At a Glance

Vela Diagnostics facts and figures

Sentosa Sx-101
  • Established in 2011
  • Approximately 200 employees worldwide
  • Pioneer in offering both real-time PCR and Next-Generation Sequencing on an integrated platform.
  • More than 30 research or IVD tests in nine disease areas*
  • 15 validated sample types
  • ISO 13485:2003 certified R&D and manufacturing facilities located in Singapore, with additional R&D facilities in United States
  • CLIA-certified laboratory in United States 
  • Global network with direct operations and distributors across North America, Europe and Asia Pacific

*regulatory status of products is based on regional availability

 

Select achievements and milestones

2011

  • Founding of global head office in Singapore, with regional operations set up in New Jersey, US and Hamburg, Germany
  • Distribution agreement with Qiagen and OEM agreement with Eppendorf
  • qPCR license with Roche
  • OEM agreement with Macherey Nagel

2012

  • Start of direct sales in several European markets including Italy, France, UK, Benelux and Scandinavia
  • Establishment of qPCR workflows and first CE-IVD tests
  • OEM agreement with Life Technologies for NGS solutions
  • CLIA lab license in US
  • OEM agreement with Swift Biosciences

2013

  • Start of direct sales in Australia and Malaysia
  • Distribution agreement with AmeriLab for China and Diagnostica Longwood for Spain

2014

  • Start of direct sales in Thailand 
  • NGS license agreement with Appistry
  • Launch of the first NGS-based oncology panel for IVD use in Europe and parts of Asia
  • Distribution agreement with SurgiTech AS for Estonia

2015

  • Direct sales planned for India

2016

  • Licensing agreement with Stanford University for use of HIVdb

  • Launch of NGS based HIV assay 
  • Acquisition of Lifecode Inc’s data interpretation assets

  • FDA emergency authorization for Zika PCR assay

  • Distribution agreement with Diagen AS in Scandinavia

  • Distribution agreement with DYN Diagnostics in Israel

  • Distribution agreement with Advanced Diagnostics in Myanmar

 

2017

  • Start of direct sales in Spain

  • CE-IVD and TGA approval for NGS based HIV and HCV assays 

  • Distribution agreement with MALVA SA in Greece

 

2018

  • Licensing agreement with UCSF for FLASH and DASH enrichment technologies

  • US FDA 510(k) clearance for Herpes Simplex virus PCR assay

  • Acquisition of Great Basin Scientific, a former publicly-held, US-based provider of easy-to-use molecular diagnostics for infectious disease

  • Distribution agreement with Lab Depot in Peru

 

2019

  • Thai FDA and SIngapore HSA approval for NGS-based HIV Genotyping Assay
  • US FDA De Novo Designation for Sentosa® SQ HIV-1 Genotyping Assay

 

2020

  • Launch of SARS-CoV-2 RT-PCR diagnostic assay
  • CE-IVD and HSA Provisional Authorization for ViroKey™ SARS-CoV-2 RT-PCR Test
  • BARDA Funding to develop COVID-19 diagnostic assay
  • Launch of NGS-based ViroKey™ SQ FLEX Genotyping Assay that detects DRMs in HIV-1, HCV, HBV & CMV