FDA Authorization
FDA Authorization
Companion Diagnostics (CDx) Test
At the heart of all FDA’s medical product evaluation decisions is a judgment about whether a new product’s benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. With the ONCO/Reveal™ Dx Lung and Colon Cancer Assay, it is trustworthy that the listed colorectal cancer (CRC)-targeted therapies and non-small cell lung cancer (NSCLC)-targeted therapies can be used as one of the guidelines for prescription. It fills the loopholes in the usage of unstandardized medical device.
MiSeqDx System
In Hong Kong. we are the first who utilize the MiSeq DX system to sequence the genetic profile in the tumour samples and generate report with guidelines for prescription. The MiSeqDx instrument meets stringent performance characteristics, so we can generate accurate and reliable data. For more details, please visit the website of Illumina.
FDA-Regulated and CE-IVD-Marked NGS System
The MiSeqDx instrument is the first Food and Drug Administration (FDA)-regulated and Conformite Europeene in vitro diagnostic (CE-IVD)-marked platform for NGS. The MiSeqDx instrument meets stringent performance characteristics so you can feel confident you are generating accurate and reliable data. With the MiSeqDx System, clinicians and clinical laboratories now have the tools to obtain comprehensive and reliable DNA sequencing results.
A Growing IVD Menu
Designed specifically for clinical laboratories, the MiSeqDx System delivers a broad range of sequencing applications right at your fingertips. Illumina offers two FDA-cleared cystic fibrosis assays and an FDA-approved companion diagnostic to aid in the identification of patients with colorectal cancer for treatment with Vectibix.*
*Vectibix is a registered trademark of Amgen, Inc.
Simple NGS Workflow
The MiSeqDx instrument provides an easy-to-use, automated workflow. An intuitive touch screen interface makes for simple instrument operation. Plug-and-play reagents with RFID tracking make for added security and convenience. The MiSeqDx instrument eliminates the need for auxiliary hardware and computing resources, saving valuable lab space.
User-Friendly, Intuitive Software
A user-friendly touch screen interface guides you as you create and set up your sample sheet, then load the sequencing cartridge (provided with pre-loaded reagents). During the run, the system allows you to monitor quality statistics. After DNA sequencing completes, the system software analyzes assay data and generates the results report.*
* Report generation is only available for the TruSight Cystic Fibrosis 139-Variant Assay, the TruSight Cystic Fibrosis Clinical Sequencing Assay, and the Extended RAS Panel.
Workflow
Choose from our menu of FDA-cleared assays available exclusively on the MiSeqDx System.
The MiSeqDx instrument provides accurate, reliable data for screening and diagnostic testing.
The selected analysis initiates automatically. It completes in a few hours and then generates a report.*