Oragene

OraSure’s Oragene®•Dx included in EUA allowing at-home saliva collection for use with Phosphorus SARS-CoV-2 test

Retrieved on: 
Monday, June 8, 2020
Articles, Branches of biology, Laboratory techniques, Technology, Zoonoses, Molecular biology, Polymerase chain reaction, Pneumonia, Severe acute respiratory syndrome, Oragene, Real-time polymerase chain reaction

The Phosphorus COVID-19 RT-qPCR test detects nucleic acid from SARS-CoV-2 in the saliva of individuals who are suspected of being infected with COVID-19 by a healthcare professional.

Key Points: 
  • The Phosphorus COVID-19 RT-qPCR test detects nucleic acid from SARS-CoV-2 in the saliva of individuals who are suspected of being infected with COVID-19 by a healthcare professional.
  • Combined with the easy-to-use OrageneDx (OGD-510) saliva collection device from OraSures subsidiary, DNA Genotek, this is an easily deployable testing option for patient or employee populations and for at-home use.
  • Eligibility to receive an OrageneDx collection device for in-home self-collection will be determined based on a medical questionnaire reviewed by a healthcare professional before shipment.
  • Earlier this month, the Companys ORAcollectRNA kit (OR-100) was included as the collection device for the EUA granted to Biocerna LLC.

DNA Genotek’s ORAcollect®·RNA kit included in EUA granted to Biocerna SARS-CoV-2 test

Retrieved on: 
Monday, May 4, 2020
Molecular biology, Branches of biology, Biology, Biotechnology, Natural sciences, Helices, DNA, Biomatrica, Oragene

ORAcollectRNA is an all-in-one system for the collection, stabilization and transportation of human, microbial and viral RNA.

Key Points: 
  • ORAcollectRNA is an all-in-one system for the collection, stabilization and transportation of human, microbial and viral RNA.
  • We are pleased with the recognition our ORAcollectRNA collection kit has received as part of this Emergency Use Authorization granted to Biocerna, said Kathleen Weber, Executive Vice President, Business Unit Leader Molecular Solutions at DNA Genotek.
  • DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from multiple sample types.
  • DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries.

DNA Genotek Announces FDA General Use Clearance for Oragene®·Dx Family of Products

Retrieved on: 
Wednesday, January 22, 2020
Branches of biology, Biology, Life sciences, Biotechnology, Molecular biology, Medical equipment, Oragene, Medical tests, DNA, Genetic testing, DNA profiling, Genealogical DNA test

OrageneDx is intended for use in the non-invasive collection of saliva samples for in vitro diagnostic testing of human DNA.

Key Points: 
  • OrageneDx is intended for use in the non-invasive collection of saliva samples for in vitro diagnostic testing of human DNA.
  • OrageneDx is now the first and only device with general clearance for collection and stabilization of DNA from saliva for use in genetic testing of human germline DNA, including prescription or over-the-counter (direct-to-consumer) use.
  • DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from multiple sample types.
  • DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries.