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.

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.*

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