NeuMoDx coronavirus test gets emergency authorization

LabPulse.com staff writers
Mar 31, 2020
2019 05 02 23 38 2538 Check Mark 400

NeuMoDx Molecular's assay for SARS-CoV-2 has received an emergency use authorization (EUA) from the U.S. Food and Drug Administration.

The reverse transcription polymerase chain reaction (RT-PCR) test was designed for use on the company's high-throughput NeuMoDx 288 and 96 molecular systems in CLIA-certified hospitals and labs that perform high-complexity testing. Results are available in as little as 80 minutes, according to the company.

NeuMoDx also noted that reagents and consumables associated with the SARS-CoV-2 test are ready to use and do not require refrigeration.

Latest in PCR
Coronavirus Covid Blue Social
Researchers develop technique for onsite detection of SARS-CoV-2
October 10, 2023
Test Tubes Social
NIH researchers develop PCR assay for easier diagnosis of river blindness
October 9, 2023
Bacteria Blood Sepsis Social
Nonprofit health system adopts Immunexpress test for detecting sepsis
August 23, 2023
Lung Cancer Hotspot Social
ChromaCode starts early-access launch of lung cancer variant test
August 15, 2023
Related Stories
2020 02 25 17 48 0053 Thumbs Up New 400
PCR
Ipsum gets FDA nod for COVID-19 test
2020 03 20 23 29 9036 Virus Coronavirus Microscope 400
Health Topics
BioIQ readies COVID-19 saliva test
2020 01 21 22 13 2411 Virus Coronavirus 400
Immunoassays
BodySphere's 2-minute antibody test for COVID-19 gets green light in U.S.
2020 03 31 18 05 5944 2020 03 31 Qiagen Qi Astat Covid 19 20200331181326
COVID-19
Qiagen gets FDA nod for syndromic SARS-CoV-2 test
More in PCR
Researchers develop technique for onsite detection of SARS-CoV-2
Researchers have developed a portable laboratory device for rapid onsite detection of SARS-CoV-2 RNA which holds promise for scenarios in which there is no or limited access to testing laboratories.
October 10, 2023
Coronavirus Covid Blue Social
NIH researchers develop PCR assay for easier diagnosis of river blindness
U.S. National Institutes of Health (NIH) researchers have developed a new PCR assay to detect Onchocerca volvulus, the parasite that causes onchocerciasis, or river blindness, and are working to adapt it for easier field diagnosis of the disease.
October 9, 2023
Test Tubes Social
Nonprofit health system adopts Immunexpress test for detecting sepsis
FirstHealth of the Carolinas, a nonprofit health system licensed for four hospitals in North Carolina, will use Immunexpress’ SeptiCyte Rapid test to help differentiate sepsis-positive cases from patients with infection-negative systemic inflammation.
August 23, 2023
Bacteria Blood Sepsis Social
ChromaCode starts early-access launch of lung cancer variant test
The test is designed to address diagnostic problems that prevent patients from undergoing timely cancer biomarker testing and receiving targeted therapies.
August 15, 2023
Lung Cancer Hotspot Social
Studies show Pathnostics UTI test required fewer resources, reduced costs compared to standard testing
In the study, the average one-year costs related to UTIs were $501.85 lower for patients receiving treatment based on the Guidance test than for those receiving treatment based on the traditional culture test.
June 20, 2023
Bladder Urinary 3 D Social
Roche receives WHO prequalification for HPV screening tool
Prequalification helps expand access to the screening tool in countries that rely on the WHO's list of prequalified suppliers in making purchasing and implementation decisions.
June 13, 2023
Lab Woman Dna Social
Eurobio Scientific obtains IVDR CE markings for PCR tests
The CE markings enable the firm to market three of its PCR tests as class C in vitro diagnostic medical devices for the detection of infectious diseases.
May 24, 2023
Business Regulation Graphic Social Resized
A. Menarini launches full automated MDx platform at WorldLab-EuroMedLab
The system, Prime MDx, is an all-in-one, sample-to-result platform designed to allows users to process a variety of sample types through real-time polymerase chain reaction (PCR), the Florence, Italy-based firm said.
May 23, 2023
Artificial Intelligence Ai Social
BioMĂ©rieux receives FDA CLIA waiver for multiplex PCR respiratory panel
In about 15 minutes, the panel detects five of the most common viral causes of upper respiratory tract infections: SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus (RSV), and rhinovirus.
May 11, 2023
Patient Doctor Women Social
Bio-Rad Laboratories Q1 net sales drop 3%; firm lowers full-year guidance
Bio-Rad shares were down on Friday, a day after the firm updated its financial outlook for full-year 2023; it anticipates non-GAAP currency-neutral revenue growth of approximately 4.5% compared to its previous estimate of 6% to 7%.
May 5, 2023
Business Financial Results Social
Qiagen launching syndromic molecular diagnostic system with respiratory panel in Japan
Qiagen said Monday that its QIAstat-Dx syndromic testing system is expected to be available soon in Japan with a SARS-CoV-2 Respiratory Panel that can detect more than 20 pathogens from a patient sample.
April 24, 2023
Women Laboratory Social
Curative spins off Sensible Diagnostics to commercialize point-of-care PCR platform
The spin-off is utilizing the experience Curative has gained with its diagnostics business during the pandemic, having run more than two million molecular point-of-care COVID-19 tests.
April 24, 2023
Blood Test Samples Lab Social
Page 1 of 22
Next Page