Vela Diagnostics

33 articles with Vela Diagnostics

• Vela Diagnostics Supports COVID-19 Surveillance Efforts in Kenya

  8/3/2022

  Vela Diagnostics has announced its appointment by the National Public Health Laboratory of Kenya as their supplier for SARS-CoV-2 genotyping tests, with funding from The Global Fund.

• Vela Diagnostics Develops PCR-based Test for Detecting Monkeypox Virus

  7/26/2022

  Vela Diagnostics announced that it has developed a PCR test kit to detect the monkeypox virus, for research use only.

• Vela Diagnostics Launches Multiplex PCR-Based Test for Detecting UTI Pathogens and Antimicrobial Resistance Genes

  5/17/2022

  Vela Diagnostics announced today the launch of its new PathoKey® MP UTI ID and AMR PCR Test for research use only (RUO*).

• Media Pooling Strategy to Increase Testing Throughput Added to Vela Diagnostics' ViroKey SARS-CoV-2 RT-PCR Test v2.0

  4/22/2022

  Vela Diagnostics has announced that its ViroKey® SARS-CoV-2 RT-PCR Test v2.0 now has the additional capability to be used for pooling, using a three-in-one media pooling strategy.

• Healthcare providers can expect to receive US$725 reimbursement from CMS when using NGS-based Sentosa(R) SQ HIV-1 Genotyping Assay

  1/7/2022

  Vela Diagnostics announced that its Sentosa® SQ HIV-1 Genotyping Assay is covered for reimbursement from The Centers for Medicare and Medicaid starting January 2022.

• Vela Diagnostics expands automation options for SARS-CoV-2 RT-PCR Test

  11/19/2021

  Vela Diagnostics announced today that the ViroKey®   SARS-CoV-2 RT-PCR Test v2.0 that received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), can now be used with the KingFisher FLEX system and Hamilton Microlab STAR platforms.

• Vela Diagnostics adds two SARS-CoV-2 assays for virus genotyping, and variant identification to its COVID-19 testing solutions

  2/26/2021

  Vela Diagnostics announced that it has added ViroKey™ SQ FLEX SARS-CoV-2 Genotyping Assay and ViroKey™ SARS-CoV-2 ID RT-PCR Test to its portfolio offering.

• Vela Diagnostics' SARS-CoV-2 RT-PCR Test v2.0 Authorized for Emergency Use in the U.S.

  9/23/2020

  Vela Diagnostics' automated COVID-19 detection kit receives Emergency Use Authorization from the FDA.

• FDA issues Emergency Use Authorization to Vela Diagnostics' coronavirus PCR test

  8/6/2020

  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

  7/13/2020

  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 receives CE mark for COVID-19 detection test

  4/24/2020

  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

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  Biopharma Update on the Novel Coronavirus: April 24

  4/24/2020

  Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 24, 2020.

• Vela Diagnostics receives BARDA funding to develop COVID-19 tests

  4/20/2020

  The partnership will support verification and clinical validation of RT-PCR tests to detect the COVID-19 virus.

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  Biopharma Update on the Novel Coronavirus: April 20

  4/20/2020

  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

  3/30/2020

  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

  2/11/2020

  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

  11/6/2019

  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

  8/12/2019

  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

  3/26/2019

  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

• Vela Diagnostics Gets FDA Emergency U.S. Authorization for Zika Test

  9/26/2016