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PIK3CA encodes one of the catalytic subunits of phosphatidylinositol 3-kinase (PI3K), a lipid kinase involved in PI3K-AKT-mTOR signaling. PIK3CA mutations resulting in increased PI3K catalytic activity and oncogenic transformation are well-described in many types of cancer. The detection of these mutations can have important treatment implications. Alpelisib (Piqray) is FDA-approved for the treatment of postmenopausal patients with HR+, HER2-, PIK3CA-mutated metastatic breast cancer following progression on or after endocrine-based therapy. This DNA test is performed by targeted next-generation sequencing (NGS) and will detect PIK3CA mutations within the sequenced regions of exons 2, 5, 6, 8, 10, 14, 19 and 21 (NM_006218). Commonly mutated codons covered by this assay include R88, N345, C420, E542, E545, Q546 and H1047. See below for more information regarding sequenced regions of PIK3CA.
Interpretive report provided.
* Reference ranges may change over time. Please refer to the original patient report when evaluating results.
For formalin-fixed, paraffin-embedded tissue, a block containing an area with a high percentage of neoplastic cells (for micro-/macro-dissection) is preferred. Unstained, UNBAKED slides (5-8, 10-micron slides; 10-15 if few neoplastic cells are present) with associated H&E stained slide are also acceptable. Decalcified tissue or other fixatives will be accepted and the assay attempted; however, these may result in failed testing due to degraded nucleic acid. Both blocks and slides should be stored at room temperature. A Diff-Quik or Papanicolaou stained aspirate smear (preferable containing a high percentage and overall amount of neoplastic cells) is also acceptable. Store at room temperature