20
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Diagnostics
Gold Standard Diagnostics Launches Multiplex Real-Time PCR Assay for SARS-CoV-2
PCR is the method of choice to detect acute coronavirus infections.Business Wire 05.18.20
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Diagnostics
Bio-Rad's Droplet Digital PCR SARS-CoV-2 Test Kit Granted EUA
Test's high sensitivity makes it well suited to screening upper respiratory samples in patients with a low viral load.Business Wire 05.05.20
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Hologic to Release Second High-Throughput SARS-CoV-2 Molecular Assay
At least one million tests a week to run on more than 1,000 Panther instruments.Business Wire 04.30.20
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Diagnostics
BIOTECON Launches SARS-CoV-2 Screening and Identification Kits
The assays are based on the WHO reference methods.PR Newswire 04.28.20
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Diagnostics
BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test
Adds automated extraction methods and additional PCR systems.PR Newswire 04.27.20
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Ortho's Second COVID-19 Antibody Test With 100 Percent Specificity Debuts
Tests will aid in responsible back-to-work assessment, according to manufacturer.Ortho Clinical Diagnostics 04.27.20
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Diagnostics
Vela Diagnostics' COVID-19 Detection Test Earns CE Mark
Vela Diagnostics has also developed an automated version of the test slated for CE-IVD registration this month.PR Newswire 04.24.20
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Diagnostics
WytCote Introduces Three-Minute COVID-19 Antibody Test
The company has applied to the FDA for Emergency Use Authorization.PR Newswire 04.24.20
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FDA OKs Baxter's Oxiris Blood Purification Filter for COVID-19 Treatment
Only filter set available in the U.S. to reduce pro-inflammatory cytokine levels in the blood.Baxter 04.24.20
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CENTOGENE Releases New Swab Product to Facilitate COVID-19 Diagnosis
The kit has a sterile package containing a swab and collection tube.Globe Newswire 04.24.20
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Diagnostics
Siemens Healthineers to Expand SARS-CoV-2 Testing
With a demonstrated sensitivity and specificity of more than 99 percent, the test is expected to exceed the stringent FDA quality guidelines.Siemens Healthineers 04.23.20
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Diagnostics
Enzo Biochem Launches COVID-19 Diagnostic Test
Proprietary molecular diagnostic kits offer improved scale, throughput, and sensitivity.Business Wire 04.23.20
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Diagnostics
FDA OKs Seegene's Allplex 2019-nCoV Assay
Seegene's technology has played a pivotal role in South Korea's rapid response to the COVID 19 outbreak.PR Newswire 04.22.20
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Diagnostics
GenoSensor's High-Throughput COVID-19 RT-PCR Diagnostic Granted FDA EUA
Provides test results in less than 90 minutes.Business Wire 04.21.20
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Diagnostics
FDA Update: COVID-19 Antibody Test Validation and Education
Results from these tests can help identify who has been infected and developed antibodies.U.S. Food and Drug Administration 04.20.20
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Terumo's Mirasol Shows Efficacy Against Virus Causing COVID-19 in Plasma, Platelets
The pathogen reduction system is designed to add an extra layer of safety to the blood supply.Terumo BCT 04.20.20
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Diagnostics
ELITechGroup MDx, OSANG Healthcare Receive Emergency Use Authorization for COVID-19 Test Kits
Test delivers qualitative results within hours.PR Newswire 04.20.20
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Diagnostics
Gold Standard Diagnostics Releases Three COVID-19 Antibody Tests
The IgA, IgG, and IgM assays are formatted for optimal functionality in diagnostic laboratories.Business Wire 04.17.20
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Diagnostics
Sense Biodetection Accelerates Instrument-Free COVID-19 Diagnostic Test
Scale-up with Phillips-Medisize is underway to ensure timely delivery and distribution.Sense Biodetection Limited 04.17.20
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Diagnostics
CRISPR-Based Test Kit Can Diagnose COVID-19 in Under an Hour
DETECTR test can be performed in virtually any lab, using off-the-shelf reagents and common equipment.Jason Alvarez, University of California - San Francisco 04.16.20
