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The firm said the BARDA funding will support scale-up of a molecular test to facilitate management of the coronavirus pandemic cycle.
The NeuMoDx SARS-CoV-2 Test Strip can run on the firm's fully-automated mid- or high-throughput instruments.
The panel can detect and differentiate SARS-CoV-2 and 20 other pathogens known to cause serious respiratory disease from nasopharyngeal swabs in symptomatic patients.
The analyzer supports COVID-19 response efforts, where blood-gas testing plays a critical role in monitoring patients' respiratory distress, the firm said.
The Aries SARS-CoV-2 assay provides results in approximately two hours and can be run on Luminex's sample-to-answer Aries Systems.
Thermo Fisher plans to use the proceeds to pay in part for the acquisition of Qiagen, expected to close in the first half of 2021, and for general corporate purposes.
The lawsuit also alleges Anthem failed to delete inaccurate diagnosis codes, leading to inflated risk-adjustment payments from Medicare.
The company said the kit can provide results within 90 minutes, with sensitivity and specificity of detection reaching the level of traditional PCR methods.
Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.
In a letter, the Trump administration has asked hospitals to report their SARS-CoV-2 testing data every day to HHS.
Droplet digital PCR tests for SARS-CoV-2 can potentially detect the very low viral loads seen in asymptomatic and convalescent cases.
The ID Now COVID-19 test is the second assay from the company to receive EUA from the FDA, following the same designation issued to the Abbott RealTime SARS CoV-2.
The NxTag CoV Extended Panel is a multiplex PCR test that uses the company's bead-based NxTag technology to detect coronavirus in nasopharyngeal swab specimens.
The Swedish firms plans to launch clinical performance studies in support of getting CE marking for its QuickMIC system.
FIND will use the funding to support the development of rapid tests, especially in low- and middle-income countries.
In addition, Biolidics entered a distribution agreement with Clearbridge Medical Group to distribute tests in multiple Asian countries and Australia.
Sysmex anticipates delivering the kit to Japanese medical institutions this month for diagnosis of the SARS-CoV-2 infection.
The BGI Real-Time Fluorescent RT-PCR Kit for detecting SARS-2019-nCoV runs in approximately three hours and can be manufactured in large volumes, the firm has said.
The AvellinoCoV2 real-time PCR test is designed for the detection of nucleic acid from SARS-CoV-2 from nasopharyngeal and oropharyngeal swab specimens.
If the bill passes in its current form, PAMA reporting would be delayed until January 2022 and rate cuts scheduled for 2021 would be put off to 2022.
The company reported total revenues of $1.31 million, up from $922,000 in Q4 2018, and 3,854 OVA1 sales, up 93 percent from 1,996 a year ago.
University of Oxford researchers said they are weeks away from completing clinical validation of a coronavirus molecular test based on RT-LAMP technology.
News items for the in vitro diagnostics industry for the week of March 23, 2020.
The anti-SARS-CoV-2 antibodies for classes IgA and IgG are two of the first antibody detection tests to receive CE making and be made available for SARS-CoV-2 testing.
Such tests indicate whether a person had an immune response to the virus, which could aid infection tracking and identifying individuals with immunity.