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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.
The kit, which is CE marked, is designed to detect the virus' ORF1ab, N, and E genes, and can process 96 samples within two hours.
The financing will go toward development of miDiagnostics' nanofluidic process on a chip as it prepares it for industrial-scale manufacturing.
The agency provided an overview of its policies regarding COVID-19 test regulations, as well as additional color and clarification, in a webinar.
The point-of-care test is designed for the qualitative presumptive detection of specific IgM and IgG antibodies to SARS-CoV-2 in a fingerstick blood sample.
The test, which uses an Applied Bioystems TaqPath assay and real-time PCR technology, detects nucleic acid from SARS-CoV-2, the virus that causes COVID-19.
Biocartis will lead commercialization in Europe as the exclusive distributor of the SeptiCyte Rapid test, while Immunexpress will lead commercialization of the test in the US.
The funds will go toward general corporate purposes, possibly including repayment of a portion of its outstanding commercial paper borrowings.
The company's revenue growth was driven in part by a US copromotion alliance for Janssen Biotech's rheumatoid arthritis drug Simponi.
Now, the assay can also be used with the Applied Biosystems 7500 Standard from Thermo Fisher Scientific, Roche's LightCycler 480, and Qiagen's Rotor-Gene Q.
The company has issued a call for the 2,500 independent MDx labs across the US to join together in an effort to double SARS-CoV-2 testing capacity.
For FY 2019, the firm's revenues dropped 11 percent to $19.2 million from $21.5 million in 2018, matching analysts' expectations.