Affymetrix | Panomics Solutions
Quantitative Biology Delivered.

Clinical Applications- Pathway to Clinical Diagnostics

Why RNA as a biomarker

There are numerous benefits for using RNA as a biomarker for clinical applications. An RNA assay can be developed for any expressed protein whereas antibodies may not be available. The time to develop an RNA assay for research use typically takes only weeks whereas the de novo development of an antibody assay for immunohistochemistry (IHC), immunofluorescense (IF) or immunocytochemistry (ICC) typically takes months to years. Manufacture of oligonucleotide probe sets and reagents for the QuantiGene assay have been shown to be highly reproducible with low lot to lot variability. Unlike oligonucleotide probes, antibodies for research applications may suffer lot to lot performance inconsistency, variable affinity and avidity and shelf life or stability issues. IHC is not effective when analyzing fine needle aspirates (FNA) due to poorer sensitivity compared to sensitive RNA ISH assays or when analyzing secreted proteins due to inability to discriminate specific cells secreting the protein within the background of positive signal. RNA assays are necessary to detect the important new class of non-coding RNAs such as mico RNAs (miRNA), satellites or long non-coding RNAs (lncRNAs).

Technology Legacy, Freedom to Operate and Freedom to Sub-License

QuantiGene assays are based on branched DNA chemistry, a non-enzymatic reporter amplification technology, which has been demonstrated to be a reliable platform for nucleic acid testing and an alternative to PCR in the clinical laboratory. The bDNA technology is utilized by Siemens Healthcare Diagnostics in their FDA approved, Versant assays for HCV and HIV viral load diagnostic testing. Affymetrix is the exclusive licensee of branch DNA from Siemens with the right to practice and sub-license bDNA for IVDs in the field of in situ hybridization assay applications.

Affymetrix Clinical Diagnostics Infrastructure and Quality System

  • Affymetrix currently manufactures FDA-cleared GeneChip reagents and instrument systems for the clinical diagnostic market.
  • Affymetrix has met the requirements for CE marking for IVD medical devices in the European Union.
  • For ViewRNA automated assays, Affymetrix is collaborating with partners having cleared products and/or manufacture under GMP in addition to those assay components manufactured within Affymetrix.

Affymetrix Diagnostics Experience- Powered by Affymetrix Clinical Development Partner Program

  • The Powered by Affymetrixâ�¢ program provides a standardized platform for developing new novel molecular diagnostic tests. Affymetrix platforms are fully scalable to support discovery of biomarkers and the ultimate development and validation of informative genetic signatures. The Affymetrix GeneChip Dx System has achieved CE marking and FDA clearance for in vitro diagnostic use. Affymetrix has a growing list of "Powered by Affymetrix" clinical diagnostic partners including Pathwork Diagnostics, Almac, Signature Diagnostics and GenomeDx with FFPE cancer tests.
  • Affymetrix can manufacture your assay to your exact specifications. Throughout this process, we partner with you to understand your needs and assay requirements to ensure that delivery of a high quality and reproducible assay. As part of the contract manufacturing process for your assay, we can prepare a custom clinical validation plan for your gene or genes of interest to determine assay specificity and sensitivity, we can provide appropriate controls, we can manufacture under ISO13485 and cGMP and we can provide appropriate certificate of analysis.

Contact us for further information

For more information regarding our assays and products, please contact your local sales representative