• 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