Sentosa SQ OncoKey Core Automated Workflow (CE-IVD)

The Sentosa SQ OncoKey Core Panel is a family of panels consisting of three panels: Sentosa SQ NSCLC Panel, Sentosa SQ CRC Panel and Sentosa SQ Thyroid Cancer Panel. All panels are next-generation sequencing (NGS)-based in vitro diagnostic tests. These CE-IVD marked tests are automated on the Sentosa workflow.

The Sentosa SQ OncoKey Core Panel is intended to be used on the Sentosa SX101 instrument, in conjunction with the Sentosa SX FFPE II gDNA Kit, Sentosa ST401 and Sentosa SQ301 instruments. On this automated workflow, up to 7 samples can be automatically processed and analysed within 2.5 days.

The Sentosa SQ OncoKey Core Panel is intended to be used as a test to aid the oncologist in clinical decision-making. Results should be used in conjunction with other available laboratory and clinical information and are not intended for use as a stand-alone diagnostic test or disease monitoring.

Sentosa SQ OncoKey Core Manual Workflow (RUO)

The Sentosa SQ OncoKey Core Primer Set (96) provides the users a manual solution to test for NSCLC, CRC and thyroid cancer. This test contains the Core Primer pool, OncoKey System Control and barcoded DNA adapters sufficient for up to 16 libraries per run (96 reactions in total). The Sentosa SQ OncoKey Core Primer Set is for research use only (RUO), and not for use in diagnostic procedures.

The Sentosa SQ OncoKey Core Primer Set is designed to be used with the Ion AmpliSeq DNA Library Preparation kits for multiplex targeted libraries from DNA for sequencing on the Sentosa SQ301 instrument or Ion PGM/S5/S5 XL systems, following the manufacturer's instructions for the details of the procedure.

Supporting Clinical Decision-Making:

• Detect 5% variant frequency for mutation
• Sample input: 10 µm section of FFPE sample with > 10 % tumor content
• Get accurate clinical interpretation and reporting with Vela Analytics
• From clinical samples to result in 2.5 days*

Providing Laboratory Efficiency:

• The OncoKey Core Primer Set can be used on different NGS instruments
• 16 different barcoded DNA Adapters, each sufficient for six libraries
• Combine NSCLC, CRC & Thyroid samples in one run
• Seamless sample traceability and IT connectivity
• Flexible manual solution or automated workflow with 3 hours of hands-on time available
• Automated CE-IVD workflow*

*Not available with/applicable for the Oncokey Core Primer Set (RUO)

For availability in your country, please contact your Vela Diagnostics sales representative. Availability is subject to country's regulatory approval.

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