Onco Sonar™ Cancer Mutation Profiling Liquid Kit

Trade name

Onco Sonar™ Cancer Mutation Profiling Liquid Kit

UDI-DI code

06975029660129

Basic UDI-DI

B-06975029660129

Reference / catalog number

RSN123

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The kit is intended for qualitative detection of key or guideline-recommended genomic variations in plasma cell-free DNA (cfDNA) samples, cerebrospinal fluid cfDNA samples, and pleural effusion cfDNA samples from advanced solid tumors using NGS-based liquid biopsy. This kit profiles 172 genes, encompassing both clinically significant and high-frequency mutated genes within the tumor population. Utilizing probe hybridization capture technology combined with Next Generation Sequencing (NGS), the kit is capable of detecting point mutations, insertions/deletions, copy number variations, and gene rearrangements. It also provides microsatellite instability analysis and offers reference information on molecular typing, prognosis assessment, targeted medication, immunotherapy, chemotherapy, etc., for personalized precision diagnosis and treatment of pan-cancer advanced solid tumors.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W010699GENETIC TESTS - OTHER

No certificate specifically references this device's Basic UDI-DI.