[Intended use]

The Ultrassay PIK3CA Gene Mutation Detection Kit is a sensitive and selective assay for the detection of five mutations in the phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) gene.

It has been found that PIK3CA gene mutations exist in several types of cancers, including breast cancer and non-small-cell lung cancer. Mutation of PIK3CA may lead to persistent activation of the downstream signaling pathway associated with the development and spread of cancer.

[Principles]

The PIK3CA five mutation kit is a real-time PCR assay. It employs mutation-specific primers and a PIK3CA-targeted proprietary fluorescent probe to detect low-copy number (1%) PIK3CA-mutant DNA in cancer tissue.

The kit enables detection of the following mutations against a background of wild-type genomic DNA.

• H1047R（3140A>G）

• H1047L（3140A>T）

• E542K (1624G>A)

• E545D (1635G>T)

• E545K (1633G>A)