Genetically Defined Standard Controls
Standardization of DNA extraction from tumor tissue samples and a lack of knowledge of the genetic variability in the tissue samples are currently major challenges in biomarker discovery, diagnostics development, and molecular testing in the laboratories. The availability of genetically defined reference standards will provide an industry standard for development and quality control of molecular assays, directly improving their accuracy. Positive and negative control biospecimen and materials are essential in genetic and biomarker research and clinical diagnostics development. Fine tuned with mutation specified tissue samples are the gold standard for validation of assays.
BioChain offers genetically defined controls for biomarker discovery and validation. This includes our conventional standard products and services as well as the next generation sequence (NGS) based mutation chracterized tissue samples. The FFPE and frozen tissue arrays of lung cancer, breast cancer, colon cancer and FDA standard array formats, and antibody validation service on tissue arrays are offered and used by our drug and diagnostics development customers. Our product lines include normal tissue controls for various solid tumors, the matched pairs of normal versus tumor and primary tumor versus metastatic tumors. Our cancer driver gene mutation characterized FFPE tissue sections and blocks serve as the godl standard controls for the natural occuring variations in the specific cancer research area. The genes we have sequenced include:
ABL1, AKT1, ALK, APC, ATM, BRAF, CDH1, CDKN2A1, CSF1R, CTNNB1, EGFR, ERBB2, ERBB4, FBXW7, FGFR1, FGFR2, FGFR3, FLT3, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, JAK2, JAK3, KDR, KIT, KRAS, MET, MLH1, MPL, NOTCH1, NPM1, NRAS, PDGFRA, PIK3CA, PTEN, PTPN11, RB1, RET, SMAD4, SMARCB1, SMO, SRC, STK11, TP53, VHL
The tissues are also used in the extraction for standard control products, such as normal genomic controls. Our genomic DNA controls are available for human and other animal and plant species. In addition, we also have other types of standard and controls for genomic and molecular biology research, such as cDNA controls, siRNA controls, Methylated DNA controls, Telomerase Positive Control Cells, etc.
The following are our focuses in the area of controls for research and development:
• Standard genomic DNA for various species
• Tissue controls
• Protein lysate controls
• cDNA controls
• RNA controls