50 Science Park Road, Level 2, The Kendall
Science Park II
25 articles with Vela Diagnostics
The ViroKey™ SARS-CoV-2 RT-PCR Test receives Emergency Use Authorization from the FDA.
Vela Diagnostics receives CE-IVD approval and Provisional Authorisation from the Health Sciences Authority in Singapore for automated COVID-19 detection test
Vela Diagnostics announced that an automated version of its COVID-19 detection test, the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0, has received the CE mark for in vitro diagnostic use as well as Provisional Authorisation from the Health Sciences Authority in Singapore.
Vela Diagnostics announced today that the manual version of the ViroKey™ SARS-CoV-2 RT-PCR Test has received the CE mark for in vitro diagnostic use. The test detects SARS-CoV-2 in patients suspected of COVID-19 by their healthc
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 24, 2020.
The partnership will support verification and clinical validation of RT-PCR tests to detect the COVID-19 virus.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 20, 2020.
Vela Diagnostics to offer manual ViroKey™ SARS-CoV-2 RT-PCR Test after completion of Emergency Use Authorization validation, targeted to be complete by early April 2020
Ahead of Emergency Use Authorization and in accordance with the U.S. Food and Drug Administration Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency guidance document issued on March 16, 2020, Vela Diagnostics will offer the manual ViroKey™ SARS-CoV-2 RT-PCR Test when validation is completed.
Vela Diagnostics Submitting Novel Coronavirus Diagnostic Test to FDA for Emergency Use Authorization
Vela Diagnostics has developed the ViroKeyTM SA201 COVID-19 RT-PCR Test, a new diagnostic test for the detection of the COVID-19 coronavirus. Vela Diagnostics is currently in discussions with the U.S. Food and Drug Administration for clearance of the test under the emergency use authorization.
FDA Grants De Novo Designation for Vela Diagnostics’ Next Generation Sequencing HIV-1 Genotyping Assay
Vela Diagnostics’ Sentosa® SQ HIV-1 Genotyping Assay is the first FDA De Novo designated Next Generation Sequencing (NGS) assay for detecting HIV-1 drug resistance mutations (DRMs).
The Eastern Pathology Alliance to offer Hepatitis C testing services to the wider NHS capitalising on next generation sequencing technology
The Eastern Pathology Alliance (EPA) announces today that it is to offer Hepatitis C genotyping testing to the wider NHS nationally leveraging its investment in next generation sequencing assays.
Vela Diagnostics Announces FDA Submission of its Next Generation Sequencing (NGS) HIV Genotyping and Drug Resistance Mutation (DRM) Assay
Vela announces FDA submission for the Sentosa® SQ HIV Genotyping Assay, a Next Generation Sequencing (NGS) genotyping and drug resistance mutation (DRM) detection in vitro diagnostic test intended for use as an aid in monitoring and treating HIV-1 infection
First Next-Generation Sequencing Test For HIV Drug Resistance Could Help Combat AIDS Worldwide, Vela Diagnostics Reveals
Vela Diagnostics Announces Launch Of CE-IVD Non-Small Cell Lung Cancer Next-Generation Sequencing Panel
Vela Diagnostics Announces The Listing Of Their Next-Generation Sequencing System With The U.S. FDA As A Class II Medical Device