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Mimix™ PTEN Loss, FFPE Reference Standard

Consistent and reliable cell-line based reference material replicating PTEN loss in FFPE format

Phosphate and tensin homolog (PTEN) tumor suppressor gene is involved in the modulation of cell cycle progression by negatively regulating the PI3K-Akt signaling pathway which is responsible for cell survival and growth. The loss of PTEN gene (either partial or complete) leads to dysregulation of PI3K-Akt signaling pathway thereby leading to rapid cell growth and cancer progression. PTEN deletion is a prominent prognostic biomarker in prostate cancers along with AR gene copy number gain. Additionally, PTEN loss is also reported in several other pathologies like lung, ovary, endometrium, breast and colon cancers.

This FFPE reference standard contains a cell-line with homozygous deletion (copy number loss) of PTEN to mimic the loss of PTEN observed in several cancers. This product is manufactured in FFPE format under ISO 9001 and ISO 13485. This product will enable the development or monitoring of the efficacy of companion diagnostic tests manufactured to detect PTEN deletion.

Technical Product Information

Format: FFPE

Fixation method: 4% PFA (w/v)

Section size: 15µm

Cell density: 3 x 108 cells per block. Approx. 3.5 x 105 cells per section

Expected DNA yield: > 400 ng using Promega Maxwell RSC FFPE Plus DNA Extraction kit

Genes covered: PTEN

Verified mutations:

Gene DNA sequence change Amino acid change Expected copies
PTEN Deletion N/A 0.00

 

General information

Storage: 4°C

Shipping: Ambient

Expiration: See all product shelf life information

 

Quality control

Allelic frequency: Droplet Digital™ PCR

Quantification: Quantifluor

DNA Integrity: Agarose gel electrophoresis

Manufacturing Quality: ISO 9001:2015 and ISO 13485:2016

Intended use: For assay developers and molecular diagnostic labs for routine performance monitoring of molecular biology assays. Research use only. Not for diagnostic procedures.